2014 vol 20 no 2 pg 67 138

J Res Educ Indian Med, April - June 2014; XX (2): 67--138

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EDITOR-IN-CHIEF

Prof. R.H. SINGH

ABMS, Ph.D, D.Sc.

Distinguished Professor-Kayachikitsa Formerly Vice Chancellor, Rajasthan Ayurveda University; Dean, Faculty of Ayurveda, Institute of Medical Sciences, BHU, Varanasi - 221005 UP (India)

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FOUNDING Editor

Prof. Suresh Kumar

M.D.(Ay), Ph.D (BHU)

Formerly Dean, Faculty of Ayurveda, Himachal Pradesh University, Shimla Director, Indian Institute of Panchakarma, CCRAS (AYUSH, MoH&FW, GoI) (Kerala)

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M.S.(Ay.),Ph.D (BHU)

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Prof. Ravindra G. Mali

M.Pharm, DHMM,

Principal, Shree Swaminarayan College of Pharmacy, Kalol, Gandhinagar (Gujarat)

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M.Sc., Ph.D.

Asso.Professor, Immunology & Cell Biology, Institute for Technology & Research Innovation (ITRI), Deakin University, Victoria - 3217 (Australia)

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President, California College of Ayurveda E-mail: drh@ayurvedacollege.com

ASSISTANT EDITORS Dr. Dr. Dr. Dr. Dr. Dr.

Anagha Ranade (GAU, Jamnagar) Neetu Singh (BHU,Varanasi) Rasika Kolhe (GAU, Jamnagar) Samita Puri (CBPCAS, Delhi) Shweta Dewan (NIA, Jaipur) Vinamra Sharma (BHU, Varanasi)

JREIM ADMIN. OFFICE:

Dr. (Mrs.) Laxmi Bhargava

CONTENTS Clinical Evaluation of Vanga Bhasma in the Management of Madhumeha (Type-2 Diabetes Mellitus) B. J. Patgiri, Darshan K. Parmar and P. K. Prajapati … 67-74 Formulation Design and Evaluation of AntiInflammatoryactivityof Commiphora mukul Loaded Emulgel Tejinder Kaur Marwaha and Kiran S Bhise … 75-87 Effectiveness of Mindfulness Bsed Cognitive Therapy on anxiety, Stress and Depression of Pregnant Youths: A Randomized Clinical Trial Seyed Khadijeh Seyed Musavi and Mohammad Narimani … 89-93 An Observational Clinical Study on Effect of Ushtrasana (Yoga) in Management of Katishula (Low Back Pain) and Manyashula (Neck Pain) Yadav Archna, Shukla Rakesh, Patwardhan Ravindra and Arora Manish …

Role of Stress Factor in the Pathogenesis of Diabetes mellitus and its Treatment with Medhya Rasayana- A Clinical Study Baldev Kumar, Shweta Dewan, Hetal Dave and Puspendra

95-101

… 103-112

Clinical Evaluation of Kesharaja Tailain the Management of Khalitya Pramod Yadav, Priyanka Verma, Neelesh Khandelwal and Pradeep Kumar Prajapati … 113-119 Therapeutic Vistas of Guduchi (Tinospora cordifolia (Willd.)

Miers): A Medico-Historical Memoir Rohit Sharma, Hetal Amin, Galib and P.K. Prajapati … 121-136 Conferences and Forthcoming Events Announcements

Ph.D. (BHU)

Executive Editor E-mail: drlaxmi_ayush_journal@yahoo.com

Standard International ISO Abbreviation of JREIM is: J. Res. Educ. Indian. Med.

… 137-138

NLM ID : 8602438 (NlmId)

ISSN : 0970-7700 (Print)

JOURNAL OF RESERCH AND EDUCATION IN INDIAN MEDICINE Journal of Research and Education in Ayurveda, Yoga, Naturopa Unani, Siddha, Homeopathy,Complementary and Alternative Medicine, Integrative Medicine, Medicinal and Aromatic Plants,Pharmaceutical Sciences …… An International Quarterly

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Prof. R.G. Singh Chief Editor

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Director, Institute of Medical Sciences Banaras Hindu University, Varanasi (India)

Distinguished Professor, Institute of Medical Sciences Banaras Hindu University, Varanasi (India)

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J. Res. Educ. Indian Med.,April-June 2014; XX (2): 67-73

ISSN 0970-7700

CLINICAL EVALUATION OF VANGA BHASMA IN THE MANAGEMENT OF MADHUMEHA (TYPE-2 DIABETES MELLITUS) B. J. PATGIRI,1 DARSHAN K. PARMAR2 AND P. K. PRAJAPATI3 Department of Rasashastra and Bhaishajya Kalpana including Drug Research, I.P.G.T. & R.A., Gujarat Ayurved University, Jamnagar-361008, Gujarat (India) Abstract: Introduction: Madhumeha is a Vataja type of Tridoshaja disease. Vanga is used abundantly in practice of Ayurveda for the treatment of Madhumeha. It is a drug of choice for the management of Madhumeha (DM-II). Guduchi Ghana ( aqueous extract of Tinospora cordifolia (Willd.) Miers) of is also having Mehahara effect and old honey is also to be claimed for Mehaghna properties. Material and methods: In present study total 64 patients were registered. Out of them in Group A total 32 patients were managed with Vanga Bhasma (250 mg) along with Guduchi Ghana (250 mg) + Old Honey (3 ml) as Sahapana whereas in Group B, 32 patients were managed with Guduchi Ghana (250 mg) + Old Honey (3 ml) for 28 days. Observations and Results: Present study 14%, 28% and 10% of patients markedly improvement, moderate improvement, mildly improvement were found in Group A respectively. While 2%, 10% and 24% markedly improvement, moderate improvement, and mildly improvement were found in Group B respectively. Overall result showed that Vanga Bhasma possesses the antihyperglycemic effect along with its Sahapana and it doesn’t have hypoglycemic effect. Conclusion: Vanga Bhasma with Sahapana (Guduchi Ghana) was found moderate anti-hyperglycemic agent in the patients of Madhumeha (Type-2 Diabetes Mellitus)).

Keywords: Ayurvedic treatment; Diabetes mellitus; Guduchi Ghana; Madhumeha; Madhu; Honey; Vanga Bhasma.

Introduction Madhumeha is Vataja type of Prameha and Vata-Pradhana Tridoshaja disease (Charaka Nidana 4/45-46).[3] If not properly treated in time then all types of Prameha will ultimately produce Madhumeha which is difficult to cure (Sushruta Nidana 6/30).[9] In Charaka Nidana 4th chapter (Prameha Nidana) in the description of Vatic Meha Samprapti narrates that when vitiated and depleted Doshas by its Laghu and Ruksha properties also vitiates Ojas and this Ojas is excreted by renal then leads to Madhumeha.

(Charaka Nidana 4/37) [3] In Madhumeha, urine is like honey (sweet in taste) (Ashtang Hridya, Nidana 10/18) [10] Madhumeha is of two types, viz. one due to Vata Kshaya caused

by Dhatu Kshaya (depletion of tissues) and another by Vata Vriddhi caused by obstruction of the Channels of Vata by the other Doshas (Madhava Nidana, Madhukosha 33/24).[7]

In spite of many advances, the allopathic management of diabetes still remained unsatisfactory. Insulin resistance, hypersensitivity, drug intolerance, and hypoglycemic episodes make it all more important to search out safe, effective drugs. Vanga Bhasma is a drug of choice for the management of the disease Madhumeha (Ashtang Hridya, Nidana Sthana 10/21).[10] Vanga Bhasma is also used in many formulations which claim to have Mehahara properties (Ayurveda Prakasha, 3/151).[6] Guduchi Ghana (aqueous extract of Tinospora cordifolia (Willd.) Miers) is also used for the management of Madhumeha (Acharya YT, 1995)[2] with old honey which is having Grahi, Ruksha, Medoghna-atilekhana properties (Bhavaprakasha Nighantu, Madhu Varga/25). [5] The aims of study this is to evaluate the efficacy of Vanga Bhasma (along with Sahapana) in Madhumeha (Type-2 diabetes mellitus).

1.Associate Professor. 2. Medical Officer, 3. Professor and Head

68

Patgiri, Parmar and Prajapati

Materials and Methods 1. Patients : Patients attending the O.P.D. and I.P.D. of I.P.G.T. and R.A., Gujarat Ayurved University, Jamnagar having classical symptomatology of Madhumeha (DM-II) were selected. A detailed proforma was prepared.

Physical examinations of the patient and detailed history were taken.

2. Drugs : Vanga Bhasma along with Guduchi Ghana in capsule form was prepared and and old honey was also given separately for the study.

Vanga Bhasma (Rasamritam 3/88-94).[1] and Guduchi Ghana (Siddhyogsamgraha, Jwaraadhikara) [2] were prepared in the department of Rasashastra and Bhaishajya Kalpana of I.P.G.T. & R.A., Gujarat Ayurved University, Jamnagar Gujarat (India).

3. Inclusion criteria: Patient with classical symptomatology of Madhumeha (DM-II) also who were taking allopathic medicine however their blood sugar was not controlled age group 25 – 75 years and fulfillment of diagnostic criteria were selected.

4. Diagnostic criteria: Signs and symptoms of Madhumeha (DM-II). Standard criteria of National Diabetes Data Group and W.H.O. for DM-II was adopted which are (adopted by American Diabetes Association, 1997)[4] symptoms of Diabetes + Random Blood Glucose 200 mg/dl or fasting blood glucose 126 mg/dl or two hours blood glucose 200 mg/dl (during an oral glucose tolerance test) 5. Exclusion criteria: Patients of diabetes mellitus who were receiving insulin also who having chronic complications of diabetes mellitus like (Micro vascular i.e. Retinopathy, Neuropathy and Nephropathy and Macro vascular i.e.

Coronary Artery Disease, Peripheral vascular disease and Cerebro-vascular disease).

6. Investigations: Hematological examinations like Hb %, TLC, DLC, ESR, urine sugar and

biochemical examinations such blood sugar: Fasting and post-prandial, Lipid profile, Liver function test and Renal Function Test to assess the functional status of kidney and liver.

7. Study design: Present study was randomly double blind study. Informed consent was taken from the patient before including them in the trial.

Management of the Patients: This includes five basic steps grouping, dose and duration, method of drug administration, advice regarding Pathya-Apathya and criteria for assessment.

1. Grouping : Selected patients were randomly divided into two groups.

2. Dose and Duration: Group A: Vanga bhasma 250 mg with Guduchi Ghana 250 mg capsule b.i.d with old honey in separate bottle. Group B: Guduchi Ghana 250 mg b.i.d capsule with old honey in separate bottle and both the test drugs were given for four weeks. Total 32 patients were registered in Group A, 27 completed the treatment, remaining five discontinued and total 32 patients were registered in Group B, 23 completed the treatment and remaining nine discontinued.

3. Method of drug administration: In both groups, patients were instructed to open the capsule in palm take Honey in as such quantity that the whole mixer was suitable for licking and it was taken 45 min before meal.

4. Pathya-Apathya : Patients were advised to restrict carbohydrate diet, correct their dietary habits. Mild to moderate exercise as per their capacity was suggested. Also they were advised not to take Dadhi (curd) in their diet.

5. Criteria for Assessment: Drug was given to the patients weekly. After taking all investigations and the changes in subjective parameters of specific rating scale were recorded at weekly

Vanga Bhasma in the Management of Diabetes Mellitus

interval. After completion of treatment all investigations were taken again and all objective parameters were utilized for statistical analysis.

Obtained results were measured according to the grades like control of the disease;100% relief, marked improvement; 75% to 99% relief, moderate improvement; 50% to 75% relief, mild improvement; 25% to 50% relief and no improvement; <25% relief.

Statistical analysis Figure 7 Obtained data were expressed as MEAN ± SEM. The data were analyzed by paired ‘t’ test, level of P < 0.05 and P < 0.01 were considered as statistical significant and highly significant respectively.

69

Observations It was found that patients were maximum reported from age group 56-65 years i.e. 40.22 %. As per sex wise distribution, males and females patients were i.e. 48.91%, 51.09% respectively. Maximum patients were housewife (53.36%). Majority of the patients i.e. 46.74 % reported to have chronicity > 1 but < 5 years.

All patients had Dvandvaja Pakriti. Total 41.30% of Vata-Kapha Prakriti dominated was found.

This may be because of the influence of Jangala Desha and Guru, Snigdha Gunapradhana Ahara at the time of conception. Pitta-Kapha Prakriti was found in 36.96%. This shows dominance of Kapha in Prakriti. Majority of the patients having Madhyama Sara, Satva, Samhanana and Koshta which were 88.04%, 81.52%, 84.78%

Table 1. Effect of therapy on cardinal symptoms in both groups Symptom Prabhuta-mutrata Avila-mutrata Trishna-adhikya

Mean ± SEM

Group (n)

B.T.

A.T.

A(26)

2.96 ± 0.20

1.35 ± 0.17

1.62 ± 0.17

54.39Ļ

9.53**

B(23)

1.78 ± 0.18

1.43 ± 0.20

0.35 ± 0.16

19.66Ļ

2.19©

Change

Percentage change

‘t’

A(26)

2.81 ± 0.19

1.42 ± 0.15

1.39 ± 0.21

49.47Ļ

6.62**

B(23)

1.57 ± 0.16

1.22 ± 0.18

0.34 ± 0.15

33.33Ļ

2.27©

A(16)

2.69 ± 0.27

1.56 ± 0.18

1.13 ± 0.31

42.01Ļ

3.65*

B(16)

1.69 ± 0.20

1.06 ± 0.22

0.63 ± 0.18

37.28Ļ

3.50*

Kara-Pada-Tala Daha

A(21)

2.71 ± 0.20

0.43 ± 0.15

2.29 ± 0.24

84.13Ļ

9.54**

B(16)

1.69 ± 0.26

1.13 ± 0.26

0.56 ± 0.18

33.14Ļ

3.11*

Kara-Pada Suptata

A(21)

2.67 ± 0.25

0.71 ± 0.18

1.95 ± 0.25

73.41Ļ

7.80**

Daurbalya Pindikodweshtana Klaibya Shrama pratiti Kshudha-adhikya

B(16)

1.81 ± 0.27

0.88 ± 0.20

0.93 ± 0.17

51.38Ļ

5.47**

A(25)

2.84 ± 0.23

0.96 ± 0.18

1.88 ± 0.20

66.20Ļ

9.40**

B(19)

1.47 ± 0.18

1.26 ± 0.25

0.21 ± 0.29

14.29Ļ

0.72

A(16)

2.63 ± 0.30

0.88 ± 0.16

1.75 ± 0.35

66.54Ļ

5.00**

B(11)

1.27 ± 0.19

1.36 ± 0.29

0.90 ± 0.16

07.09Ĺ

5.63**

A(4)

3.00 ± 0.41

1.50 ± 0.87

1.50 ± 0.50

50.00Ļ

3.00

B(11)

1.73 ± 0.26

2.09 ± 0.27

0.36 ± 0.24

20.81Ĺ

1.50

A(16)

2.68 ± 0.25

0.93 ± 0.23

1.75 ± 0.31

65.30Ļ

5.65**

B(13)

1.54 ± 0.23

1.31 ± 0.25

0.23 ± 0.30

14.49Ļ

0.77

A(13)

2.08 ± 0.26

1.00 ± 0.22

1.08 ± 0.40

51.92Ļ

2.70©

34.76Ļ

3.35*

B(14) 1.64 ± 0.19 1.07 ± 0.23 0.57 ± 0.17 © = < 0.05, * = <0.01, ** = <0.001, Ļ = Decrease, Ĺ = Increase, n = Number of patients.

70

Patgiri, Parmar and Prajapati

and 75.00% respectively. Positive family history was found in 42.39% of patients. Most of the patients were found to be consuming MadhuraAmla-Lavana Rasa Ahara-abhiruchi.

Diwaswapa, Avyayama and Dadhisevana were observed in 61.96%, 54.35% and 54.35% of patients respectively.

Cardinal symptoms like Prabhuta Mutrata, Avila Mutrata and Daurbalya were seen in maximum percent of patients i.e. 84.78 %, 85.87 % and 75 % respectively, followed by KaraPada-taladaha (69.57%) and Kara-Padasuptata (65.22%). Shrama pratiti, Kshudhadhikyata, Pindikodweshtana, Trishnadhikya was seen in 52.17 %, 50 % and 42.39 %, 56.52% of patients respectively while Klaibya was observed in 22.83 % of patients. 75.5 % patients in both groups who were taking modern anti-hyperglycamic drugs but their blood sugar level was not under control also felt relief. During study period their respective modern medicine was continuing.

Results On decoding the drug at the end of study it was found that the Group A contains Vanga Bhasma along with Guduchi Ghana and Group B contains Guduchi Ghana.

Effect of therapy on cardinal symptoms: Statistically significant decrease was found in all symptoms in Group A except in Klaibya (Table 1).

In Group B marginal decrease was found in Daurbalya, Shramprati and mild to moderate increase was found in Klaibya but it was no significant. Rest of symptoms in Group B was statistically significant Effect of therapy on hematological and biochemical parameters: Statistically significant decrease was found in BSL – Fasting and Postprandial in Group A (Table 2). All Other data shows marginal and

Table 2. Effect of therapy on hematological & biochemical parameters in both groups Parameter Hb% ESR U. Sugar BSL- Fasting

Group (n)

Mean ± SEM B.T.

A.T.

Change

Percentage change

‘t’

A(27)

11.91 ± 0.32

11.92 ± 0.33

0.01 ± 0.19

0.08Ĺ

0.05

B(23)

12.24 ± 0.79

12.14 ± 0.64

0.10 ± 0.14

0.82Ļ

0.71

A(27)

29.11 ± 3.61

28.88 ± 5.36

0.22 ± 4.67

0.79Ĺ

0.05

B(23)

18.43 ± 2.99

23.65 ± 3.05

5.22 ± 2.46

28.32Ļ

2.18©

A(11)

2.36 ± 0.36

2.00 ± 0.50

0.36 ± 0.75

15.25Ļ

0.48

B(12)

3.08 ± 0.66

2.75 ± 0.35

0.33 ± 0.61

10.71Ļ

0.54

A(27)

208.52 ± 17.56

174.56 ± 15.41

33.96 ± 14.32

16.29Ļ

2.37*

B(23)

176.52 ± 14.72

193.17 ± 16.43

16.65 ± 09.02

9.43Ĺ

1.85

BSLPostprandial

A(27)

259.41 ± 24.57

218.74 ± 19.77

40.67 ± 18.78

15.68Ļ

2.17©

B(23)

254.22 ± 27.38

261.35 ± 21.11

07.13 ± 15.79

02.80Ĺ

0.45

Serum Cholesterol

A(27)

192.63 ± 07.65

198.78 ± 06.80

06.15 ± 7.40

3.19Ĺ

0.83

B(23)

184.96 ± 12.74

180.09 ± 11.10

04.87 ± 8.38

2.65Ļ

0.58

Serum Triglyceride

A(27)

156.22 ± 15.90

163.67 ± 14.47

07.45 ± 16.47

04.77Ĺ

0.45

B(23)

125.26 ± 15.64

128.91 ± 15.19

03.65 ± 16.67

02.91Ĺ

0.22

A(27)

40.99 ± 1.11

47.52 ± 2.03

6.53 ± 2.28

15.93Ĺ

2.86*

1.53Ļ

0.76

Serum HDL

B(23) 39.78 ± 2.45 39.17 ± 1.74 0.61 ± 0.80 © = < 0.05, * = <0.01, Ļ = Decrease, Ĺ = Increase, n = Number of patients.

Vanga Bhasma in the Management of Diabetes Mellitus

mild to moderate decrease and increase but it was not up to statistically significance.

Total effect of therapy: Vanga Bhasma showed markedly improvement in 14%, moderate improvement in 28% and mildly improvement in 10% of patients with its Sahapana (Guduchi Ghana + old honey).

While Guduchi Ghana + old honey showed markedly improvement in 2%, moderate improvement in 10% and mildly improvement in 24 % of patients. While 2% and 10% of patients remains unchanged in Group A and Group B respectively. Overall result showed that Vanga Bhasma possesses the antihyperglycemic effect along with its Sahapana and it doesnâ&#x20AC;&#x2122;t have hypoglycemic effect (Figure 1).

Discussion Maximum patients were reported from 56-65 years age group (40.22 %) that shows dominancy of Vata Dosha. At this particular age lay a solid foundation for Vata disorders. At the same time Guru, Snigdha, Madhura Bhojana, Diwaswapa etc. causes Kapha-Meda-Dushti.

This is the period in life in which persons get exposed to variety of stresses. Chinta causes Figure 1. Over all effect of therapy

71

Kapha, Rasa, Meda and Vata vitiation. This stress causes imbalance in hormonal and nervous regulation of the body and makes the person susceptible to many hormonal disorders including DM-II. It is also well known fact that type II DM more typically develops with increasing age.

Sex wise distribution doesnâ&#x20AC;&#x2122;t shows much more difference of prevalence of disease. Majority of the patients were housewife, this may be one of the reasons for Kapha-Medo-Dushti due to their sedentary lifestyle. Vata-Kapha and Pitta-Kapha Prakriti were found 41.30% and 36.96% respectively. It shows dominance of Kapha in Prakriti. This may be because of the influence of Jangala Desha and Guru, Snigdha Gunapradhana Ahara at the time of conception.

By analyzing the dietary habitual and lifestyle data, it can be inferred from this study that the Kaphakaraka Ahara and sedentary life style were the most common Nidanas behind the manifestation of this disease. Also Dadhisevana (54.35%) shows dietary tradition factor.

Statistical significant results were found in all cardinal symptoms except Klaibya. Reasons behind the positive effect are discussed in probable mode of action of drug but in Klaibya the result was not found satisfactory up to the

72

Patgiri, Parmar and Prajapati

text claimed for it. Vanga Bhasma claimed the best Vrushya (Ayurveda Prakasha, 3/152) [6] and Vajikara (Ayurveda Prakasha, 3/153).[6] There may be a clear vision that Vanga Bhasma possesses its above claimed efficacy when it was planned to made by those Shodhana, Jarana

by Vata-Ashwatha or Babbul twaka and Marana dravyas which also possesses the Vrushya properties. There may be other reason that the Sahapana Guduchi Ghana possesses excessive Tikta rasa which contrast to the Vrushya and Vajikara effect (Charaka Samhita, 26/43).[3] Purana Madhu (old honey) having Grahi, MedoSthaulyapah, Atilekhana properties (Sushruta Samhita, 45/141) [9] which ultimately contrast to the Vrushya effect of Vanga Bhasma. Over viewing the results of the study, Vanga Bhasma seems to be very effective in the management of Madhumeha (Diabetes mellitus). Point should be noted that about 75% of the registered patients were taking oral hypoglycemic since years together. After starting the test drug, their average fasting blood glucose was reduced by 33.96 mg/ dl within 2hrs in Group A and average decrease in 2 hrs plasma glucose was 40.67 mg/dl in Group B. So it may be concluded that Vanga Bhasma has antihyperglycemic effect as well as synergistic action with oral hypoglycemic agents.

Though the other biochemical parameter were didnâ&#x20AC;&#x2122;t vary much more and create any infer that was statistical significance.

Probable mode of action: Here Vanga Bhasma, was prepared by using Samanya Shodhana of Lohas (Rasaratnasamuccaya, 5/13).[8] and Vishesha Shodhana were done by using Nirgundi Patra Swarasa+Haridra churna (Rasamritam, 3/ 87),[1] so the Tikta-Kashaya Rasa, Vatashleshmahara guna of Nirgundi (Bhavaprakasha Nighantu, Guduchyadi Varga /114) [5] and Katu-Tikta Rasa, Ruksha Guna, Ushana Virya, Mehaharaguna of Haridra (Bhavaprakasha Nighantu, Haritkyadi Varga/ 197) [5] may be induced in Vanga during Samskara (Shodhana).

Jarana was done by using Apamarga Panchanga which is having Tikta-Katu Rasa, Kapha-medo-anilapah properties (Bhavaprakasha Nighantu, Guduchyadi Varga/ 220).[5] Bhavana was given by Kumari Swarasa which also induced the properties of Tiktarasa, Bhedana so most probable the Bhasma became Tikta-Katu-Kashaya Rasa, Laghu-Ruksha, Kaphamedo-Vatahara Guna, Sheeta Virya and Katu Vipaka. These properties were found only on the basis of its therapeutic effect however the Bhasma, itself having no taste.

The Sahapana (Guduchi Ghana) having Katu-Tiktarasa, Tridoshahara and Mehahara.

Honey was used in this study which was unintentionally collected by scholar from his under graduation study so it was considered old which also have properties like Grahi, Ruksha, Medoghna-atilekhana (Bhavaprakasha Nighantu, Madhu Varga/25).[5] All above properties might have corrected the Kapha-Medo Dushti. Along with this, it contains the Tikta-Kashayarasa, which might have corrected the vitiation of Pitta in this way; Vanga Bhasma acted on Kapha-Pitta and the Sahapana (Guduchi Ghana + Purana Madhu) also helps to correct Kaphavargiya Dushyas, hence providing significant relief in the cardinal symptoms of Madhumeha.

This Vanga Bhasma, considering its Sheeta Virya may have been effective on Pittadosha also. Due to all these properties Vanga Bhasma along with Guduchi Ghana helps to correct Dhatudushti as well as Srotodushti, thus result in normal functioning of body.

Conclusion Vanga Bhasma is clinically effective moderate anti-hyperglycemic agent and has no hypoglycemic effect when it is given with the Sahapana of Guduchi Ghana + Purana Madhu (old honey).

Madhumeha, as the disease condition having its Yapyatva the Vanga Bhasma can give effective and safe medicament.

Vanga Bhasma in the Management of Diabetes Mellitus

Acknowledgements We are thankful to the Director, I.P.G.T.and R.A., Gujarat Ayurved University, Jamnagar, Gujarat (India) for financial support to carry out this research work.

1 2.

3.

4.

5.

References Acharya Y.T. Rasamritam, (3:87) and (3:88-94).

Varanasi, Motilal Banarasi Das, 1951.

Acharya Y.T. Siddhyogsamgraha, (1st chapter (Jwara-adhikara).11th ed., Patna, Shri Baidyanatha Ayurved Bhavan Ltd, 1995.

Agnivesha. Charaka Samhita , Sutra Sthana (26:43); Nidana Sthana (4:37) and (4:45-46), Ayurveda-Dipika commentary by Chakrapanidutta, Varanasi, Chaukhambha Surbharati Prakashan, 2005.

American Diabetes Association. Diabetes Care, Report of the Expert Committee on the diagnosis and classification of diabetes mellitus, 1997;20(7); 1183â&#x20AC;&#x201C;97.

Bhavamishra. Bhavaprakasha Nighantu, Part-I, Madhu Varga (25); Guduchyadi Varga (114) ; Haritkyadi Varga (197); Guduchyadi Varga

6.

7.

8.

9.

10.

73

(220).10th ed., Vidyotini, hindi commentary by Sri Bhramashankara Mishra and Rupalalji Vaisya , Varanasi, Chaukhambha Bharati Academy2002.

Madhava. Ayurveda Prakasha, (3:152) and (3:153). 4th ed., Arthvidyotini and Arthaprakashini commentary, Varanasi, Chaukhambha Bharati Academy, 1994.

Madhavakara. Madhavanidana, (33:24), pg. 22.

Madhukosha Sanskrit commentary by Shrivijayrakshita and Shrikanthdutta, Varanasi, Chaukhambha Surbharati Prakashan, 2006.

Rasavagbhatta. Rasaratnasamuccaya, Vol.-1, (5:13), pg. 93.Vigyanabodhini commentary by Kulakarni D.A., , New Delhi, Meharchand Lachhmandas Publications 1998.

Sushruta. Sushruta Samhita, ., Nidana Sthana (6:30), Sutra Sthana (45:141). 11th ed., Ayurvedatattva-samdipika commentary by Ambikadutta Shastri, Chaukhambha Sanskrit Sansthan, Varanasi, 2001 Vagbhatta. Ashtang Hridya, , Nidana Sthana (10:18) and (10:21). 9th ed., Sarvangasundara and Ayurvedarasayana commentary, Varanasi, Chaukhambha Surbharti Prakashan, 2005.

Address for correspondence: Dr. B. J. Patgiri, Associate Professor, Department of Rasashastra & Bhaishajya Kalpana including Drug Research, I.P.G.T. & R.A., Gujarat Ayurved University, Jamnagar-361008 Gujarat (India) E-mail: patgiri06@yahoo.co.in JREIM-2012-04-03

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J Res Educ Indian Med, April-June 2014; Vol. XX (2): 75-87

ISSN 0970-7700

FORMULATION DESIGN AND EVALUATION OF ANTI-INFLAMMATORY ACTIVITY OF COMMIPHORA MUKUL LOADED EMULGEL TEJINDER KAUR MARWAHA,1 AND KIRAN S BHISE2 Department of Pharmaceutics, MCE Societyâ&#x20AC;&#x2122;s Allana College of Pharmacy, Azam Campus, Pune - 411 001 Maharashtra (India) Abstract : Background: Commiphora mukul widely known as Guggulu. An ethyl acetate extract of guggul resin, obtained from Commiphora mukul (Fam.: Burseraceae) known as guggulipid is official in Indian Pharmacopoeia 1. The active constituent of gugulipid is guggulsterone which has been found to potently inhibit the activation of nuclear factor-kappaB (NF-kappaB), a critical regulator of inflammatory responses. Commiphora mukul (Guggul extract) was found to be efficacious and cheap anti-inflammatory drug with least side effects. Therefore it was selected for the present study. Objective: Considering the above justification an attempt was made to design and develop herbal anti-inflammatory topical drug delivery system wherein herbal drug in the form of emulgel was formulated and its effect was compared to marketed preparation. Method: In the study, topical emulgel of Commiphora mukul (Guggul extract) was formulated. The optimized batch was evaluated for %EE and %DR followed by in vivo studies. Result: From the in vitro studies, formulation S3 showed maximum release of 77.57 % in 6 hrs. The formulation S3 was comparable with marketed tacrolimus ointment. The results indicated that the optimized batch containing drug Commiphora mukul (Guggul extract) exhibited good results. Conclusion: Thus, the results indicate that an effective biphasic herbal anti inflammatory formulation containing Commiphora mukul (Guggul extract) can be prepared in the form of emulgel.

Keywords : Anti inflammatory, Commiphora mukul, Gugulipid, Emulgel

Introduction Gugulipid is an ethyl acetate extract of guggul resin, obtained from Commiphora mukul (Fam.: Burseraceae) and is official in Indian Pharmacopoeia 1 . The active constituent of gugulipid is guggulsterone (4,17(20)-pregnadiene3,16-dione) , which is present in a concentration of 4.0-6.0%. The guggulsterone is present in guggulipid in the form of stereoisomers Eguggulsterone and Z-guggulsterone. Gugulipid is a potent hypolipidemic agent. Apart from its hypolipidemic activity, a large number of therapeutic activities like antimicrobial, anthelmintic, anti-inflammatory, antiarthritic and antioxidant have been reported 2-4. Guggulsterone has been found to potently inhibit the activation of nuclear factor-kappaB (NF-kappaB), a critical regulator of inflammatory responses. Such 1. M.Pharma Student

2. Principal

repression of NF-kappaB activation by guggulsterone has been proposed as a mechanism of the antiinflammatory effect of guggulsterone 5 A wide range of therapeutic activities, low bioavailability and aqueous insolubility of guggulipid led to explore an approach, which in addition to removing its undesired pharmacological action also improves its therapeutic concentration at the site of inflammation. Tacrolimus ointment is used as a comparator marketed preparation.

Tacrolimus being topical immunosuppressive agent has various side effects in ointment manufacturing as well as several applications after effects. Topical application of anti-inflammatory agents at the site of inflammation can overcome their systemic side effects and improve their therapeutic activity. Guggul has been reported to mix properties of liposome, solid lipid particles

76

Tajender Kaur and Kiran Bhise

and multiple emulsions etc.6,7. Emulgel system was selected as it meets all the criterias laid down for topical drug delivery of guggul.

Emulgels are particularly light weight products with a low emulsifier and lipid content. They are characterized by the fact that they can be distributed readily on the skin and impart a feeling of freshness. Emulgels have emerged as one of the most interesting topical delivery system as it has dual release control system i.e. gel and emulsion 8,9. The aim of the present investigation was to explore the possibilities of using anti inflammatory herbal drug in the topical dosage form and to design and develop biphasic drug delivery system of herbal anti-inflammatory drug in the form of emulgel.

Materials Guggul extract was generously gifted by Kuber Impex Ltd, Indore (M.P). Capryol 90 and Capmul MCM C8 were obtained as gift samples from Gattefosse India Pvt. Ltd. and Abitec Corporation, Mumbai respectively. Cremophor RH 40 was gifted by SigNET AC Limited, UK. Rest of the chemicals used was procured from Loba Chem. Pvt. Ltd., Mumbai, India. 12 wistar albino rats were procured from Yash Farms, Pune, India Methods I. Preformulation Study for Drug and Polymers The samples of Guggul Extract, Oils, Surfactants and Co Surfactants were subjected to the following preformulation studies (I). Characterization of Guggul extract A. Organoleptic Properties10 Guggul extract was analyzed for the organoleptic properties like colour, odour and appearance.

B. Micromeritic Properties11-13 Powdered extract of Gum guggul was evaluated for parameters like Bulk density, Tapped density, Carrâ&#x20AC;&#x2122;s index, Angle of repose, and

Hausner ratio. The observations were recorded in triplicate.

C. Solubility Profile Solubility of Guggul extract was checked visually in distilled water, methanol, ethanol, chloroform, acetone, DMSO and phosphate buffer (pH 5.4). Accurately weighed one gm of drug was transferred in a clean and dry test tube followed by addition of the solvents individually and shaken vigorously and the solubility of drug was checked visually.Determination of solubility in DMSO and phosphate buffer pH 5.4 mixture for determination of ratio: Accurately weighed 20 mg of Guggul extract was added individually to ten clean and dried volumetric flasks each of 10 ml capacity.

DMSO and phosphate buffer pH 5.4 solvent system was added in the ratio 1:9, 2:8, 3:7, 4:6, 5:5, 6:3, 7:3, 8:2, 9:1 and the samples were shaken for 1 hour on linear motion shaker (Model no.

REMI RQ 123, Spectra Whirlmatic Lab,India).

The solutions were checked visually for their clarity.

D. Analytical Methodology14 The ultraviolet absorption spectrum of a solution of Guggul extract in DMSO and (8:2) mixture of DMSO and Phosphate buffer pH 5.4 was obtained using UV/VIS spectrophotometer (V-630, Jasco Corporation Tokyo, Japan) over a wavelength range of 200 to 400 nm. Maximum absorption (ĂŤmax) values were determined and further used for plotting calibration curve.

2.

Characterization of Oil, Surfactant and Co-Surfactant for Microemulsion A. Solubility Determination in various Oil, Surfactant and Co-surfactant15 The solubility of drug in various oils, surfactants and co-surfactants was measured and the solvents for the study were selected based on the good solublising capacity for drug. In present study the solubility of drug was investigated in different oils like Isopropyl myristate, Captex, Capryol 90 etc, surfactants and co-surfactants like Tween 80, Cremophor RH40 etc. An excess amount of drug was added

Anti-inflammatory activity of commiphora mukul loaded emulgel

into each vehicle followed by vortex mixing for 30sec (Remi mixer, Mumbai). Mixtures were shaken for 48 h at 300 C, followed by equilibrium for 24 hr. The equilibrated samples were then centrifuged at 1000 rpm for 10 min to remove the insoluble drug and clear supernatant liquid was decanted. An aliquot of the supernatant was diluted with DMSO and solubility of drug was estimated by UV spectroscopy at 328 nm.

B. Screening of oils and surfactant The oils and surfactants were selected on the basis of theirFigure tendency for instant 7 emulsification. The oils selected for this investigation were Captex, Capryol 90, IPM, Wheatgerm oil, Olive oil and Soyabean oil. The surfactants selected were Cremophor RH-40, Tween 80, Tween 20, Span 80, Span 20, Soya lecithin and Acconon MC8-2. The oils and surfactant were mixed in a ratio of 1:1. Briefly, 150 mg of the surfactants were added to 150 mg of the oily phase. Each mixture, 100 mg, was then diluted with distilled water to 100 ml in a stoppered conical flask. Ease of emulsification was judged by the number of flask inversions required to yield homogenous emulsion.

Emulsions were allowed to stand for 2hr and their % transmittance was evaluated at 638 nm

by UV-Visible spectrophotometer (Jasco V 650, Japan) using distilled water as a blank. Emulsions were furthermore observed visually for any turbidity or phase separation.

C. Preliminary screening of co-surfactants The selected oily phase and surfactant were used for further screening of the different cosurfactants (Ethylene glycol, Propylene glycol, PEG 400, Capmul PG8 and Capmul MCM C8) for their emulsification ability. Mixtures of 200 mg of co-surfactant, 400 mg selected surfactant, and 600 mg screened oil were prepared and evaluated in a similar fashion as described in preliminary screening of surfactants.

D. Pseudo-Ternary Phase iagram:16,17 The microemulsion existence region was determined by constructing pseudo-ternary phase diagrams. Titration method was employed for its determination.

77

On the basis of the solubility study of drug; oils, surfactants, co-surfactants and aqueous phase were used for construction of phase diagram. Surfactant and co-surfactant (Smix) in each group were mixed in different weight ratio of (1:0, 1:1, 1:2, 2:1, 1:3, 3:1, 1:4, 4:1). For each phase diagram oil and specific Smix ratio were mixed thoroughly in different weight ratio from 1:9 to 9:1 (1:9, 2:8, 3:7, 4:6, 5.0:5.0, 6:4, 7:3, 8:2, 9:1,) in different glass vials.

Different combination of oils and Smix were prepared for the study to delineate the boundaries of phase precisely formed in the phase diagrams.

Pseudo-ternary phase diagram was developed using aqueous titration method. Water was added dropwise with constant stirring on 6 Station magnetic stirrer (Spectralab, Whirlmatic, India) until homogeneous dispersion or solution was obtained. After each addition the system was examined for appearance and flow property. The end point of the titration was the point in which the solution becomes cloudy or turbid. The quantity of aqueous phase required to achieve turbidity point was noted. Slow titration with aqueous phase is performed to each weight ratio of oil and Smix. The physical state of the microemulsion was marked on a pseudo-threecomponent phase diagram with one axis representing aqueous phase, the other representing oil and the third representing a mixture of surfactant and co-surfactant at fixed weight ratios (Smix ratio).

(II). Formulation Study A. Formulation of Emulgel The factorial Batches of microemulsion that contained Gum guggul extract was formulated by mixing oil, surfactant and co-surfactant with varying component ratio. Accurately measured 0.15 (% w/v) of Gum Guggul extract was dissolved in the mixture of oil, surfactant and co-surfactant and then an appropriate amount of water was added to the mixture dropwise with constant stirring on 6 station magnetic stirrer (Spectralab, Whirlmatic, India). Microemulsion of Gum Guggul was obtained spontaneously on stirring the mixtures at ambient temperature.

78

Tajender Kaur and Kiran Bhise

Various gelling agents namely, Sodium CMC, Hydroxypropyl methylcellulose (Methocel K4000M), HPMC CR, Carbopol 934 and Carbopol 940 were evaluated for their ability to gel medicated microemulsion. Gelling agent was dispersed slowly in the medicated microemulsion with the help of overhead stirrer. In case of Carbopol 940 and 934, the dispersion was neutralized by using triethanolamine to obtain the gel.

B. Factorial Formulations: The effect of formulation variables on the responses were statically evaluated by applying one-way ANOVA, using the commercially available software package Design-ExpertÂŽ version 8.0. 23 factorial design was implemented for optimization of microemulsion that contained three independent variables at two levels +1 and -1. The factorial batches are given in Table No. 1 and 2.The batches were evaluated and the effect of individual variable was studied according to the response surface methodology.

C. Evaluation of the Factorial Batches Of Microemulsion Based Gel Of Guggul extract.18 1.% EE Accurately weighed 1 mg of gel was mixed in 10 ml calibrated volumetric flasks containing 9 ml DMSO; it was diluted appropriately and drug content was determined spectrophotometrically in triplicate. % EE was calculated as per the formula:

% EE =

Actual drug content - Free drug content X 100 Actual drug content

2.% DR The in vitro drug release studies were carried out using a modified Franz diffusion (FD) cell. Accurately weighed 1gm of sample was applied on cellophane membrane which was placed between donor and receptor compartment of the FD cell. 8:2 mixture of DMSO and

Table 1. 23 Factorial design of Gum guggul Microemulsion:Levels of variables in coded and actual form Variables for Experimental Designs Independent variable: X1= Capryol 90 X2= Cremophor RH 40 X3= Capmul MCM Dependent variable: Y1= % Entrapment efficiency Y2= %Drug release at 6 hr Actual values Levels (Code Value)

Response

X1(% w/v)(Capryol)

X2 (% w/v)( Cremophor)

X3 (% w/v)(Capmul MCM)

-1

0.25

0.25

0.25

+1

0.5

0.5

0.5

Y1

Y2

% Entrapment Efficiency

% Drug Release

Table 2. Composition of Factorial batches of Gum guggul Microemulsion Based Gel with C940 as Gelling Agent Ingredients Sr. No

Formulation Code

1

C mukul (%) (w/v)

Capryol (%) (v/v)

Cremophor RH 40 (%) (v/v)

Cap MCM (%) (v/v)

Water (%) (v/v)

S1

0.15

0.25

0.25

0.25

Upto 100

2

S2

0.15

0.5

0.25

0.25

Upto 100

3

S3

0.15

0.25

0.5

0.25

Upto 100

4

S4

0.15

0.25

0.25

0.5

Upto 100

5

S5

0.15

0.5

0.5

0.25

Upto 100

6

S6

0.15

0.25

0.5

0.5

Upto 100

7

S7

0.15

0.5

0.25

0.5

Upto 100

8

S8

0.15

0.5

0.5

0.5

Upto 100

Anti-inflammatory activity of commiphora mukul loaded emulgel

Phosphate buffer pH 5.4 was used as a dissolution media. This whole assembly was kept on a magnetic stirrer and the solution was stirred continuously using a magnetic bead. Accurately weighed 1gm of drug containing gel was placed in the donor compartment. Samples (0.5ml) were withdrawn from the receptor fluid at 1 hr interval for upto 6 hrs after the application. An equal volume of the fresh phosphate buffer was immediately replenished after each sampling maintaining sink conditions. The temperature was maintained at 37 ± 0.5 °C with constant rotation speed of 100 rpm. Samples were analyzed by UV-visible spectrophotometer (Jasco, V630) at 328 nm with suitable dilutions and the cumulative % drug release was calculated.

D. Formulation of the Optimised Batch: The optimised batch was formulated using the predicted values of the %EE and %DR from the software.

E. Evaluation of Optimised Batch Containing Guggul extract Microemulsion Based Gel: The optimized gels were evaluated for %EE and %DR. F. Skin irritation test (patch test): Three rats was used in the study. The emulgel was applied on the properly shaven skin of rat. Undesirable skin changes, i.e., change in color, change in skin morphology were checked for a period of 24 hr.

(III). In Vivo Anti-Inflammatory Activity for Optimised Batches of Gum guggul, Babchi Oil and Combined Microemulsion Based Gel19 Wistar albino rats of either sex, weighing 150-210gm were used for the experiment.

Animals were housed in standard cages in lightcontrolled room at 25 ± 3° (12 hour light/ 12 hour dark cycle and 50 ± 5 % RH, were given standard pellet diet and water ad libitum. All experiments were performed after an overnight fast. All studies were conducted in accordance with protocols, reviewed and approved by the Institutional Animal Ethics Committee (IAEC) of

79

Allana College of Pharmacy, Pune, Maharashtra, India. The serial number of the approval protocol was Ref/ ACP/ IAEC/11-12/29-02 for in vivo anti inflammatory studies.

In order to establish anti inflammatory activity edema was induced on the left hind paw of the rats by subplantar injection of 1% (w/v) carrageenan. Formulation, i.e., S3 and standard (tacrolimus ointment) were applied 30 min before carrageenan administration. The paw volume was measured at intervals of 30, 60, 90, 120 min by mercury displacement method using plethysmometer Group 1 (Control group): Carrageenan (1%).

Group 2 (Standard group): Topical marketed Tacrolimus gel + Carrageenan.

Group 3 (Test): Formulations S3 + Carrageenan.

The % inhibition of paw edema in drug treated group was compared with carrageenan control group and calculated according to the formula: % Inhibition =

Control paw volume – Test paw volume X 100

Control paw volume

Accelerated Stability Studies20 The stability studies were carried out according to the ICH guidelines to assess the drug and formulation stability. The optimized formulations were sealed in aluminum packaging material. Samples were kept in a stability chamber (Thermolab) maintained at 45 ºC and 75 % RH for 3 months. The samples were withdrawn at 0, 1, 2 and 3 months.

IV.

Evaluation The optimized formulations were evaluated over a period of 3 months for the following parameters: Appearance, pH, %EE, in vitro Dissolution study.

Results and Discussion (I).

Preformulation Studies 1.Characterization of Gum guggul: A. Physical appearance: The drug was subjected to organoleptic evaluation.

80

Tajender Kaur and Kiran Bhise

The results obtained are shown in Table 3.

Table 3. Organoleptic Properties of Gum guggul Sr. No.

Parameters

Gum guggul

1.

Methanol

Sparingly Soluble

3.

Ethanol

Sparingly Soluble

4.

Chloroform

Sparingly Soluble

5.

Acetone

Sparingly Soluble

Odour

Acrid

Acrid

3.

Taste

Bitter

Bitter

Organoleptic properties obtained practically matches the properties given in the literature.

Thus it conforms the identity of the drug.

B. Micromeritic Properties The results of evaluation of micromeritic properties of the drug are depicted in Table 4.

Table 4. Micromeritic Properties of Gum guggul Observation

Result (Mean)

0.58 0.58

0.5733

0.56 0.7407 2.

Tap density (gm/cm3)

3.

Hausner ratio

4.

Compressibility index

0.7692

0.7502

0.7407 1.308

1.308

23.58%

23.58%

36.02 5.

Angle of repose

Insoluble

2.

2.

1.

Distilled Water

Solubility

Slight yellow

Colour

Bulk density (gm/cm3)

Solvent

Theoretical

1.

Parameters

No.

Experimental

Slight yellow

Sr. No.

Table 5. Solubility Profile of Gum guggul extract

35.05

35.69

36.02

The results obtained from Table No.4 exhibited that the drug had Hausner ratio within 1.26-1.34, % Compressibility within the range of 23%-28% and Angle of repose within the range of 30-40 with passable to poor flow property.

C. Solubility Profile Solubility of powdered extract of Gum guggul is depicted in Table 5.

6.

DMSO

7.

Phosphate Buffer (5.4 pH)

Soluble Sparingly Soluble

It can be depicted from Table 5 that Gum guggul is soluble in DMSO, thus DMSO was selected for further studies.

D. Analytical Methodology UV-Visible Spectroscopy261 The gama max of Gum guggul in DMSO and (8:2) mixture of DMSO: Phosphate buffer pH 5.4 was found to be 328 nm, 329nm respectively.

2.

Characterization of Oil,Surfactant and Co-Surfactant A. Selection of Excipients The excipients selected needed to be pharmaceutically acceptable, nonirritating, and nonsensitizing to the skin and to fall into the GRAS (generally regarded as safe) category.

Higher solubility of the drug in the oil phase was another important criterion, as it would help the microemulsion to maintain the drug in solubilized form. Safety is a major determining factor in choosing a surfactant, as a large amount of surfactants may cause skin irritation. Non-ionic surfactants are less toxic than ionic surfactants.

An important criterion for selection of the surfactants is that the required hydrophilic lipophilic balance (HLB) value to form the o/w microemulsion be greater than 10. The right blend of low and high HLB surfactants leads to the formation of a stable microemulsion formulation.

In this study, we selected Cremophor RH 40 as a surfactant with an HLB value of 15. Transient negative interfacial tension and fluid interfacial

Anti-inflammatory activity of commiphora mukul loaded emulgel

film are rarely achieved by the use of single surfactant; usually, addition of a cosurfactant is necessary. The presence of cosurfactant decreases the bending stress of interface and allows the interfacial film sufficient flexibility to take up different curvatures required to form microemulsions over a wide range of composition. Thus, the cosurfactant selected for the study was Capmul MCM, which has an HLB value of 5-6. Gum guggul is a highly lipophilic drug, and its pharmacological properties suggest that it has good potential for topical drug delivery.

It can be depicted from the above Table No.6 that in oils, Capryol 90, in surfactants Cremophor RH 40 and in Co-Surfactants Capmul MCM has better solubility with the drug as compared to others. Therefore on the basis of solubility data polymers were selected for formulations.

B. Pseudo-Ternary Phase Diagram a)Ternary diagram of Ratio of Oil to Smix Oil = Captex Smix = Cremophor : Capmul MCM (2:1)

81

Fig. 1. Ternary Diagram of Ratio of Oil (Capryol) to Smix (Cremophor : Capmul MCM (2:1))

Thus from the ternary diagram in Fig.1, it can be concluded that best ratios of Oil:Smix that gives microemulsion region are 5:5, 4:6. b) Selection of Surfactant and Co Surfactant Ternary diagram of different concentration of surfactant and co-surfactant are given in Fig.2 From the ternary diagrams it is depicted that Cremophor (surfactant) and Capmul MCM (co-surfactant) with Capryol as oil gives the maximum microemulsion region.

Phase behavior investigation of this system demonstrated the suitable approach to determining the water phase, oil phase, surfactant

Fig. 2. Ternary Diagram of (i) Oil – Captex, Surfactant – Tween, Co-surfactant – Capmul PG8 (ii) Oil – Capryol, Surfactant – Tween, Co-surfactant – Capmul MCM (iii) Oil – Capryol, Surfactant – Cremophor, Co-surfactant – Capmul MCM (iv) Oil – Olive oil, Surfactant – Tween, Co-surfactant – Capmul PG8

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Tajender Kaur and Kiran Bhise

Table 6. Solubility Determination of Gum guggul in Various Oil, Surfactant and Co-surfactant Sr. No.

1.

2.

3.

Solubility (Âľg/ml) In

Solvent

Gum guggul

Captex

62.2

Wheatgerm Oil

25.5

Olive Oil

24.2

Capryol 90

65.6

Soyabean Oil

32.8

IPM

3.7

Oil

Cremophor RH-40

70.5

Tween 80

139.4

Acconon MC8-2

45.7

Surfactant

Ethylene Glycol

50.2

Propylene Glycol

56.2

Co-surfactant

PEG 400

38.9

Capmul MCM C-10

55.7

Capmul PG8

49.2

(II). Formulation Study G. Factorial Batches of Gum guggul extract Microemulsion Formulated with C940 as Gelling Agent . .

Fig. 3: Linear Correlation Plot between Actual and Predicted Values for % EE (Y1)

concentration, and cosurfactant concentration with which the transparent, 1-phase low-viscous microemulsion system was formed. The phase study revealed that the maximum proportion of oil was incorporated in microemulsion systems when the surfactant-to-cosurfactant ratio was 5:5. From pseudoternary phase diagrams, the formulation in which the amounts of oil phase completely solubilized the drug and which could accommodate the optimum quantity of Smix and distilled water was selected for the study.

Fig. 4: Response surface plot showing effect of formulation variables on % EE (Y1)

Fig.4 showed the response surface plot, which displayed the effect of X1, X2 and X3 on the %EE Y1. From the figure, at maximum level of X2 (0.5), and minimum levels of X1, X3 (0.25) results in increasing the %EE of the formulation to the maximum 94. On the other hand, increasing X1, X2 up to (0.5) and decreasing X3 to (0.25)

Anti-inflammatory activity of commiphora mukul loaded emulgel

83

results in decreasing the %EE to the minimum 91.

Also, it was found that, high level of X1 (0.5) and low levels of X2 and X3 (0.25) resulted in high value of %EE. The %EE of the formulation will be maximized either at low 0.25 or high 0.5 of X2, where %EE of the formulation was 93 and 94.

Fig. 7. Response surface plot showing effect of formulation variables on % DR (Y2)

Fig.5: Contour plot showing the effect of X1, X2 and X3 on % EE (Y1)

Contour plot represented in Fig.5 gave an idea about the exact percent of X1, X2 and X3 at which the %EE becomes at minimum level.

Fig. 7 showed the response surface plot, which displayed the effect of X1, X2 and X3 on the %DR Y2. From the figure, at maximum level of X2 (0.5), and minimum levels of X1, X3 (0.25) results in increasing the %DR of the formulation to the maximum 77. On the other hand, increasing X1, X2 up to (0.5) and decreasing X3 to (0.25) results in decreasing the %DR to the minimum 75. Also, it was found that, high level of X1 (0.5) and low levels of X2 and X3 (0.25) resulted in high values of %DR. The %DR of the formulation will be maximized either at low 0.25 or high 0.5 of X2, where %DR of the formulation was 76 and 77.

Contour plot represented in Fig. 8 gave an idea about the exact percent of X1, X2 and X3 at which the %DR becomes at minimum level. Fig. 6 showed the linear correlation plot of predicted and actual values of %DR and these values are near by each other indicating the correctness of the model.

Fig. 6. Linear Correlation Plot between Actual and Predicted Values for % DR (Y2)

Fig.6 showed the linear correlation plot of predicted and actual values of %EE and these values are near by each other indicating the correctness of the model.

H. Evaluation of the Factorial Batches of Microemulsion that contained Gum guggul extract Based Gel From Fig.9 it can be concluded that Batch S3 showed good drug release as compared to other batches thus it was selected as an optimized batch.

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Tajender Kaur and Kiran Bhise

Table 7. Factorial batches that Contained Gum guggul extract Microemulsion with C940 as Gelling Agent Parameter/ Batch /Code

%EE

% DR at 6 hrs

S1

91.71±1.68

76.285±0.26

S2

93.12±1.63

76.772±0.17

S3

94.05±0.25

77.574±0.21

S4

90.62±2.07

76.976±0.15

S5

92.82±1.19

74.661±0.14

S6

94.03±1.14

76.984±0.01

S7

90.49±0.13

75.617±0.03

S8

89.95±0.34

73.783±0.31

The evaluation results of factorial batches are depicted in Table No. 7. Batch S3 showed promising results.

Fig. 9: Diffusion Graphs of Factorial batches of Gum guggul Microemulsion with C 940 as Gelling Agent

I. Formulation of the Optimised Batch: The optimised batch was formulated using the predicted values of the %EE and %DR from the software and is exhibited in Table 8.

J. Evaluation of Optimised Batch of Gum guggul extract Microemulsion Based Gel: Fig. 10 exhibits drug release of optimised batch S3. From Table 9, it can be concluded that since the experimental and predicted results obtained were found to be nearly same for batches with above mentioned composition, it

.

Fig.8: Contour plot showing the effect of X1, X2 and X3 on % DR (Y2)

Table 8. Formulation of optimised batch that Contained Gum guggul extract Microemulsion Based Gel Formu lation Code

Ingredients Gum guggul (%) (v/v)

Capryol(%) (v/v)

Cremophor RH 40(%) (v/v)

Cap MCM(%) (v/v)

Water(%) (v/v)

0.15

0.25

0.5

0.25

Upto 100

S3

Table 9. Comparison between the Experimented and Predicted Values for Probable Optimal Formulation Dependent variables

Optimized formulation S3 *Experimented value

Most Predicted value

% Drug Release

77.574 ±0.21

76.734

% Entrapment Efficiency

94.05±0.25

94.25

was subjected to stability study as per ICH guidelines The optimized batches showed similar release profile compared to factorial batches.

Release shown was 77.574 ±0.21 Gum guggul in 6 hrs and the best fit model was found to be Higuchi.

Anti-inflammatory activity of commiphora mukul loaded emulgel

85

Before

Fig. 10: Diffusion Graphs of Optimised Batch

K. Skin irritation test (patch test): From Fig. 11 it can be depicted that no allergic symptoms like inflammation, redness, irritation appeared on rats up to 24 h. The results indicated that the control preparation (which did not contain any drug), test gel and marketed products did not cause any skin reaction. It can be assured that drug and the excipients did not cause any skin irritation and can be used in the gel formulation.

(III). In Vivo Anti-Inflammatory Activity For Optimised Batches Of Gum guggul Microemulsion Based Gel Percentage increase in paw volume (inflammation) and percentage inhibition of inflammation in control group and groups treated with test and marketed products and the results are given in the Table 10 and Fig. 12.

In control group which received carrageenan alone, a rapid and continuous increase in paw volume (i.e. inflammation) was observed

A

B

After 24 Hours

Fig. 11: Skin Irritation test on Rats before and after 24hrs

and the inflammation was sustained during the entire period of 6 hrs of study.

In the groups which received test products, the percentage increase in paw volume was low when compared to the control group, indicating that the test and marketed product possess good anti-inflammatory activity. The inflammation due to carrageenan was markedly inhibited by the test and marketed products. A comparison of the percentage inhibition of inflammation (i.e., anti-

C

Fig. 12: Rat Paw Edema Test, results after 6hrs [ (a) Inhibitory Effect of Optimised Batch S3 of Gum guggul MBG ( b) Inhibitory Effect of Marketed formulation (Tacrolimus Ointment) (c)Carrageenan Induced Inflammation]

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Tajender Kaur and Kiran Bhise

Table 10. Mean Paw Edema Volume and Percentage Inhibition of the Edema in the Albino Rats Mean Paw Edema Volume

Time (in chrs)

Percentage Inhibition of the Edema

Control

Test

Standard

Control

Test

Standard

0 1 2 3 4

0.224 0.258 0.279 0.332

0.220 0.198 0.130 0.125

0.225 0.193 0.113 0.107

-

21.46 22.21 68.85 64.37

21.37 25.55 59.85 68.06

0.364

-

67.32

72.66

5 6

0.112 0.105 0.112

0.098

0.392 0.428

0.102 0.108

-

72.19 73.22

73.70 74.51

Table 11. Stability study of optimised batch S3

Parameters

Formulation code S3 Initial

1 month

2 months

3 months

Visual appearance

No Change

No Change

No Change

No Change

pH

5.52

5.50

5.50

5.49

%EE

94.05±0.25

93.46±0.21

93.35±1.33

93.05±1.27

Cumulative% DR

77.574±0.21

77.152±0.591

76.953±0.119

76.034±0.84

inflammatory activity) of test and marketed products is made in Table 10.

The % inhibition of Tacrolimus (marketed preparation) and Test formulations were found to be 74.51% and 73.22% respectively. The pharmacological activity (anti-inflammatory) of optimized batch containing the drug Gum guggul was comparable to the marketed preparation; these results indicated the rapid onset of action and higher activity during the initial periods due to their enhanced dissolution and absorption rates.

Acknowledgement: Author would like to express sincere thank to Pukhraj Herbals, Indore, India for providing Commiphora mukul (Gum guggul) as a gift sample. I also thank to Abitec Corporation, Mumbai; Gattefosse India Pvt. Ltd., Mumbai and SigNET, UK Toyoma, Japan for providing Capmul MCM C8, Capryol 90 and Cremophor RH 40.

1.

(IV). Accelerated Stability Study From Table 11 it can be concluded that all the prepared emulgel formulations were found to be stable upon storage for 3 months.

2.

Conclusion Thus, the results indicate that an effective biphasic herbal formulation containing Gum guggul extract can be prepared in emulgel system and it gave promising results.

5.

3.

4.

References Indian Pharmacopoeia, Vol. II, p. A 74, Govt. of India, Ministry of Health and Family Welfare, Controller of publication, New Delhi 1996.

Chander R., Khanna A.K., Kapoor N.K.: Phytother. Res. 10, 508 (1996).

Beg M., Singhal K.C., Afzaal S.: Indian J. Physiol.

Pharmacol. 40, 237 (1996).

Kimura I., Yoshikawa M., Kobayashi S.:Bioorg.

Med. Chem. Lett. 11, 985 (2001).

Shishodia S, Aggarwal BB. Guggulsterone inhibits NF-kappaB and IkappaBalpha kinase activation, suppresses expression of anti-apoptotic gene products, and enhances apoptosis. J Biol Chem.

2004 Nov 5;279(45):47148-58. Epub 2004 Aug 17.

Anti-inflammatory activity of commiphora mukul loaded emulgel 6.

7.

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10.

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Gupta V B, “Drug Delivery and allied Applications of Guggul” Indian Patent, Application No. 1715/DEL/2004.

Jain A, Gupta VB. Chemistry and Pharmacological profile of guggul- a review. Indian Journal of Traditional Knowledge:5,478-483(2006) Shekhar Verma, Anurekha Jain and V. B. Gupta.

Synergistic and Sustained Anti - Inflammatory Activity of Guguul with the Ibuprofen: A P r e l i m i n a r y Study. International Journal of Pharma and Bio Sciences, Volume 1, Issue 2, 2010 (April–June) Khullar R, Saini S, Sethi N et al. Emulgel A surrogate approach for topically used hydrophobic drugs. Int J Pharm Biol Sci 2011; 117-128 Mohamed MI. Topical emulsion gel composition comprising diclofenac sodium. AAPS J 2004; 6(3):26 United State Pharmacopoeia – NF, volume 1, asian edition 2007, page no. 242-243 CVS Subrahmanyam, Micromeritics: Text book of physical pharmaceutics, second edition 2009, page no. 223-224 D. A. Bhagwat, S Kawtikwar, Dinesh M Sakarkar. sustained release matrices of verapamil hcl using glyceryl monosterate and stearic acid research J. Pharm. and Tech. Dec2008;1(4):p.405-409.

Aulton M.E., Pharmaceutics, The science of dosage form design, 2nd edition, Churchill Livingstone, London, 2002; 15 – 42, 113 – 138, 234 – 252.

Kalsi P S. Spectroscopy of organic compounds.

New Age International publication. NewDelhi 2004; 6th Edition, 20-22.

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17.

18.

19.

20.

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Divyakumar Bora, Priyanka Borude, Kiran Bhise*.

Formulation And Evaluation Of Self Microemulsifying Drug Delivery Systems Of Low Solubility Drug For Enhanced Solubility And Dissolution. International Journal of Pharmaceutical Innovation.

Gupta A.K.*, Mishra D.K. and Mahajan S.C.Preparation And In-Vitro Evaluation Of Self Emulsifying Drug Delivery System Of Antihypertensive Drug Valsartan. Int. J. of Pharm. & Life Sci. (IJPLS), Vol. 2, Issue 3: March: 2011, 633-639 Bonacucina, G., Cespi, M., Palmieri, G.F., 2009.

Characterization and Stability of Emulsion Gels Based On Acrylamide/Sodium Acryloyldimethyl Taurate Copolymer. AAPS PharmSciTech. 2, 10.

Crunkhorn, P., Mencock, S.C., 1971. Mediators of inflammation induced in rat paw carregeenan.

Br. J. Pharmacol. 42, 371–402.

ICH Harmonized Tripartite Guidelines, Stability Testing of New Drug Substances and Products.

ICH Committee 2003; 8.

Abbreviation DMSO - Di Methyl Sulphoxide HLB - Hydrophilic Lipophilic Balance %DR - Percent Drug Release %EE - Percent Entrapment Efficiency Smix - Surfactant and Co-surfactant Mixture

Address for correspondence: Tejinder Kaur Marwaha, M.Pharma Scholar, Department of Pharmaceutics, MCE Society’s Allana College of Pharmacy, Azam Campus, Pune - 411 001 Maharashtra (India) Email: tej.kaur20@gmail.com JREIM 2012-12-038

82-1355812130

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ISSN : 0970-7700 (Print)

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J Res Educ Indian Med, April-June, 2014; Vol. XX (2):89-93

ISSN 0970-7700

EFFECTIVENESS OF MINDFULNESS BSED COGNITIVE THERAPY ON ANXIETY, STRESS AND DEPRESSION OF PREGNANT YOUTHS: A RANDOMIZED CLINICAL TRIAL SEYED KHADIJEH SEYED MUSAVI,1* AND MOHAMMAD NARIMANI 2 Department of Psychology,1 Islamic Azad University Branch of Ardebil- Basij-Ardebil (Iran) Department of Psychology,2 Mohaghegh University of Ardebil- Daneshgha St-Ardebil (Iran) Abstract: Introduction: Pregnancy in adolescence could be risky and planning supportive programs is critical for pregnant youths. Therefore, this study aimed to explore the effectiveness of cognitive therapy (based on mindfulness) on the reduction of anxiety, stress and depression among pregnant woman younger than 20 years of age. Material and Methods: This study employed pre-post-test method with control group. The study population included all pregnant women of Ardebil who was below 20 years of age and who reported higher than normal level scores in anxiety, stress or depression during 2013. The selected sample comprised 30 youth pregnant females below 20 years age. They were selected by convenience method from health care centers of Ardebil, and assigned randomly in control and experimental group. The data collected by standard anxiety, stress and depression questionnaire and trait anxiety. The collected data analyzed

by Multiple Analysis of Variance (MANOVA). Results: The result of MANOVA revealed that mindfulness based cognitive therapy significantly is effective on stress [F (1,29) = 57.58 p < .0005], anxiety [F (1,29) = 57.58 p < .0005 ] and depression [F (1,29) = 79.52 p < .0005] of pregnant women who aged below 20 years. Conclusion: According to the findings of this study and other relevant studies as pregnancy is a very sensitive stage of every womanâ&#x20AC;&#x2122;s life and they need proper care. The authors suggest to future researchers to design and explore MBCT based on pregnancy condition associated problems.

Keywords: Teasdale cognitive therapy; Anxiety; Stress; Depression; Pregnancy

Introduction Pregnancy is described as a critical period of a female life. Pregnant women are usually involved to some symptom such as helplessness, anxiety, confusion, depression, psychosomatic symptoms, anger, sense of inefficacy, suicidal ideation, hopelessness and restlessness (Zolfeghari, and Asadi Noghabi, 2010).[1] According to professional suggestions, 21-28 years old are the best ages of fertility that human uterus has completely developed. Very young mother who are below 2 years old usually have an insufficient level of hormones and it could lead to mortality among newborn infants of them.

Research showed that the motherâ&#x20AC;&#x2122;s age is not the only explanation for infant mortality among babies of teenage mothers rather, meanwhile majorities of pregnant teenagers come from poor 1. PG Student

2. Professor

families with stress, nourishment and health relate problems (Archk et al,2007). [2] Emotional problems also could make the situation worst. If a pregnant woman experience stress, anxiety and depression, the child may be affected and some psychological, physical, economic and social problems could be emerge consequently.

Severe stress is associated with abortion, premature birth, low weight, breath diseases, digestive diseases and physical problems such as cleft lip and palate, pyloric stenosis (Van den Berg et al, 2007).[3] Considering the known and unknown side effects of psychiatric medicine for pregnant woman, it is recommended that using non-pharmacological methods like psychological treatments to cure anxiety, stress and depression of pregnant women is more safe and secure. In last decade efficacy of several

90

Seyed Khadijeh Seyed Musavi and Mohammad Narimani

psychotherapy methods has been examined on pregnant woman’s psychiatric problems such as CBT, yoga, meditation etc.(Kendall-Tackett, 2010),[4] (Kendall-Tackett, 2008),[5] (Arch et al, 2012).[6] Regarding recently the acceptance based therapies emerged with high promising results and medium to large efficacy during short time treatments. In this research, we used MBCT method, a combination of Beck cognitive therapy and Kabat zinn’s mindfulness-based stress reduction program (Kaviani et a, 2004). [7] Mindfulness is not only a technique, it is a method of being or a method of understanding that requires the perception of personal feelings. The therapy usually includes a variety of medicines, stretching yoga, a primitive education about depression, body scanning exercise and a couple of hours practicing cognitive therapy that shows the relationship between mood, thoughts, feelings and bodily senses (Veiten et al, 2008).[8] Lots of research has shown the effectiveness of this therapy. For example, Teasdel et al.,(1995) have trained 145 healed patients with depression by MBCT method.

Results showed that the relapse rate of the patients was 40 percent while the rate for the patients who did not receive the training was 66 percent (Teasdale et al, 1995).[9] In another study, Ma and Teasdel (2004)[10] examined the effectiveness of MBCT in comparison to usual care. He reported that MBCT reduced relapse from 78% to 36% in 55 patients with 3 or more previous episodes; but in 18 patients with only 2 (recent) episodes corresponding figures were 20% and 50%. MBCT was most effective in preventing relapses not preceded by life events (Ma and Teasdale, 2004).[10] There is a lack of knowledge about third view of psychotherapies in developing countries as Iran so no study has been examined the efficacy of mindfulness-based interventions in pregnant woman especially in youths. Therefore we aimed to examine the efficacy of MBCT on depression, anxiety and stress of under 20 year age pregnant youths.

2. Method This research was a pre-test and post-test experimental design with experimental and control groups.

2.1 Sampling Statistical population included all the of pregnant youths younger than 20 age years old who referred to women’s health centers of Ardebil-Iran to receive pre-birth health services in 2013. At the first phase, the groups filed anxiety, stress and depression questionnaire of Lovibond & Lovibond (1995)[11] and state-trait anxiety questionnaire of Spilburger (1970). The final sample includes 30 pregnant youth females who got high scores in depression, anxiety and stress scale (DASS21) Lovibond & Lovibond (1995) [11] and signed the consent form to participating in this study. Then they randomly divided to the control (N=15) and intervention (N=15) groups, 15 participants each group. The intervention groups received MBCT treatment and the control group received no intervention during the study.

2.2 Tools State-trait anxiety questionnaire The questionnaire was invented by Spilburger and others (1970)[12] and comprised 40 items and two scales of state (explicit) and trait (implicit) anxiety. This scale—widely used in pregnant females and showed to be predictive for higher fetal heart rate reactivity, greater uterine artery resistance, preeclampsia and gestational age at birth. Spilburger and other reported alpha coefficient of 0.90 and 0.92 for state and trait anxiety respectively. Test-retest reliability for state anxiety is reported to be 0.16 to 0.62 and for trait anxiety 0.73 to 0.86 (Spielberger et al, 1970).[12] Depression, anxiety and stress scale (DASS21) Lovibond & Lovibond invent this scale, 1995 and consisted 21 items, which answered through Likert scale. This tool measures anxiety,

Cognitive therapy on anxiety, stress and depression in pregnant youths

stress and depression. Beyond investigations of factor structure or dimensionality, studies have reported good estimates of internal consistency reliability for the original scale scores (range= 0.82 to 0.97) of the DASS-21 in clinical and nonclinical samples (Osman et al, 2012)[13]; Lovibond and Lovibond, 1995).[11] 2.3 Intervention The intervention included standard 8 session of MBCT according to the plan proposed

by Kabat-zinn,1990.[14] 2.4 Statistical Analysis SPSS version 20 was used for analyzing the gathered data. Descriptive analysis comprised mean, standard deviation, percentage and frequency. MANCOVA used to test the significance difference of outcome between-group differences in change from pre-intervention to post-intervention.

3. Results 3.1 Descriptive The results showed 47% of the participants in the experimental group and 33% of the control group were 16 to 17 years old. Also 53% of the

91

control group and 67% of the control group were 17-19 years old.

3.2 Comparative results (Table-1) Comparing trait anxiety scores of control and experimental groups also showed significant differences. The experiment or treatment group had a lower trait anxiety.

Comparing mean scores and MANCOVA results F (1,29) = 7.94 p < .0005 of the treatment and control groups showed that state anxiety of the treatment group was significantly lower than experiment group.

The results of MANOVA showed that F (1,29) = 57.58 p < .0005 of score of stress in treatment group was considerably lower than control group (Table 1).

As the table shows, the depression means scores and MANCOVA results [F (1, 29) = 5.81 p <.0005] of the treatment group were significantly lower than the scores of the control group. Therefore, MBCT intervention decreased the stress levels of participants in the treatment group.

As the table shows, the depression means scores and MANCOVA results [F (1, 29) = 79.52 p <.0005] of the treatment group were

Table 1. Results of MANOVA analysis to compare depression, stress and anxiety levels of the groups

Model Depression

Stress

Control-experiment

Df

Mean of squares

F

P

47485.49

1

47485.49

828.41

0.001

789.98

1

789.98

137.69

0.001

Pre-test and post-test

2586.21

1

2586.21

45.11

0.001

Control*

4558.42

1

4558.42

79.52

0.001

Model

30656.45

1

30654.45

2227.07

0.001

Control-experiment

92.45

1

92.45

6.71

0.001

Pre-test and post-test

125

1

125

9.08

0.001

Control*

80

1

80

5.81

0.001

116926.61

1

116926.61

480.16

0.001

Control-experiment

6122.64

1

6122.64

25.14

0.001

Pre-test and post-test

1955.05

1

1955.05

8.02

0.001

Control*

1934.98

1

1934.98

7.94

0.001

Model Anxiety

Sum of squares

* Control *experiment with pre-test and post-test

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Seyed Khadijeh Seyed Musavi and Mohammad Narimani

significantly lower than the scores of the control group. Therefore, MBCT intervention decreased the depression levels of participants in the treatment group.

Discussion and Conclusion It appears that a MBCT is a feasible and acceptable treatment of anxiety, stress and depression among young pregnant females since the study participated and completed the MBCT program reported significant reduction in outcome variables in compare to the control group. As Teasdale, Segal, Williams [9] and Ma and Teasdale[10] reported the effectiveness of MBCT on depression, in study done by Ree & Craigiea (2007) also MBCT based treatment decreased depression, anxiety and ineffective attitudes.

Mindfulness based cognitive treatment also effected the anxiety disorder. The authors used DASS like present study to evaluate 26 psychiatric outpatients with mood and/or anxiety disorders.

Results from both completer and intent to treat analyses showed that MBCT lead to significant improvements in depression, anxiety, and stress (Reea and Craigiea, 2007).[15] Kabat-zinn also reported that a majority of subjects participating in mindfulness- based treatment experienced a decrease in psychological and physical symptoms and also acquired major and positive changes in attitudes, behaviour and perception towards themselves, the others and surrounding world.

These finding approved by other researchers (Baer,2003).[16] To explain the findings of present study several reasons can be offered like following: MBCT encourages clients to pay attention to their internal manifestations of ongoing experiences so that they could get some awareness and acceptance toward them. This could decrease reactivity to internal experiences as causes and products of explicit reactions.

MBCT tries to get clients to here and now so that they could be detached from the past and future (Brown and Ryan).[17] They discover through observing thoughts that everything is impermanent and there is no need to worry or

fear from thoughts. This detachment helps them to let the thoughts go without ruminating or magnification of unhelpful thoughts.

Number researches (Baer, 2003), [16] (Brown & Ryan, 2003),[17] (Evans et al. 2008) [18] showed that depression symptoms could be alleviated through MBCT. The MBCT model includes different meditations, Yoga, an introductive training to depression, body scanning exercises, and some cognitive exercises that show relationships between mood, thoughts, feelings and bodily senses. The exercises make it possible to pay attention to ongoing bodily and environmental situations so that reduces the depress genic automatic processes. Totally, research showed that MCBT psychotherapy could significantly decrease state and trait anxiety, stress, anxiety and depression symptoms of under 20 year old mothers. So the method could be efficiently applicable in health centers related to pregnancy health care. This suggested to future studies to conduct intervention in the greater sample size and compare the individual with group sessions.

1.

2.

3.

4.

5.

6.

References M. Zolfeghari, A. and Asadi Noghabi. Nursing and health for mothers and newborns. Tehran, Bashari publications, 2010. 84-96 P.Arck, P.J. Hansen, B.Mulac Jericevic, M.P.Piccinni and J.Szekeres-Bartho.

Progesterone during pregnancy: endocrine-immune cross talk in mammalian species and the role of stress. Am J Reprod Immunol. 2007;58-3: 268-79 M.van den Berg, D.R. Timmermans1, J.H.Kleinveld, J.T. van Eijk, D.L. Knol, G.van der Wal and J.M.van Vugt. Are counsellorsâ&#x20AC;&#x2122; attitudes influencing pregnant womenâ&#x20AC;&#x2122;s attitudes and decisions on prenatal screening?. Prenat Diagn.

2007;27(6):518-24 K.A.Kendall-Tackett. Depression in new mothers, 2nd Edition. London: Routledge. 2010.

P 43.

K.A.Kendall-Tackett. Non-pharmacologic treatments for depression in new mothers.

Amarillo, TX: Hale Publishing. 2008. P 65.

J.J.Arch, S.Dimidjian and C.Chessick. Are exposure-based cognitive behavioral therapies safe

Cognitive therapy on anxiety, stress and depression in pregnant youths

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during pregnancy?. .Arch Womens Ment Health.

2012;15(6):445-57 H.Kaviani, F.Javaheri and H.Bahirayi. The efficacy of mindfulness based cognitive therapy in the reduction of depression related automatic and unhelpful thoughts; 60 days to follow up.

Adv Cogn Sci. 2004;1-7:49-59 C.Vieten, J,Astin. Effects of a mindfulness-based intervention during pregnancy on prenatal stress and mood: results of a pilot study. Arch Womens Ment Health. 2008 ;11: 67–74 J.D.Teasdale, Z.Segal and J.M.Williams. How does cognitive therapy prevent relapse and why should attentional control (mindfulness) training help? Behav Res Ther.1995; 33: 225–39 S.H.Ma and J.D.Teasdale. Mindfulness-based cognitive therapy for depression: replication and exploration of differential relapse prevention effects. J.Consult Clin Psychol. 2004 ;72(1):3140 S.H. Lovibond and P.F.Lovibond. Manual for the Depression Anxiety Stress Scales. Sydney: Psychology Foundation.1995. 1-42.

C.Spielberger, R.Gorsuch and R.Lushene.

Manual for State-Trait Anxiety Inventory. Palo

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Alto, CA: Consulting Psychologist Press. 1970.

1-69 A.Osman, J.L.Wong , C.L.Bagge, S. Freedenthal, P.M.Gutierrez and G.Lozano. The Depression Anxiety Stress Scales—21 (DASS21): Further Examination of Dimensions, Scale Reliability, and Correlates. J Clin Psy. 2012; 68(12): 1322–38 Kabat-Zinn, J. Full catastrophe living: using the wisdom of your body and mind to face stress, pain and illness. New York: Dell Publishing.1990.59-114 M.J.Reea and M.A.Craigiea. Outcomes Following Mindfulness-Based Cognitive Therapy in a Heterogeneous Sample of Adult Outpatients.

Behav Cha. 2007; 24 (2) :70-86 R.A. Baer. Mindfulness training as a clinical intervention: A conceptual and empirical review.

Clin Psy Sci Prac. 2003;10: 125–43 I.W. Brown and R.M. Ryan. The benefits of being present: Mindfulness and its role in psychological well-being. J Personality and Social Psychology. 2003; 84(4), 822-48 S. Evans, S.Ferrando, M.Findler, C.Stowell, C.Smart and D.Haglin. Mindfulness-based cognitive therapy for generalized anxiety disorder.

J Pers Soc Psychol. 2008;22: 716-21

Address for correspondence: Seye Khadijeh Seyed Musavi, Department of Psychology,1 Islamic Azad University Branch of Ardebil-Basij - Ardebil-Iran E-Mail: dr_mari26@yahoo.com;

NLM ID : 8602438 (NlmId)

ISSN : 0970-7700 (Print)

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J. Res. Educ. Indian Med., April-June, 2014; Vol. XX (2): 95-101

ISSN 0970-7700

AN OBSERVATIONAL CLINICAL STUDY ON EFFECT OF USHTRASANA (YOGA) IN MANAGEMENT OF KATISHULA (LOW BACK PAIN) AND MANYASHULA (NECK PAIN) YADAV ARCHNA,1 SHUKLA RAKESH,2 PATWARDHAN RAVINDRA3â&#x20AC; AND ARORA MANISH4 College of Ayurved,1,3,4 Bharati Vidyapeeth Deemed University, Pune.- 411046, Maharashtra Department of Swasthavritta,2 SGNR College of Ayurved, Sriganganaga -335001 Rajasthan (India).

Abstract: Background: Stressful life style, lack of physical activities, exercise and prolonged wrong postures results in unequal and inappropriate muscle tension. Fear, anxiety and tension also lead to the muscles to unnecessary spasms. The above coupled with lack of exercise can cause muscle dysfunction. Ushtrasana (camel pose) releases stress and anxiety. It helps to heal many different spinal ailments. Aim: To study the effect of Ushtrasana in management of Katishula with Manyashula. Methodology: Clinical trial on 30 individuals between the age group of 30-50 years of either sex was carried out for 60 days. Results: 26.67% of individuals have shown Marked response, 36.67% shown Moderate response and 36.66% shown Mild response. Conclusion: Ushtrasana (Backward bending pose) reduces back pain by stretching and strengthening the muscles. It creates maximum compression of spines which stimulates the nervous system and also improves flexibility of neck and spine. Ushtrasana definitely plays an important role in management of Kati Shula (low back pain), Manyashula (neck pain) and associated symptoms without any side effects.

Keywords: Katishula, Manyashula, Neck and Low Back Pain, Ushtrasana, Yoga Treatment.

Introduction Yoga is the science of linking the individual self with the universal self; both the Yoga and Ayurvedic sciences aim at developing the physical, mental, intellectual, emotional and spiritual levels of human being.

Nasti Yogata Param Balam (Gheranda Samhita)[6] Yoga and Ayurveda have inseparable relationship, both illuminate the basic laws and principles governing life on earth. In the desire for more and more comfortable and easy life, man has changed his life style, from the prevedic period to modern era, continuously. Man has changed his habits of eating, sleeping and travelling. The sedentary life style and improper sitting postures create pain in neck, shoulder, back, lower back region and lifestyle disorders.

Luxurious stressful lifestyle and lack of exercise results in unequal and inappropriate muscle

tension and ligamental creep due to wrong postures. Fear, anxiety, tension also subject the muscles to unnecessary contraction and spasms.

The above coupled with lack of proper exercise causes muscle dysfunction.

Yoga has a great role to prevent and cure many of the life style disorders. The Yogic Asanas can be practiced without causing much undue disturbances in the daily routine by almost everybody.

Backward bending pose reduce back pain by stretching and strengthening the muscles.

Ushtrasana is one of the important Asana as described in ancient texts; it is also known as camel posture. It creates maximum compression of spines which stimulates the nervous system and also improves flexibility of neck and spine (Brian 2013).[4] Camel pose is posture that releases much stress and anxiety and helps to heal many different spinal ailments.

1. PG Scholar 2. Asst. Professor 3. Professor 4. Asst. Professor â&#x20AC; Author contributed equally to this work.

96

Yadav et al.

Hence, an attempt has been made to study the combined effect of Ushtrasana in Katishula (low back pain) with Manyashula (neck pain).

Aim and Objects To clinically evaluate the effect of Ushtrasana in management of Katishula with Manyashula (combined effect on both diseases).

Methods and Materials Type of Study: A single group clinical trial on 30 patients between the age group of 30-50 years of either sex was carried out. All 30 patients were asked to follow the Ushtrasana procedure under supervision and guidance of a trained yoga therapist.

Period of study: 60 days Yoga module adopted - Aasana: Ushtrasana.

- Time: 15 mins for each Session.

Morning: In between 6-7 a.m.

Operational Procedure(Iyengar 2005 pg 50)[2] Pre procedure Omkara chanting for 2 mins.

Stretching exercise for 3 mins Main procedure Knee on the floor, knees and thighs together and toenails resting on the floor. Extend the toes backward.

Rest palms on buttocks so that the fingers point towards the feet. The elbows should point backward and one should feel the sternum bone lifted to the front.

Stretch the thighs and curve the spine backward extending the ribs.

Exhale; Lower the left palm on the left heel and the right palm on the right heel. Try to rest the palms on the soles of feet, press feet with the palms. Keep ankles in touch with the floor.

Throw head back and push the spine towards thighs, which should be perpendicular to the floor.

Contract buttocks and stretch the spine further, keeping the neck stretched back.

Remain in this position, breathing normally.

Release your hands one by one and rest them on the buttocks. Then sit on the floor and relax.

Post procedure Relaxation â&#x20AC;&#x201C; 2 mins.

Time Duration of Ushtrasana It is suggested that one should retain this posture for the time duration on inhaling or if one choose to breathe while retaining Ushtrasana posture then one should retain it for 30-60 seconds (Iyengar 2005 pg 50).[2] Total time for Asana procedure prescribed was for 15 mins.

Important Instruction 1.

Ushtrasana should be practiced on an empty stomach either after 3 hours of a major meal or after 1 hour of liquids (Swami Sivanand 1998).[9] 2.

Asana should be done in a clean dry place devoid of insects and no noise either.

3.

Spread a folded blanket on the floor and practice on it.

4.

During Asana, breathe through the nose.

Always breathe normally unless otherwise directed.

5.

In the beginning, Ushtrasana may be practiced for a few seconds and gradually increase the duration of time.

6.

Yogasana is a non- violent activity and therefore should be performed with no jerks or rapid movements of the body.

7.

Regularity is the most important.

8.

Observing definite time schedule as per guidance and practicing at the same place will add to the advantage.

Procedure of data collection: Special clinical proforma regarding this topic was prepared and observations were noted.

Follow up Follow up was done periodically for total duration of 60 Days for follow up.

1st follow up - On 7th day 2nd follow up - On 15th day

Ushtrasana on Katishula and Manyashula

3rd follow up 4th follow up 5th follow up

0

- On 30th day - On 45th day - On 60th day (Post treatment)

1 2 3 4 5 6 7 8 9 Visual Analogue Score (VAS)

10

Table 1. Assessment Parameters Ruka (Pain Level):

VAS

Grade – 0

No Pain (0-1)

Grade – 1

Mild Pain (2-4)

Figure 7

Grade – 2

Moderate Pain (5-7)

Grade – 3

Severe Pain (8-10)

General Function Ability: Grade – 0

Complete ability to carry on all usual duties without handicap

Grade – 1

Adequate normal activity despite handicap of discomfort or limited joint movement

Grade – 2

Limited only to little or none of the usual occupation or self-care

Grade - 3

Bedridden or confined to wheel chair, little or no self-care

Stambha (Stiffness): Grade – 0

0 – 5 minutes

Grade – 1.

5 minutes to 2 hours

Grade – 2

2 hours to 8 hours

Grade – 3

More than 8 hours

Toda (Pricking Sensation): Grade – 0

No pricking sensation

Grade – 1

Mild pricking sensation

Grade – 2

Moderate pricking sensation

Grade – 3

Severe pricking sensations

Straight Leg Raise test (SLR test): Grade – 0

More than 90°

Grade – 1

61°-90°

Grade – 2

31°-60°

Grade – 3

0 °- 30°

SLR test was carried out in all patients

Assessment criteria Manyashula (neck pain) and Katishula (low back pain) assessed on visual analogue score (VAS) for grading pain (Ruka).

97

Statement of Limitations Inclusion Criteria 1. Individuals having complaint of Katishula with Manyashula together only were included.

2. Individuals between age group of 30 to 50 years were included.

3. Both male and female cases were included.

Exclusion Criteria 1. Patients of Manyashula and Katishula, who are contraindicated for Ushtrasana were excluded (Iyengar 2005 pg 39-40).[2] 2. Secondary cases of Katishula and Manyashula were excluded.

3. Individuals having T.B. of spine, Bamboo spine, Ankylosing spondylitis, malignancy and accidental cases were excluded.

4. Individuals suffering from any other systemic disease were also excluded.

Lab Investigations Routine laboratory investigations were carried out along with x-ray (lumbar and cervical spine) for diagnostic purpose.

Observation: Data Analysis Data analysis consisted of two parts, first part to describe the characteristic of the study subjects by using descriptive methods viz mean, median, S.D. and percentage. Second part consisted of comparisons of pre treatment measurements of the outcome with that of post treatment measurements where we used inferential methods and statistics. In the descriptive part, we used frequency tables and appropriate diagrams. In the inferential part, we used Paired t-test procedure at 5% level of significance and data interpreted using the value of the test statistic and the probability (p) value.

Age, Sex and Prakruti Age, Sex and Prakruti (body type)wise distribution of patients is depicted in Table 2, Table 3 and Table 4 respectively.

98

Yadav et al.

Prakruti wise distribution [Table 4] shows more patients 8 (26.67 %) were of Vata Pitta Pradhan. Out of 30 patients [Table 5], Only 7 (23.33%) patients had proper Vyayam, 8 (26.67%) patients didnâ&#x20AC;&#x2122;t do any type of Vyayam (exercise).

Out of 30 patients, Only 9 (30%) patients had proper sleep, 14 (46.67%) patients had disturbed sleep and 7 (23.33%) patients did Jagran (Night Awakening) due to job or pain [Table 6].

Results Table 7 contains the effect on Ruka (Pain), Stambha (Stiffness) and Toda (Prickling sensation). P Value is significant for Ruka, Stambha and Toda as it less than 0.05. In Ruka, Katishula and Manyashula has shown 52.01% Table 2. Distribution according to Age Age

No of patients

%

30-35

8

26.67

36-40

3

10

41-45

11

36.67

46-50

8

26.67

Table 3. Distribution according to Sex Sex

No of patients

%

Male

23

76.67

Female

7

23.33

Table 4. Prakruti wise distribution Prakruti

No of patients

%

VP

8

26.67

PK

5

16.67

VK

5

16.67

KP

3

10

KV

5

16.67

PV

4

13.33

Table 5. Distribution according to Vyayam (Exercise) Vyayam

No of patients

%

Proper

7

23.33

Less

15

50

No

8

26.67

Table 6. Distribution according to Nidra (Sleep) Nidra

No of patients

%

Sound

9

30

Disturbed

14

46.67

Jagran

7

23.33

and 57.70% relief respectively. For Stambha, Katishula 61.23%, Manyashula 64.01%. In Toda, Katishula has shown 62.51% relief and Manyashula 56.72% relief.

Effect on G.F.A., before treatment mean value was 1.567 which reduced to 0.6 and shown 61.69% improvement. P value is significant at 5% level of significance. Effect on SLR, before treatment mean value was 1.663 which was reduces to 0.70 and shown 57.12% relief and P value is significance, less than 0.05. Table 8 shows the details of effect on General Function Ability (GFA) and Straight Leg Raise test (SLR test) in studied patients.

Discussion Manyashula Manyashula (Neck pain) has been described as one among the Nanatmaja vyadhi cause by Vata Dosha (Charaka Samhita, Sutra Sthana, 20/11).[1] The Nidana (Etiology) causes the vitiation of Vata, which in turn lodges into the Mamsa-Asthi Dhatu (Muscles - bones). The movement of the joints is performed by the Shleshmaka Kapha (synovial fluid) situated in the joints. Later the aggravated Vata diminishes this Shleshmaka Kapha, which further facilitates the restricted movements (Madhav Nidana, Vata Vyadhi Nidana, 22/51).[7] Katishula (low back pain) Nidana (etiological factors) causes Vata Prakopa (aggravation) especially Apana Vata, as Pakwashaya (large intestine), Kati (lower back) and Sakthi (thigh) are the important sites of Vata.

Vata Prakopa (aggravation) is more prominent in these regions, leading to etiopathogenesis and symptoms.

Continuous Nidana Sevana increases Apana Dushti further vitiates other Vayus.

Ushtrasana on Katishula and Manyashula

99

Table 7. Effect on Ruka (pain), Stambha (stiffness) and Toda (prickling sensation) B.T. mean

A.T. mean

% Relief

S.D of difference

t - cal

t –table

p - value

Katishula

1.667

0.80

52.01

0.7303

6.5

2.0452

< 0.0001

Manyashula

1.733

0.733

57.70

0.6948

7.883

2.0452

< 0.0001

Effect on Ruka (pain)

Effect on Stambha (stiffness) Katishula

1.633

0.633

61.23

0.4549

12.04

2.0452

< 0.0001

Manya shula

1.667

0.60

64.01

0.4498

12.99

2.0452

< 0.0001

Effect on Toda (prickling sensation) Katishula

1.067

0.40

62.51

0.7112

5.135

2.0452

< 0.0001

Manyashula

1.233

0.533

56.72

0.9154

4.188

2.0452

< 0.0001

Table 8. Effect on General Function Ability (G.F.A.) and Straight Leg Raise test (S.L.R.test) Before Treatment (mean) G.F.A. 1.567 S.L.R. test 1.633

After Treatment (mean)

Percentage Relief

S.D of difference

t - cal

t –table

p - value

0.60

61.69

0.6687

7.918

2.0452

< 0.0001

0.70

57.12

0.5833

8.764

2.0452

< 0.0001

Discussion on Observation Age : In Spondylosis degenerative changes in the intervertebral joints can start after 40 years of age which become more common around 45 years of age. The present data signifies age factor in Spondylosis in accordance with textual references (O’Neill TW et al. 1999).[8] Sex : The study reveals that males were more susceptible to the disease. This could be due to their strenuous activities and inadequate rest pattern.

Prakruti : Maximum number of patients Prakruti had Vata Dosha involvement i.e. 72% (Vata-pitta and Vata-kapha) are more susceptible to disorders of Vata.

Vyayam (Exercise) : The study shows that persons with less exercise are more susceptible for Katishula and Manyashula.

Table 9. Showing Samprapti Ghataka of Manyashula

Table 10. Showing Samprapti Ghataka of Katishula

Nidra (Sleep) :The study shows improper sleep as a contributing factor for Katishula and Samprapti Ghataka of Katishula

Samprapti Ghataka of Manyashula Dosha

Vata (Vyana) Pradhana, Kapha (Shleshaka) Dosha

Dushya (Vitiated) Dhatu

Rakta, Mamsa, Meda, Asthi

Upadhatu

Snayu, Sira, Kandara

Agni

Jatharagni mandya causes Ama

Strotas (Channels)

Asthi, Raktha, Mamsa and Vata vaha Strotas.

Stroto Dushti

Sanga (Accumulation)

Udbhava Sthana

Amapakwashaya, Samuttha

Dosha

Vata, Kapha

Dushya

Dhatu-Asthi, Majja Upadhatu-Sira, Snayu

(Vitiated) Dhatu

Mala

Purisha (Faeces)

Strotas

Asthivaha

Prakara

Sangaand Vimarga Gamana

Udbhava Sthana

Pakwashaya

Sanchara Sthana

Shakha

Rogamarga

Madhyama

Sthana-samsraya

Kati Pradesha Kati-trika-prushta-vamsha Gata Pradesha

Sanchara Sthana

Rasayani

Vyaktha Sthana

Manya (Neck)

Vyakta Sthana

Adhishtan

Manya

Adhisthana

Asthi Sandhi

Rogamarga

Madhyama Roga Marga

Swabhava

Chirakari

100

Yadav et al.

Manyashula as it is Vata Prakopa Kara (Vata aggravating).

Discussion on Result Ruka (Pain) : Due to Sthiratwa (Stability) and Vata Shamana Guna (pacifying quality) of Asana, aggravated Vata subsides and pain reduces. The pain, stiffness and decrease in the range of movement at the spine are due to structural changes in the joint.

Stambha (Stiffness) : The gentle stretching of muscles and joints –releases muscle tension – increases flexibility thus helps in removal stiffness.

Toda (Prickling sensation) : Continuous doing of the Ushtrasana lead to automatic postural correction, relaxation of contracted muscles and normal flow of Vata in Kati pradesha (lower back region). Thus aggravated Vata guna like Chala (move), Ruksha (dry), Toda (prickling) and Laghu (light) are reduced.

General function ability test There was 61.69 % improvement in general functions (By holding the position and progressively relax). Superficial muscles are relaxed; nervous system start relaxing the final position is maintained more than 20 seconds, this stimulates clasp-knife reflex and golgi tendon reflex- responsible for relaxing muscles (Botte et al. 1988).[3] This relaxation allows flexing of muscles and one can stretch muscle without effort even more. Ushtrasana causes Vata shaman and increases Mamsa Dhatubala and Asthipushti (nourishment to bones).

S.L.R. test The stretching of the joints in Ushtrasana causes the secretion of the lubricant called the synovial fluid is released and keeps them supple this improves the range of S.L.R. test (Eric L Radin 1972).[5] Probable Mode of Action (Figure 1) — Due to Asana’s Sthirartwa Guna (stability) Ushtrasana causes Vata Shaman (pacify Vata) and increase Mamsa Dhatu Bala (strength).

— Vata Guna like Chala (move), Ruksha (dry), Toda (prickling) and Laghu (light) are reducing.

— It causes Asthipushti and Shula Prashaman.

— By holding the position and progressively relax, superficial muscles relax, nervous system start relaxing the final position is maintained more than 20 seconds, which stimulate clasp-knife reflex and golgi tendon reflex- responsible for relaxing muscles.

— This relaxation allows flexing of muscles and one can stretch muscles without more effort.

— The gentle stretching of muscles and joints – releases muscle tension –increases flexibility thus helps in removal of stiffness.

— Regular practices of the Ushtrasana lead to postural correction, relaxation of contracted muscles and normal flow of Vata in Kati pradesha. Thus aggravated Vata get subside.

— Collective effect of Sthiratwa, Vata Shaman and Asthi pushti causes reduction in Katishula (low back pain) and Manyashula (neck pain).

Figure 1. Probable mode of action of Ushtrasana

Ushtrasana on Katishula and Manyashula

Conclusion Backward bending Yogic posture (Ushtrasana) reduce back pain by stretching and strengthening the muscles.

Ushtrasana creates maximum compression of spines which stimulates the nervous system and also improves flexibility of neck and spine.

Ushtrasana can play an important role in management of Katishula, Manyashula and associated symptoms without any side effects.

Yogasana’s have been considered as the convenient, drug less and inexpensive method for Katishula and Manyashula management.

Limitations The clinical study is limited to Ushtrasana only. The study can be compared with other alternative therapies like Panchakarma and physiotherapy etc. with larger data.

Effect on Katishula and Manyashula is studied only; effect of Ushtrasana on other system can also be studied.

1.

References Agnivesha. Charaka Samhita, Maharoga Adhyaya, Sutra Sthana, 20/11, Edited by Dr.

2.

3.

4.

5.

6.

7.

8.

9.

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Brahmanand Tripathi. Varanasi, Chaukhamba Sanskrit Sansthan, 2009; 390.

B.K.S. Iyengar. The Illustrated Light on Yoga, 1st edition. Noida, India, Harper Collins Publishers India Pvt. Ltd., 2005;39-40, 50.

Botte, Michael JMD, Nickel, Vernon LMD, Akeson and Wayne HMD. Spasticity and Contracture Physiologic Aspects of Formation.

Clin Orthop Relat Res 1988;233(4):7-18 Brian L Tracy and Cady EF Hart. Bikram Yoga Training and Physical Fitness in Healthy Young Adults. Journal of Strength and Conditioning Research 2013; 27(3):822-83.

Eric L Radin and Igor L Paul. A Consolidated Concept of Joint Lubrication. Bone Joint Surg Am1972; 54(3):607-616 Gheranda Samhita. Srisa Raj Chandra Vasu, 1st edition. Varanasi, Chaukhambha Sanskrit Pratishthan, 2003; 4.

Madhavkar. Madhav Nidana, Vata Vyadhi Nidana 22/51, Edited Dr. Brahmanad Tripathi. Varanasi, Chaukhanba Surbharti Prakashan, 2007; 536.

O’Neill TW, McCloskey EV, Kanis JA, et al.

The distribution, determinants, and clinical correlates of vertebral osteophytosis: A population based survey. J Rheumatol 1999;26:842–8.

Sri swami Sivananda. Essence of yoga, 13th edition. Garhwal, India. The divine life society publication, 1998; 4.

Address for Correspondence: Dr Rakesh Shukla, A/21, Shashwat Appt, Camp Road, Shahibaug, Ahmedabad, Gujarat (India) drrakesh.ayur@gmail.com,

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ISSN 0970-7700

ROLE OF STRESS FACTOR IN THE PATHOGENESIS OF DIABETES MELLITUS AND ITS TREATMENT WITH MEDHYA RASAYANA - A CLINICAL STUDY BALDEV KUMAR,1 SHWETA DEWAN,2 HETAL.H.DAVE 3 AND PUSPENDRA4 Department of Basic Principles,1*,2 National Institute of Ayurveda, Jaipur, Rajasthan (India) Department of Prasuti Tantra,3 National Institute of Ayurveda, Jaipur, Rajasthan (India) Department of Basic Principles,4 B.P.S Mahila Vishvavidhayala, Khanpur Kalan,Haryana (India) Abstract : Background - Today stress has become the wild animal and an inescapable part of modern life. Diabetes mellitus is a giant disease, considered as one of the arch enemy of the mankind. India is having the 18% of total diabetic population of the world. In anxiety and stress prone individuals, the samprapti (pathogenesis) of Prameha(Diabetes Mellitus) starts from the vitiation of agni (digestive fire) leading to amotpatti (indigestive juice) and that ama when settles in basti (urinary bladder), it leads to manifestation of Prameha. Madhumehari churna has antidiabetic properties and MedhyaRasayana has the molecular nutrients for the brain and is claimed to relieve stress. Aims and Objectives - (1)To establish stress factor as nidana (causative factor) of Prameha. (2)To analyze the effect of MedhyaRasayana to treat the stress factor involved in the pathogenesis of Diabetes mellitus. Materials and Methods - A total number of 60 patients aged between 20-70 years suffering from salient feature of stress involved non-insulin dependent diabetes mellitus were registered. The patients were divided into 3 groups. Group A included patients with slight and moderately high blood sugar, and were treated with MedhyaRasayan churna 2gm BD. Group B included patients with high blood sugar, and were treated with Madhumehari churna 5gm BD. Group C included patients with high blood sugar, and were treated with both MedhyaRasayan 2 gm. + Madhumehari churna 5gm. B.D with Luke warm water before meal for a period of 4 months. Results - Group C had statistically significant relief on almost all symptoms of Prameha as compared to Group A and Group B. Conclusion - (1) There is a role of negative Manasika Bhavas (psychic traits) in the formation of Ama , thus acting as one the primary factor in the pathogenesis of Prameha. (2) Prameha can be managed by changing mode of life style and decreasing stress hormones by use of MedhyaRasayana.

Keywords: Diabetes mellitus, Samprapti, Agni, Amotpatti, Prameha, Madhumehari Churna, Medhya Rasayan, Negative Manasika Bhavas.

Introduction For materialistic gains and competition in each and every field, forces a person to behave like a machine. This disturbs the equilibrium of mind. Ultimately he falls under the category of stress which affects people of all ages and in all walks of life. People experiencing severe stress are often accompanied by tension, anger, fear and frustration. According to several major studies, stress induced dysfunctions lead to an annual $17 billion decreased productivity and $ 1. Associate

60 billion physical illness.1 This is becoming a worst growing problem. Today, man is subjected to a major event of stresses in modern fast way of life and the balance is frequently disturbed.

Among the several health problems Diabetes mellitus is a giant disease considered as one of the arch enemy of the mankind. According to the International Diabetes Federation (IDF), 3.8 million people worldwide die from diabetes and related illnesses annually. In only 20 years the number of people with diabetes has exploded

Professor. 2. MD Scholar 3. Lecturer 4. Reader

104

Baldev, Shweta, Hetal and Puspendra

from 30 million to 246 million. By 2025 there will be approximately 380 million people living with diabetes, with the highest increases in new cases occurring in the most diabetics in India at 40.9 million followed by China with 39.8 million.2 Around 3.2 million deaths every year are attributable to complications of diabetes i.e. six deaths every minute.3 Recent studies in China, Canada, USA and several European countries have shown that feasible lifestyle interventions can prevent the onset of diabetes in people at high risk.4 Diabetes mellitus can very well be taken care of by Ayurvedic drugs without any hazardous side effects. Madhumeha (diabetes mellitus) is among the 20 subtype of pramehas and is tridoshaj disease.5 It is believed that Diabetes mellitus occurs when insulin is not able to metabolize glucose (derailment of glucose metabolism)6. Here Ayurveda believes that it occurs mainly due to medodushti. This medodushti (fat) vitiate mamsa, rakta (blood), kleda and ojas (immunity power).7 All the dhatus, malas & doshas are involved in the disease procedure. Charaka says that the disease is also manifested due to ojodushti (when a person eats a rich diet with lack of exercise, it leads to vitiation of ojas, which in turn vitiates (avarita) the mutravaha srotas (urine excretory system) precipitating in the pathogenesis of prameha).8 It seems to be the description of autoimmune diabetes mellitus. In nidana (basic cause) and chikitsa sthanas the pathogenesis starts with vitiation of medas.9 According to Charaka the manasa doshas â&#x20AC;&#x201C; rajas and tamas have a very great adverse effect on the body as well as on all the three dosha.10 In Charaka (Prameha Nidana & Chikitsa) and Sushruta (Prameha Nidana)11, krodha (anger) is among one of the etiological factors in paittika prameha and shoka (grief), bhaya (fear), udvega (anxiety) and chinta (worry) for the vatika prameha (madhumeha is among vatika prameha) 12 , which leads to derailment of glucose metabolism. According to Sushruta disturbed state of psyche (manasa) is not able to digest the food even if taken in normal quantity and leads to formation of ama.13

In anxiety and stress prone individuals the samprapti starts from the vitiation of agni leading to amotpatti and that ama when settles in basti (Urinary bladder) leads to pathogenesis of prameha as mentioned in Grahaniroga.14The disease is classified as Sahaja and apathyanimittaja 15, Krisha (emaciated) and sthoola (obesity), Durbala (weak) and Balwana (powerfull).16On the basis of aetiology two main categories of diabetes are recognized, namely primary & secondary diabetes.17 Primary diabetes is classified into two groups â&#x20AC;&#x201C; IDDM (Type 1) and NIDDM (Type 2). IDDM is most frequent in those less than 50 years old & rapidly fatal without treatment with insulin. NIDDM (Type II) occurring mainly in the middle-aged & elderly and compatible with long survival without treatment. Secondary Diabetes â&#x20AC;&#x201C; Diabetes occurs as a result of a recognizable pathological process or secondary to the treatment of some other condition i.e. Pancreatic Diabetes, Insulin Antagonists, Iatrogenic Diabetes and Liver disease etc.

Therefore, a common psychosomatic problem diabetes mellitus has been selected for study. Care has been taken to select the formulation as per classical reference having its efficacy on diabetes mellitus. Madhumehari Churna has Deepana (appetiser), Pachana (digestive) and anti- diabetic properties and hence it was presumed that it must be effective in diabetes mellitus. MedhyaRasayana group of drugs described in ancient literature has got the molecular nutrients for the brain, and claimed to relieve mental fatigue, anxiety, and stress at psychological and neuro-endocrine level.

Aims and Objectives 1.To establish stress factor as nidana (causative factor) of Prameha.

2.To analyze the critical review of the stress factor involved in conceptual study of Diabetes mellitus.

3.To analyze the effect of MedhyaRasayana to treat the stress factor involved in the pathogenesis of Diabetes mellitus.

Stress in the pathogenesis of diabetes mellitus and its treatment with Medhya Rasayana

Material and Methods Selection of patients A total number of 60 patients aged between 20-70 years suffering from salient feature of stress involved non-insulin dependent diabetes mellitus were registered. The patients were divided into 3 groups. Group A included patients with slight and moderately high blood sugar, and were treated with MedhyaRasayana churna 2gm BD. Group B included patients with high blood sugar, and were treated with Madhumehari churna 5gm BD. Group C included patients Figure 7 with high blood sugar, and were treated with both MedhyaRasayana 2 gm. + Madhumehari churna 5gm. B.D with Luke warm water before meal for a period of 4 months.

Note- 1.

Patients with uncontrolled diabetes mellitus were allowed to take oral hypoglycemic drugs whatever they were taking in group-B & group-C.) 2.For this study the normal range of FBS was considered to be between 60-100 mg/ dl and PPBS between 100-140 mg/dl as per

Pathological Lab. of N.I.A. Hospital. All the patients having blood glucose level higher than these normal values were labeled as having diabetes mellitus and those who were having the symptoms of madhumeha were screened for blood sugar and Urine Sugar.

Selection of drug The drugs MedhyaRasayana Churna & Madhumehari Churna were prepared and both were given in a dose of 2 gm. & 5 gm. respectively twice a day with Luke warm water before meal for 4 months.

Sample size: 60 patients Drop outs: none Total pa-tients who completed the trial: 60 Grouping 60 patients under trial were subdivided into three groups i.e. Group A, Group B and Group C (each 20 patients) to compare the effects therapies.

Group A -slight and moderately high blood sugar, MedhyaRasayana Churna 2gm BD, with

Table 1. Table showing contents of Medhya Rasayana S. No

Name of drug

Latin name

Part used

Proportion

1

Brahmi

Centella asiatica

Panchanga

1 part

2

Shankhpushpi

Convolvulus pluricaulis

Panchanga (whole part)

1 part

3

Jatamansi

Nordostachys jatamansi

Moola(root)

1 part

4

Vacha

Acorus calamus

Kanda

Âź part

Table 2. Table showing contents of Madhumehari Churna S. No.

Name of drug

105

Part used

Proportion

1

Gudamara

Gymnema sylvestre

Latin name

Root

1 part

2

Jambu

Syzygium cumini

Seed

1 part

3

Karvellaka

Momordica charantia

Fruit

1 part

4

Nimba

Azadirachta indica

Seed

1 part

5

Babbula

Acacia arabica

Fruit

1 part

6

Methika

Trigonella foenum-graecum

Seed

1 part

7

Amrasthimajja

Mangifera indica

Seed

1 part

8

Trivrita

Operculina turpethum

Root

1 part

9

Vijayasara

Pterocarpus marsupium

Stem bark

1 part

106

Baldev, Shweta, Hetal and Puspendra

Luke warm water before meal for a period of 4 months.

Group B- high blood sugar, Madhumehari churna 5gm BD, with Luke warm water before meal for a period of 4 months.

Group Chigh blood sugar, MedhyaRasayana 2 gm. + Madhumehari churna 5gm. B.D with Luke warm water before meal for a period of 4 months.

Study setting Patients were selected from OPD & IPD of NIA hospital & Bombaywala Hospital, Jaipur, Rajasthan.

Diagnostic Criteria In an attempt to deal with these problems, the National Diabetes Data Group of the National Institutes of Health in 1979 revised the criteria for the diagnosis of diabetes: 1. Fasting (overnight): Venous plasma glucose concentration 7.8 m.mol/L (140 mg. / dl.) on at least two separate occasions.

2. Following ingestion of 75 g of glucose: Venous plasma glucose concentration 11.1 m.mol/ L (200 mg/dl.) at 2 hour and on at least one other occasion during the 2-h test; i.e., two values -11.1 m.mol/L (200 mg/dl.) must be obtained for diagnosis. If the 2-h value is between 7.8 and 11.1 m.mol/L (140 and 200 mg/dl.) and one other value during the 2-h test period is equal to or greater than 11.1 m.mol/L (200 mg/dl.), a diagnosis of “impaired glucose tolerance” is suggested. Persons in this category are at increased risk for the development of fasting hyperglycemias or symptomatic diabetes, but such progression is not predictable in an individual patient. In 1997 the American Diabetes Association recommended modified criteria for the diagnosis of diabetes mellitus, decreasing the diagnostic cut off for fasting plasma glucose to 7 m.mol/ L (126 mg/dl.). § But for this study the normal range of FBS was considered to be between 60-100 mg/ dl and PPBS between 100-140 mg/dl as per

Pathological Lab. of N.I.A. Hospital. All the patients having blood glucose level higher than these normal values were labeled as having diabetes mellitus and those who were having the symptoms of madhumeha were screened for blood sugar and Urine Sugar.

Inclusion Criteria · All the patient labelled as having diabetes mellitus i.e who presented with symptoms of Madhumeha were screened i.e. blood glucose, FBS was considered to be between 60-100 mg/ dl and PPBS between 100-140 mg/dl Exclusion Criteria: · Patients with complication of any cardiac problem. · Patients with complication of diabetes mellitus like diabetic nephropathies. · Patients of IDDM (Insulin dependant Diabetes Mellitus).

Investigations 1.

Blood: complete haemogram to rule out any other pathological condition.

2.

Biochemical examination: Blood sugar (fasting and post-prandial).

3.

Urine: Routine examination and microscopic examination.

All the investigations were carried out before and after the study.

Apart from Blood glucose criteria other investigations are carried out only for safety of the patients. These values were recorded both before and after treatment.

Assessment Criteria: Various physical symptoms of Madhumeha and Negative Emotions affecting the disease were assessed on the basis of criteria for assessment written in the Proforma. Psychological factors affecting the disease were assessed on the basis of BPRS. Lastly the effect of the drug was assessed on the basis of 1. Subjective criteria 2. Objective criteria

Stress in the pathogenesis of diabetes mellitus and its treatment with Medhya Rasayana

1. Subjective criteria: · Effect of the drug was assessed on the basis of relief percentage in each physical symptom of Madhumeha in total patients of all groups on the basis of proforma prepared for the purpose. · The role of Negative Emotion affecting the disease and effect of the drug was assessed on the basis of relief Percentage of each Negative Emotion present in total patients of each group. · The role of psychological factors affecting the disease and effect of the drug was assessed on the basis of relief Percentage on the basis of Ayurvedic description and Brief Psychiatric Rating Scale.

2. Objective criteria: · Fasting Blood Sugar, PPBS & Urine Sugar.

Pathya and Apathya( Do’s and don’ts) · All the patients were advised to follow controlled diet with restriction of sweet substances, reduction in milk product especially curd. As curd and milk are considered to be the nidana of prameha.

107

· All the patients were advised for exercise the most common is walking and also light yogic exercise. · The entire patients were advised for Dhyana Yoga (meditation) to pacify mind.

Statistical analysis: The information gathered on the basis of observations was subjected to statistical analysis in terms of mean score (x), standard deviation (SD) standard error (SE), paired t test was carried out at the level of 0.05, 0.01, 0.001 of P level. The obtained results were thus interpreted as18-20 P<0.05 – Improvement P<0.01 – Significant improvement P<0.001 – Highly significant Total Effect of therapy: Group-A (Slight and moderately high blood sugar, MedhyaRasayana Churna 2gm BD ) PrabhutaMutrata (Polyuria) 61.90%, Avila Mutrata 57.14%, Trishadhikya (polydypsia) 64.28%,Galatalushosha (dryness of mouth) 71.42%,Prabhuta Kshudha (polyphagia) 33.33%

Table 3. Effect of treatment in terms of relief percentage on physical symptoms of Madhumeha in all three Groups S. No.

Symptoms

Group A

Group B

Group C

1

Prabhuta Mutrata

2

Avila Mutrata

3

Trishadhikya

4

Galtalushosa

5

Prabhuta Kshudha (polyphagia)

33.33%

79.16%

60%

6

Cramps

9.09%

100%

90%

7

Shithilanga (Fatigue)

33.33%

70%

66.66%

8

Angagandha (Bad odour)

40%

00%

60%

9

Karpada Daha

42.85%

100%

55%

10

Karpad Suptata (tingling/ numbness)

83.33%

70%

72.41%

11

Weight loss

66.66%

56.25%

55.25%

12

Joint pain

62.5%

35.71%

61.29%

13

Libido

60%

44.44%

76.19%

14

Constipation

62.5%

60

75.86%

(Polyuria)

61.90%

61.90%

61.66%

57.14%

90%

70%

(polydypsia)

64.28%

73.68%

68.36%

(dryness of mouth)

71.42%

75%

57.69%

Baldev, Shweta, Hetal and Puspendra

108

Cramps 9.09% Shithilangata (Fatigue) 33.33%, Angagandha (Bad odour) 40%, Karpada Daha 42.85%, KarpadSuptata (Tingling/numbness in hand and leg) 83.33%, Weight loss 66.66%, Joint pain 62.5%, Libido 60%, Constipation 62.5%, Statistical values of S.D. = 4.48, S.E.=1.08, t=5.37, p=<0.001 i.e.

Highly Significant.

Group-B (high blood sugar, Madhumehari churna 5gm BD) was observed as-Prabhuta Mutrata (Polyuria) 61.90%, Avila Mutrata 90%, Trishadhikya (polydypsia) 73.68%, Galatalushosha (dryness of mouth) 75%, Prabhuta Kshudha (polyphagia) 79.16%, Cramps 100% Shithilangata (Fatigue) 70%, Angagandha (Bad odour) 00%, Karpada Daha 100%, KarpadSuptata (Tingling/numbness in hand and leg) 70%, Weight loss 56.25%, Joint pain 35.71%, Libido 44.44%, Constipation 60%, Statistical values of S.D. = 3.15, S.E.= 0.7, t= 4.85, p= <0.001 i.e. Highly Significant.

Group-C

(High blood sugar, MedhyaRasayana 2 gm. + Madhumehari churna 5gm. B.D )

was observed as- Prabhuta Mutrata (Polyuria) 61.66%, Avila Mutrata 70%, Trishadhikya (polydypsia) 68.36%, Galatalushosha (dryness of mouth) 57.69%,

PrabhutaKshudha (polyphagia) 60%, Cramps 90% Shithilangata (Fatigue) 66.66%, Angagandha (Bad odour) 60%, Karpada Daha 55%, KarpadSuptata (Tingling/numbness in hand and leg) 72.41%, Weight loss 55.25%, Joint pain 61.29%, Libido 76.19%, Constipation 75.86%, Statistical values of S.D. = 5.3, S.E.= 1.18, t= 9.78, p= <0.001 i.e. Highly Significant.

In Group A (slight and moderately high blood sugar (MedhyaRasayana Churna 2gm BD ) It was observed that the results were highly significant in case of FBS & PPBS while in case of Urine Sugar the effects of the drug were significant. The values of S.D., S.E., t & p for FBS were 9.12, 2.04, 8.5, <0.001, for PPBS were 13.75, 3.07, 7.0, <0.001 and for Urine Sugar were 0.5, 0.11, 3.6, <0.01 respectively.

In Group B (high blood sugar, Madhumehari churna 5gm BD) It was observed that the results were significant in case of FBS & Urine Sugar while in case of PPBS the effects of the drug were highly significant. The values for FBS are S.D. = 14.65, S.E. = 3.2, t= 3.2, p= <0.01for PPBS S.D. =30.75, S.E. =6.8, t=3.8 & p=<0.001.

Similarly for Urine Sugar are S.D.=0.75, S.E.=0.16, t=3.4 & p=<0.01.

Table 4. Effects of treatment on investigations of patients in all the Groups based on statistical significance Group

A

B

C

Variable

FBS

SD

9.12

SE

2.04

't'

8.5

p

<0.001

Results

HS

PPBS

13.75

3.07

7.0

<0.001

HS

Urine Sugar

0.5

0.11

3.6

<0.01

S

FBS

14.65

3.2

3.2

<0.01

S

PPBS

30.75

6.8

3.8

<0.001

HS

Urine Sugar

0.75

0.16

3.4

<0.01

S

FBS

57.67

12.90

3.7

<0.01

S

PPBS

60.28

3.48

5.6

<0.001

HS

Urine Sugar

0.5

0.13

4.6

<0.001

HS

Stress in the pathogenesis of diabetes mellitus and its treatment with Medhya Rasayana

I n G r o u p C ( h i g h b l o o d s u g a r, MedhyaRasayana 2 gm. + Madhumehari churna 5gm. B.D ) It was observed that the results were significant in case of FBS while in case of Urine Sugar & PPBS the effects of the drug were highly significant. The values for FBS were S.D. = 57.67, S.E. = 12.90, t= 3.7, p= <0.01for PPBS S.D. =60.28, S.E. =13.48, t=5.6 & p=<0.001.

Similarly for Urine Sugar were S.D.= 0.5, S.E.=0.13, t=4.6 & p=<0.001.

Insert Table 5: In Group A (slight and moderately high blood sugar, MedhyaRasayana Churna 2gm BD) : Krodha 62.08%, Raga 60%, Moha 61.76%, Upadhi63.63%, Shoka 65%, Bhaya 61.11% and Dvesha 64.7%. Statistical values of S.D. = 5.96, S.E.= 1.3, t= 3.73, p= <0.01 i.e. Significant.

In Group B (high blood sugar, Madhumehari churna 5gm BD) : Krodha 9.09%, Raga 16.66%, Moha 14.28%, Upadhi 00%, Shoka 13.04%, Bhaya 5.26% and Dvesha 4%. Statistical values of S.D. = 1.2, S.E.= 0.26, t= 2.88, p= <0.01 i.e. Significant.

In Group C (high blood sugar, MedhyaRasayana 2 gm. + Madhumehari churna 5gm. B.D ) : Krodha 53.25%, Raga 65.62%, Moha 75.75%, Upadhi 76.92%, Shoka 62.5%, Bhaya 56.52% and Dvesha 60%. Statistical values of S.D. = 7.5, S.E.= 1.67, t= 3.8, p= <0.01 i.e. Significant.

Table 5. Effect of treatment in terms of relief percentage on symptoms of Negative Manasbhavas.

Symptoms

G-A (in %)

G-B (in %)

G-C (in %)

109

Insert Table 6: In Group A (slight and moderately high bloodsugar, MedhyaRasayana Churna 2gm BD ) Somatic Concern 35.71 %, Anxiety 53.57%, Emotional Withdrawal 30.76% & Conceptual Disorganization 36.36%, Guilt Feelings 45.45%, Tension 26.47%, Mannerisms & Posturing 48.38%, Suspiciousness 46.42%, Grandiosity 30.30%, Hostility 40% & Hallucinatory Behaviour 53.57%, Motor Retardation 45.45%, Uncooperativeness 51.85%, Unusual thought content 39.13%, Blunted Affect 50%, Excitement 30.76% Statistical values of S.D. = 3.08, S.E.= .68, t = 13.08, p= <0.001 i.e. Significant.

In Group B (high blood sugar, Madhumehari churna 5gm BD) : Somatic Concern 31.42%, Anxiety -9.09%, Emotional Withdrawal 12% & Conceptual Disorganization 62.5%, Guilt Feelings 12%, Tension 00%, Table 6. Effect of treatment in terms of relief percentage on Brief Psychiatric Rating Scale( BPRS).

Symptoms

Somatic Concern

G-A (in %)

G-B (in %)

G-C (in %)

35.71

31.42

67.5

Anxiety

53.57

9.09

73.58

Emotional Withdrawal

30.76

12

76.74

Conceptual Disorganization

36.36

62.5

74.45

Guilt Feelings

45.45

12

63.15

Tension

26.47

00

52.63

Mannerisms & Posturing

48.38

29.62

58.33

Hostility

40

29.16

75.75

65.62

Hallucinatory Behaviour

53.57

16.12

78.57

Raga

60

16.66

Moha

61.76

14.28

75.75

Motor Retardation

44.45

16

62.96

Krodha

62.08

9.09

53.52

Uncooperativeness

51.85

7.14

82.60

Shoka

65

13.04

62.5

18.18

58.62

61.11

5.26

56.52

Unusual thought content

39.13

Bhaya Dvesha

64.74

4

60

Blunted Affect

50

9.52

70

Upadhi

63.63

00

76.92

Excitement

30.76

13.62

75

Baldev, Shweta, Hetal and Puspendra

110

Mannerisms & Posturing 29.62%, Suspiciousness 33.33%, Grandiosity 26.19%, Hostility 29.16% & Hallucinatory Behaviour 16.12%, Motor Retardation -16%, Uncooperativeness 7.14%, Unusual thought content 18.18%, Blunted Affect -9.52%, Excitement 13.62% Statistical values of S.D. = 4.18, S.E.= 0.935, t= 3.26, p= <0.01 i.e.

Significant.

I n G r o u p C (high blood sugar, Medhya Rasayana 2 gm.+Madhumehari churna 5gm. B.D) Somatic Concern 67.5%, Anxiety 73.58%, Emotional Withdrawal 76.74% & Conceptual Disorganization 74.45%, Guilt Feelings 63.15%, Tension 52.63%, Mannerisms & Posturing 58.33%, Suspiciousness 71.11%, Grandiosity 72%, Hostility 75.75% & Hallucinatory Behaviour 78.57%, Motor Retardation 62.96%, Uncooperativeness 82.60%, Unusual thought content 58.62%, Blunted Affect 70%, Excitement 75% Statistical values of S.D. = 8.18, S.E.= 1.82, t = 10.02, p= <0.001 i.e. Highly Significant.

Overall Total effect of Therapy Insert Table 7 It was observed that none of the patients got complete remission, only 5% patients were markedly improved, 43.3% were moderately improved, 41.6% were improved and 10% of the patients remained unchanged (Table-7).

Table 7. Overall effect of therapy in all the three Groups Effect of Therapy

G-A

G-B

G-C

Total

Complete Remission

Nil

Nil

Nil

Nil

Markedly Improved

02

Nil

01

5%

Moderately Improved

13

Nil

13

43%

Improved

05

14

06

41%

Unchanged

00

06

Nil

10%

Discussion The drug Medhya-rasayana Churna has good reputation for promoting mental health. In ancient literature, Medhya-Rasayana has been claimed to relieve mental fatigue, anxiety, stress

etc. as well as the promoter of the functions of “Buddhi” (wisdom) and “Manasa” by correcting the disturbances of “Rajas” and “Tamas”.

Madhumehari Churna having the properties of pachana, pramehaghna and medohara, thereby increases the Agni and has been significant in treatment of the disease.

Medhya-Rasayana Churna: The drug helped by correcting the impaired manovyapaar, being Medhya, Medodustihara & Deepana helped in correcting all the entities of the disease. It was observed that patients showed improvement in Manasa Bhavas and higher mental functions.

Diabetes mellitus is somatic disorder resulting from the psychosomatic conflict of human beings on account of various internal as well as external stressors. So the management protocol must be oriented to the psychic as well as somatic level. Here Medhya Rasayana has been adopted in order to affect both physical as well as psychological symptoms. All the four drugs (Centella Asiatica, Convolvulus pluricaulis, Nordostachys Jatamansi and Acorus Calamus) have Tikta rasa and Madhura-Katu Vipaka. Both madhura vipaka and Tikta rasa are considered as Medhya in Pharmacological action according to classics. Though Vipaka of Vacha and Jatamansi is katu but these drugs are included in Medhya Rasayana group. Moreover these drugs have properties like- Tridoshahara property– maintaining equilibrium of all the three doshas, Rasayana Property– Improve general health and immunity, Medhakara-Manasrogahara– Mental relaxation by potentiating of neural inhibition in CNS which is mediated by neurotransmitters.

Hence better management of the disturbed Manasika Bhavas in different therapeutic groups by giving mental health promoting drug (medhya) having effect on neuro endocrine system has additive effect in controlling the deranged blood sugar level.

Probable mode of action of Madhumehari Churna Having Kashaya Pradhana Tikta Rasa, Ushna Veerya (potency) and Laghu (light) Ruksha

Stress in the pathogenesis of diabetes mellitus and its treatment with Medhya Rasayana

(rough)Guna, this formulation helped in eliminating vitiated kapha & Medas. Both Medas and Kapha being the main entity of the Samprapti, thus by breaking the pathogenesis treated the disease. In treated group improvement in symptoms of deranged Medas was observed which suggests that the drug by correcting the deranged Medas, decreased the blood sugar. The results were significant on statistical ground and the trend suggests that drug was acting on Medas.

As the drug is Ushna it also increased Agni which draws attention that the drug is also improving Dhatvagni, (as Ayurveda belives that the disease is Amajanya). Thus it can be inferred that the drug acts by correcting the Medas and by increasing Agni (Dhatvagni). In combined group the results were observed still on higher side due to the combined effect of both the drugs.

Conclusion In many of the organic and metabolic disorders the role of Negative emotions has been elaborately explained in Ayurveda. But how they are developing into full-fledged pathology having a somatic route is seldom explained in this context.

Formation of Ama by Negative emotions produces chronic metabolic disorders. Altered external living sources like demographic alteration, change in family system, economy community structure, increased pace of migration, urbanization, industrialization, westernization have a potent role to induce the pathogenesis at Manasika level as well as body level. Repeated attachment with Udvega-Shokadi Bhavas / stress is the potent cause for morbidity and mortality rate by Madhumeha. These factors are not only responsible for the cause but for the complication also. By changing mode of life style, optimistic attitude, keeping faith in good, decreasing the stress hormones, high blood glucose level can be reduced. The effect of Medhya Rasayana and Madhumehari Churna was significant in treating Madhumeha.

1 2.

3.

4.

5.

6.

7.

8.

9.

10.

11.

12.

13.

111

References: http://care.diabetesjournals.org/cgi/reprint/32/1/193.

(Accessed 2009 Apr 27) IDF-Diabetes Atlas, 3rd edition, International Diabetes Federation, Brussels, 2007. http://www.emedicinehealth.com [Complications of Diabetes Mellitus] New York 2009 (Accessed 2009 Sept 21) w w w. w h o . i n t / n u t r i t i o n / p u b l i c a t i o n s / public_health_nut4.pdf(Diet, nutrition and the prevention of type 2 diabetes) NP Steyn [Accessed 2008 july 29]- ýAvailable from http:// w w w. w h o . i n t / n u t r i t i o n / p u b l i c a t i o n s / public_health_nut4.pdf Charaka Samhita. Chikitsa Sthana, Chapter 6 verse 8. Ed. Jadavji Trikamji Acharya, 5th edition.

Varanasi, Chowkhambha Surbharti Prakakashan, Reprint 2011; pg 445 Hall and Guyton. Textbook of Medical Physiology, Ed. John E. Hall, 8th ed. New Delhi, JP Brothers medical publishers limited, 1991 p 326-328.

Charaka Samhita. Chikitsa Sthana, Chapter 6 verse 8. Ed. Jadavji Trikamji Acharya, 5th edition.

Varanasi, Chowkhambha Surbharti Prakakashan, Reprint 2011; pp 445 Charaka Samhit. Sutra Sthana, Chapter 17 verse 80. Ed. Jadavji Trikamji Acharya, 5th edition.

Varanasi, Chowkhambha Surbharti Prakakashan, Reprint 2011; pp 103 Charaka Samhita. Chikitsa Sthana, Chapter 6 verse 5-6. Ed. Jadavji Trikamji Acharya, 5th edition. Varanasi, Chowkhambha Surbharti Prakakashan, Reprint 2011; pp 445.

Charaka Samhita. Sharira Sthana, Chapter 1 verse 102. Ed. Jadavji Trikamji Acharya, 5th edition. Varanasi, Chowkhambha Surbharti Prakakashan, Reprint 2011; pp 297.

Charaka Samhita. Nidana Sthana, Chapter 4 verse 24. Ed. Jadavji Trikamji Acharya, 5th edition.

Varanasi, Chowkhambha Surbharti Prakakashan, Reprint 2011; pp 214.

Charaka Samhita. Nidana Sthana, Chapter 4 verse 36. Ed. Jadavji Trikamji Acharya, 5th edition.

Varanasi, Chowkhambha Surbharti Prakakashan, Reprint 2011; pp 215.

Sushruta Samhita. Sutra Sthana, Chapter 46 verse 500-501. Ed. Jadavji Trikamji Acharya, 8th edition. Varanasi, Chowkhambha Surbharti Prakakashan, Reprint 2010; pp 251.

112 14.

15.

16.

17.

Baldev, Shweta, Hetal and Puspendra Charaka Samhita. Chikitsa Sthana, Chapter 15 verse 44-48. Ed. Jadavji Trikamji Acharya, 5th edition. Varanasi, Chowkhambha Surbharti Prakakashan, Reprint 2011; pp 517.

Sushruta Samhita. Chikitsa Sthana, chapter 11, verse 3. Ed. Jadavji Trikamji Acharya, 8th edition.

Varanasi, Chowkhambha Surbharti Prakakashan, Reprint 2010; pp 448.

Charaka Samhita. Chikitsa Sthana, Chapter 6 verse 15, Ed. Jadavji Trikamji Acharya,5th edition.

Varanasi, Chowkhambha Surbharti Prakakashan, Reprint 2011; pp 517.

Expert Committee on the Diagnosis and Classification of Diabetes Mellitus. Report of

18.

19.

20.

the Expert Committee on the Diagnosis and Classification of Diabetes Mellitus. Diabetes Care 1997; 20:1183â&#x20AC;&#x201C; 1197 Mahajan BK. Methods in Biostatistics for medical students and research workers. 6th ed. New Delhi: J P Brothers medical publishers limited, 2006; p 147150.

Mahajan BK. Methods in Biostatistics for medical students and research workers. 6th ed. New Delhi: J P Brothers medical publishers limited, 2006; p 168-85.

Mahajan BK. Methods in Biostatistics for medical students and research workers. 6th ed. New Delhi: J P Brothers medical publishers limited, 2006; p 142-147.

.

Address for correspondence: Dr.

Shweta Dewan, MD Scholar, Department of Basic Principles, National Institute of Ayurveda, Jaipur, Rajasthan (India) email: arorau51@yahoo.com

J Res Educ Indian Med, April-June 2014; XX (2):113-119

ISSN 0970-7700

CLINICAL EVALUATION OF KESHARAJA TAILA IN THE MANAGEMENT OF KHALITYA PRAMOD YADAV,1, PRIYANKA VERMA,2 NEELESH KHANDELWAL3 AND PRADEEP KUMAR PRAJAPATI4 Department of Rasashastra,1 MSM Institute of Ayurveda, BPSMV, Khanpur Kalan, Sonepat , Haryana (India).

Department of Rasa Shastra and Baishjaya Kalpna, IPGT & R A, Gujarat Ayurved University, Jamnagar â&#x20AC;&#x201C; 361008, Gujarat (India).

Abstract: Introduction: Hair loss is a common and distressing symptom. There is neither any specific treatment available for diffuse hair loss, or full understanding of the patho-physiology of this common disorder but dandruff is said to be the common cause of it. Massage greatly improves the blood circulation, thus increasing the health of the hair and also scalp. The aim of present study was to evaluate etiological factors responsible for hair fall and the assessment of efficacy of Kesharaja Taila in patients with diffuse hair loss. Material and Methods: 31 patients with diffuse hair loss were instructed to gently massage the Kesharaja Taila daily on to the entire area of the scalp. Response to the therapy was evaluated at the end of four weeks. Evaluation of efficacy was done on basis of improvement in clinical symptoms like hair fall, dandruff, itching, dryness etc.

Observations and Results: The present study showed significant reduction in hair fall, dandruff, itching etc. (p < 0.001). There were no adverse reactions, either reported or observed during the entire study period and overall compliance to the treatment was excellent. Conclusion: Kesharaja Taila was found to be effective in alleviating Khalitya along with significant effect on associated complaints.

Keywords: Dandruff; Kesharaja Taila; Khalitya; Massage

Introduction Hair fall is a universal problem, having affected both sexes of all races to different extents for as long as mankind has existed. For thousands of years, men and women of all countries and races have shared the tragedy of pre-mature hair loss.

Hair is one of the vital parts of the body derived from ectoderm of skin, is protective appendages on the body and considered accessory structure of the integument along with sebaceous glands, sweat glands and nails (Rathi V. et al.). [25] Throughout history and in most of civilizations, scalp hair has been associated with positive signals such as beauty and power.

Baldness or hair loss on the other hand has a negative attribution (Rushton DH. et al.) [26] Various factors contribute to hair fall / loss.

1. Assistant Professor,

Genetic predisposition and hormonal factors predominantly contribute to the above. Apart from hormonal factors, other reasons for hair loss in both the sexes can be stress, improper nutrition (A common reason for hair loss in women of all ages is improper nutrition), especially a lack of iron and protein, which are essential for maintaining healthy hair growth. Underlying medical conditions like diabetes or lupus, diseases such as typhoid, malaria, jaundice etc, also cause hair fall. The use of chemotherapeutic agents also cause hair fall (Ranganathan S and Shobana S.).[24] Management of hair fall is extremely complex. Although no sweeping cure exists for hair loss, a number of treatments are available to depending on their unique reasons for experiencing hair loss. Hormone therapy use of ĂĄreductase inhibitors, vasodilators like minoxidil are

2. M.D. (Ayu.) Scholar 3. M.D. (Ayu.) Scholar 4. Professor & Head of Department

114

Verma Priyanka et al.

Table 1. Ingredients of Kesharaja Taila.

Ingredient

Latin name / English name

Form used

Ratio

Bhringaraja

Eclipta alba Linn. Hassk.

Powdered Emblica officinalis, Terminalia chebula and Terminalia belerica.

Datura metel Linn.

Indigofera tinctoria Linn.

Ficus bengalensis Linn.

Pongamia pinnata Linn. Merr.

Croton tiglium Linn.

Abrus precatorious Linn.

Plumbago zeylanica Linn.

Calotropis procera Vitex negundo Linn.

Aconitum falconerii Stapf.

Hibiscus rosasinesis Linn.

Iron Green vitriol Oil of Sesamum indicum Linn.

Expressed juice (whole plant)

4 Parts

Decoction of coarse powder

4 Parts

Expressed juice of leaves Expressed juice of whole plant Decoction of aerial roots Paste of leaves Paste of purified seeds Paste of purified seeds Paste of fresh whole plant Paste of fresh leaves Paste of fresh leaves Coarse powder of tubers Paste of flowers Bhasma Shuddha and powdered Oil of black sesame seeds

4 Parts 4 Parts 4 Parts 1/40 Part 1/40 Part 1/40 Part 1/40 Part 1/40 Part 1/40 Part 1/40 Part 1/40 Part 1/40 Part 1/40 Part 4 Part QS

Triphala (Powder) Dhattura Neelini Vata Jata Karanja Jayapala Gunja Chitraka Arka Nirgundi Vatsanabha Japakusum Lauha Kasisa Krishna Tila Taila Water

widely used to reduce the hair fall / loss (Alastair JJ. et al.).[2] The use of some of the herbal oils is also reported to reduce the hair fall / loss (Krishnamoorthy JR. et al.).[21] The herbs used in the hair care have a definite history in the system of Ayruveda. About 1000 kinds of plant extract have been examined with respect to hair growth (Kapoor VP). [19] The present project work was designed to evaluate the efficacy of Kesharaja Taila in the management of hair fall due to various reasons.

The formulation does not have any classical reference. However depending upon the reported properties of its ingredients with reference to hair fall, they were incorporated in the study.

Therefore the study was planned with an aim to assess the efficacy of Kesharaja Taila in diffuse hair loss.

1. Materials and Methods 1.1 Manufacturing process Kesharaja Taila was prepared in the Dept. of Rasa Shastra and Bhaishajya Kalpana Including Drug Research by using ingredients as shown in Table 1 and following classical guidelines (Sharangdhara Samhita).[28]

1.2 Study design This study was an open, non-comparative, non-randomized, conducted at OPD level of the Department of Rasa Shastra and Bhaishajya Kalpana. A clinical proforma incorporating all the sign and symptoms (hair fall, dandruff, itching, hair dryness, stiffness, sweating and burning) was prepared and informed consent was taken from all the patients. 31 patients of both sexes, from the age group of 15-60 years, who were suffering from hair fall, dandruff, itching, hair dryness, stiffness, sweating, burning and who were willing to give informed consent were enrolled for the study. Ethical clearance was also obtained from institution for conducting the trial (No. PGT/7-A/Ethics 2011-2012/2796 Dated 13/ 12/2011). Trial was also registered retrospectively in Clinical Trials Registry â&#x20AC;&#x201C; India (Registration No. - CTRI/2012/10/003042 and Registered on: 05/10/2012).

Patients with severe hair fall due to endocrine disorders, patients with scanty hair and those patients with severe scalp skin infection were excluded from the study. Subjects with

Effect of Kesharaja Taila on hairfall

recent malaria, typhoid, jaundice and scalp diseases were excluded from the study. Similarly, lactating mothers, pregnant women, those who are on hormone or chemotherapy were also excluded from the study.

1.3 Medication Intervention Kesharaja Taila was provided to each of the patients and instructed to apply every alternate day on the scalp [6 ml / application]. Instructions were also given to massage the scalp gently for 10 min after application of hair oil. The patients were advised to use the oil 7in the morning. On Figure the day of hair wash, they were advised to apply the oil after bath. Total quantity of the oil was left to the usage practice of each patient. Total duration of study was 28 days. Each patient was reviewed in the OPD once in week over study period of 28 days. All patients were followed for a period of 2 weeks in order to check the compliance to the treatment.

Clinical assessment of scalp lesions was done objectively (by doctor) and also subjectively (by patient). Thorough scalp examination was done after completion of 1 week and at the end of the study. The severity of the dandruff symptoms, itching, white scales and hair fall were recorded.

1.4 Assessment of Chief Complaints Subjective assessment for the improvement in severity of symptoms viz. dandruff, itching, dryness, stiffness of hair, perspiration and burning sensation in scalp was scored as, Absent – 0, Mild – 1, Moderate - 2 and Severe – 3. For presence of hair fall, the assessment criteria was, No Hair Fall – 0, Hair fall during combing the wet hair or after oiling the hair & combing – 1, Hair fall during washing the hair and normal combing – 2 and Hair fall without combing – 3.

Srotodushti was assessed as per the signs and symptoms mentioned by Acharya Charaka (Charaka Samhita) [9] and incorporated in the clinical proforma.

The predefined primary efficacy endpoints were rapid clinical improvement and symptomatic control of the clinical condition. The predefined

115

secondary safety endpoints for short- and longterm were assessed by incidence of adverse events and patient compliance to the therapy.

1.5 Statistical Analysis Statistical analysis was done according to intention-to-treat principles. The changes in various parameters from baseline values and the values after 4 weeks were evaluated by “Paired ‘t’ Test”. The minimum level of significance was fixed at 99% confidence limit and a 2-sided p value of <0.001 was considered significant.

2. Results and Discussion Khalitya can be correlated to hair fall due presence of similar sign and symptoms. Total 31 patients were enrolled for the present work and all of them completed the course of treatment.

This signifies the urge associated with this clinical condition and a commons man’s urge to get rid of the disgrace of hair fall leading to baldness.

Maximum encountered patients in the clinical trials were females (Fig.-1). The popular belief is that men are more susceptible to hair fall, as baldness in men is triggered off by the male hormone androgen, which is responsible for destruction of the hair follicles. On the other hand, women who have both androgen and estrogen in their bodies are protected by the hormone estrogen, which counteracts and fights the negative effects of androgen. However in the present trial, more number of females was seen.

This may be due to short sample size. But the gravity of problem in both the sexes cannot be denied.

More number of patients enrolled for the present trial were between the age group of 15 – 30 yrs (64.52 %). Malnutrition, faulty dietary habits and stress are the main problems faced by this particular age group. These factors directly contribute to the Rasavaha Sroto Dushti leading to hair fall. Further, Lavana and Katu Rasa dominated the dietary habits of maximum patients (Fig.-1). Premature greying of hair and hair fall are attributed to excess consumption of Lavana Rasa (Charaka Samhita).[10] Lavana

116

Verma Priyanka et al.

Table 2. Effect of Kesharaja Taila on chief and associated complaints.

Sr. No 1

Hair fall

2

Dandruff

3

Itching

4

Kesha Rukshatva (dryness)

5

Kesha Kathinya (hardness)

6 7

Mean ± SEM

% change

‘t’ value

2.19 ± 0.13

87.17

17.37*

1.65 ± 0.17

83.60

09.64*

1.58 ± 0.18

98.00

08.58*

1.77 ± 0.15

88.71

12.28*

1.71 ± 0.16

88.33

10.56*

Keshabhomi Sweda (sweating)

1.07 ± 0.15

78.57

07.28*

Keshabhomi Daha (burning)

0.87 ± 0.15

84.37

06.02*

Symptom

* P < 0.0801 (highly significant)

predominant diet is a peculiarity of Saurashtra region (Jamnagar is a district located in Saurashtra region of Gujarat). Acharya Charaka has mentioned that people of Saurashtra are habituated for excessive consumption of salty diet and suffer from Khalitya, Palitya, Vali etc. (Charaka Samhita).[11] As far as vitiation of Srotas is concerned, Rasavaha Dushti was predominant followed by Asthivaha and Swedovaha (Fig.-2). It is easily reflected from the pattern of lifestyle followed in the particular area (Saurashtra). Palitya is one of the symptoms of Rasa Pradoshaja Vyadhi (Charaka Samhita).[12] Hair is said to be the Upadhatu (Sharangadhara Samhita) [27] as well as Mala (Charaka Samhita) [13] of Asthi Dhatu. Hair fall is mentioned as one of the symptoms of Asthi Kshaya (Charaka Samhita).

[14] Therefore, these findings support the involvement of particular Srotas in the etiology of hair fall.

Hair fall was found in all patients followed by dryness and stiffness (Fig.-3). Dandruff and itching were also found in 83.87 % patients (Fig.3). Epidemiological data shows that dandruff is the leading cause of itching and hair fall (Diana DZ. et al.). [17] Dandruff mostly occurs after puberty (between ages of 20 and 30 years) and affects males more than females (Shimer A. et al.) [30] In the present study maximum patients were from the particular age group and were males. Dandruff or Pityriasis simplex/ovale is often associated with other types of fungal infections (Gemmer CM. et al.). [18]

Associated complaints like local fungal infection (near neck, behind ears etc.), migraine, depression, diabetes and allergic conjunctivitis were also found in few patients. Migraine and depression indicate towards “Chintyanaam Atichintanaata”. This is the mental etiological factor responsible for Rasavaha Sroto Dushti (Charaka Samhita). [15] As far as effect of hair oil is concerned on chief complaints, maximum relief was found in itching followed by dryness, stiffness and hair fall (Fig.-4). On applying students ‘t’ test for the results obtained, highly significant result on all cardinal symptoms was seen. (Table 2).

Understanding the mode of action of Kesharaja Taila is a complex phenomenon. It may be due to the synergistic action of its constituent ingredients. Therefore they are analyzed individually for the reason of their inclusion in this particular formulation.

Bhringaraja has antibacterial (Karthikumar S. et al.) [20] and hair stabilizing properties (Thorat R. et al.) [31] In the present study, decoction of dried fruits of Terminalia bellerica, Terminalia chebula and Emblica officinalis were used. In one of the past studies, they were selected to check their antifungal activity by using different concentrations of extracts in various solvents.

Among them, Terminalia bellerica and Terminalia chebula exhibited good antifungal action against the test organism. Emblica officinalis did not show significant antidandruff activity. From the study, it was found that Terminalia bellerica and

Effect of Kesharaja Taila on hairfall

Fig. 1: General observations of 31 patients

Fig. 2: Sroto Dushti in 31 patients

Fig. 3: Chief complaints of 31 patients

Fig. 4: Effect of Kesharaja Taila on chief complaints

117

Terminalia chebula act as the good sources of antidandruff agents. Terminalia bellerica showed dose-dependent antidandruff activity. The aqueous extract of Terminalia bellerica exhibited a strong inhibition of 28 mm at 25 % concentration whereas the ethanolic extract showed 25mm inhibition zone in the same concentration (Balakrishnan KP. et al.). [5] Tannins present in Triphala possess the property of binding to proteins and even precipitating them.

They even react with bacterial cell walls; counteract fungi by interfering with surface proteins. Due to slightly astringent taste, their use tightens the surface of scalp and hair follicles, strengthening the folliclesâ&#x20AC;&#x2122; grasp on each hair (Bele AA. et al.). [6] Plant leaf extracts of Datura stramonium and Calotropis procera were found to be highly significant in reducing the radial growth of the pathogen (Sharma N and Trivedi PC). [29] Similarly, on phytochemical screening, antibacterial properties of leaves of Pongamia pinnata Linn. (Fabaceae) from India has been demonstrated (Arote SR. et al.). [4] Antibacterial and antifungal activity of methanolic extract of Abrus pulchellus Wall. and Abrus precatorius Linn. have also been proven (Prashith TR. et al.). [23] Petroleum ether extract of leaves and flowers of Hibiscus rosa-sinensis was evaluated for its potential on hair growth by in vivo and in vitro methods. In vivo, 1% extract of leaves and flowers in liquid paraffin was applied topically over the shaved skin of albino rats and monitored and assessed for 30 days. In vitro, the hair follicles from albino rat neonates were isolated and cultured in DMEM supplemented with 0.01 mg/ml petroleum ether extract of leaves and flowers. From the study it was concluded that the leaf extract, when compared to flower extract, exhibits more potency on hair growth (Adhirajan N. et al.). [1] Moreover, in vitro studies have demonstrated fungicidal activity of Hibiscus rosasinensis and the minimum inhibitory concentration for P. ovale between 500 and 1000 ĂŹg/ml (Krishnamoorthy JR and Ranganathan S).

[22] Hibiscus rosa-sinensis has potency for hair

118

Verma Priyanka et al.

follicle activation and hair growth, based on in vivo and in vitro methods (Adhirajan N. et al.).

[1] Lauha has been indicated as an ingredient for majority of hair oil preparations like Triphaladya Taila, Swalpa Bhringaraja Taila etc (Bhaishajya Ratnavali). [7] Kasisa has also been indicated for treating Indralupta (Bhaishajya Ratnavali). [8] Researches also show the role of iron and its compounds in maintenance of healthy hair (Aldridge RD). [3] On the basis of all the above research works, ingredients mentioned in Table 1 were incorporated in Kesharaja Taila for the present study.

None of the patients reported edema, erythema, pruritus or burning sensation on first as well as on continued application of the solution.

No adverse effects were either reported or observed during the entire study period and the overall compliance to the treatment was good.

However, the study is limited in various aspects. One of the aspects is small sample size.

It does not give a vivid picture of the epidemiology on a broader scale. Moreover, it was conducted in a local area, i.e. Jamnagar.

Jamnagar has a hot and semi arid climate. Studies show that hair fall, is not independent of climatic factors (sunshine hours), and these must be taken into account when assessing the treatment or prevention of hair loss (Courtois M. et al.).

[16] Therefore, for more definite and conclusive results, multi-centric trials with more sample size is advised.

3.

Conclusion Data generated by this study validates the property of Lavana Rasa to cause hair complaints if taken in excess. Similarly dandruff and itching were found to be the major complaints associated with hair fall. Results of the present study showed that Kesharaja Taila was effective on Khalitya by reducing the diffuse hair loss. It was also observed that a highly significant reduction in the mean scores of all chief complaints and subjective evaluation revealed remarkable improvement. The excellent antidandruff action of Kesharaja Taila might have been due to the

synergistic antifungal, anti-inflammatory and local immune-stimulatory actions of its ingredients.

1.

2.

3.

4.

5.

6.

7.

8.

9.

10.

11.

12.

13.

14.

15.

References: Adhirajan N, Ravi Kumar T, Shanmugasundaram N and Babu M. In vivo and in vitro evaluation of hair growth potential of Hibiscus rosa-sinensis Linn. Jour of Ethnopharmac. 2008; 88(2-3): 235-239.

Alastair JJ, Wood MD. Treatment of hair loss.

New Engl J Med. 1999; 241(13): 964-76.

Aldridge RD. Hair loss, Clinical Algorithms.

British Medical Journal 1984; 289 (13): 985-989.

Arote SR, Dahikar SB and Yeole PG. Phytochemical screening and antibacterial properties of leaves of Pongamia pinnata Linn.

(Fabaceae) from India. Afr Jour of Biotech. 2009; 8(22): 6393-6396.

Balakrishnan KP, Narayanaswamy N, Mathews S and Gurung K. Evaluation of some medicinal plants for their dandruff control properties. Int Jour of Pharma and Bio Sci. 2009; B-38-45.

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Ayurvedic terminology in medical terms: · Asthi kshaya: degeneration of bones · Asthivaha: body channels carrying small building blocks for formation of bones · Chintyanaam Atichintanaata: Excessive thoughtfulness/pondering · Kasisa: Ferrous sulphate · Katu: Pungent taste · Kesha Rukshatva: Dryness of hair · Kesha Kathinya: stiffness of hair fibers · Keshabhomi Sweda: perspiration of scalp · Keshabhomi Daha: Burning sensation in scalp · Khalitya: hair fall · Lauha Bhasma: Incinerated Iron · Lavana: Salty · Mala: excretory product · Palitya: Premature graying of hair · Rasavaha Sroto Dushti: Vitiation of bodily channels carrying digested food (chyle) · Shuddha: Processed · Srotodushti: Vitiation of body channels · Swedovaha: body channels carrying sweat · Taila: Medicated oils

Address for correspondence : Dr. Pramod Yadav, Assistant Professor, Department of Rasashastra,1 MSM Institute of Ayurveda, BPSMV, Khanpur Kalan Pin Code ______, Sonepat , Haryana (India) Email: drpramod88@gmail.com

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J Res Educ Indian Med, April-June 2014;XX (2):121-135

THERAPEUTIC VISTAS OF GUDUCHI (Tinospora cordifolia (Willd.)

Miers): A MEDICO-HISTORICAL MEMOIR ROHIT SHARMA,1 HETAL AMIN,2 GALIB3 AND P.K. PRAJAPATI4 Department of Rasashastra and Bhaishajya Kalpana including Drug Research,1,3,4 Department of Department of Basic Principles,2 Institute of Post Graduate Teaching & Research in Ayurveda, Gujarat Ayurved University, Jamnagar - 361008 Gujarat (India) Abstract : Natural products with medicinal value are gaining importance in clinical research as they provide better alternatives, owing to lesser side-effects and low cost than conventional synthetic drugs. Among the vast library of important medicinal plants, Guduchi is immensely valuable in terms of therapeutics and global trade. Scattered information exploring therapeutic potential of Guduchi is accessible and there is need to assemble it. Therefore, an effort is made to assemble the scattered information in prehistoric texts, Brihatrayi, Nighantu and other Ayurvedic treatises along with ethno-botanical and modern evidences highlighting the role of Guduchi in therapeutics. Citations relevant to topic were screened.

Keywords: Ayurveda, Guduchi, Tinospora cordifolia, Brihatrayi, Nighantu

Introduction Guduchi, commonly known as Giloe, in mythological term refers to the heavenly elixir having saved celestial beings from old age and kept them eternally young (Singh SS, 2003).[1] This botanical is a large deciduous perennial climber with large succulent stems and papery bark, sending down long, pendulous fleshy roots as it climbs. It is valued for its huge therapeutic potential thousands of years back in Ayurvedic literature, but modern scientific society is just begin to appreciate the immense clinical potential of it. In present times this drug has been subjected to numerous phytochemicals, pharmacological, pre-clinical and clinical investigations, and large amount of compilations are available on the same (Sinha K et al, 2004).[2] Its therapeutic strength lies in its rejuvenating and strengthening properties while detoxifying and cleansing the whole system, specifically via liver. Since each part of Guduchi has some medicinal property, it is very much commercially exploitable. Present review explores (i) Medicohistorical aspects of Guduchi with its therapeutic 1. Ph.D Scholar

2.

Ph.D Scholar

potentials and (ii) the modern scientific information supporting the same.

Historical background Mythological review It is narrated that, in a historical war between Rama and Ravana, several monkey warriors who supported Rama were killed.

Pleased by the triumph of war and death of Ravana, Lord Indra sprinkled elixir on the dead bodies of the monkeys and provided rebirth.

During the process, where ever the elixir drops have fallen on the earth, Guduchi plants originated (Bhavamishra, 2010).[3] Vedic kala Sayan in Sounakiya Atharvaveda has mentioned that Guduchi is kept in every house to avoid snakes and scorpions. In Kaushika sutra, Guduchi is mentioned by the name â&#x20AC;&#x2DC;Kudruchiâ&#x20AC;&#x2122;.

Samhita kala Charaka Samhita: Total five synonyms, one hundred and eleven (111) references of Guduchi

3. Assistant Professor

4. Professor and HOD

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Sharma et al.

are available and included under seven different Dashemani. The herb is said to possess best Sangrahika and Vibandhaprashamana properties.

Sushruta Samhita: Description of Guduchi is found at 41 places and is included in 9 Gana or groups, based on its diverse therapeutic uses.

Besides, it is also placed in smaller group like Vallipanchmula.

Ashtanga Samgraha: Guduchi is mentioned alone or in combination with other remedial agents in the treatment of Jwara, Prameha, Shlipada etc.

Nighantu kala Dhanvantari Nighantu: Guduchi was mentioned first in one out of seven Vargas. 34 synonyms of it with two varieties like Guduchi and Kanda Guduchi are described.

Kaiyadeva Nighantu: Guduchi is mentioned in Ausadha Varga with its 19 synonyms and varieties as Guduchi and Pinda Guduchi .

Bhavaprakasha Nighantu: Guduchi has been described under Guduchyadi Varga with its mythological origin, 21 different synonyms with Rasayana, Dipana and Balya properties.

Raja Nighantu: Description of two types of Guduchi and Kanda Guduchi with its 31

synonyms and therapeutics utilities has been given.

Shaligrama Nighantu: Nine synonyms of Guduchi and six for Kanda Guduchi have been described in Guduchyadi Gana.

Adhunika kala Dravyaguna Vijnana: The latin name, vernacular names, synonyms, botanical description along with properties and action on different system are described with its therapeutic dose and formulation.

Indian Medicinal Plant: Its botanical description along with different species and medicinal uses are illustrated.

Materia Medica: Detail description of Guduchi along with its use in scorpion bite, is documented.

Pharmacognosy of Indigenous Drugs: The description of latin name, family, parts used, both macro and microscopic structure of the plant with its substitute, adulteration, standardization, physical constant value and flourescence analysis are reported in this text.

Botanical description Botanical name: Tinospora cordifolia (Willd.) Miers ex Hook.f. & Thomas. The genus

Table 1. Synonyms of Guduchi and their interpretation Synonyms Guduchi Amrita Amritavalli, Amritalata Amritakanda, Kandodbhava, Kandarohini Kundali, Kundalani Chakralakshana, Chakralakshanika, Chakrangi Chandrahasa Chhinaruha, Chhinodhava Jwarari, Jwaranashini Tantarika Tantri Vishalya Devanirmita, Surkrita Nagakanya, Nagakumarika Nirjara Madhupaparni Vatsadani Somavalli, Somavallari, Somalatika

Meaning Protecting or guarding the body from the diseases.

Indicating the undying property of plant i.e. even a piece of stem is sufficient for propagation.

Pointing the creeping nature of plant with its Sarvadoshahara and Rasayana like properties.

Illustrating the creeping nature of plant with presence of tubers and properties of Amrita.

Showing the rotatory habit of plant.

Means the wheel-like appearance in transverse section of stem.

Referring the moon like appearance of transversely cut stem.

Regular emergence of plant even if it is cut-off several times.

Showing its antipyretic activity.

Exposing it as protector of health of all family members.

Pointing out its longevity providing properties.

Showing it with unarmed nature.

Dealing with its origin from god.

Exhibiting it revolving nature around the support like cobra.

Demonstrating its undying nature.

Proving the gland dotted nature of leaves which appear like filled with honey.

Elucidating the taste of calves to this plant which will eat this plant mainly.

Showing it as creeper which pacifies thirst, burning sensation etc.

Therapeutic vistas of Tinospora cordifolia (Guduchi)

Tinospora is derived from the Latin word tinnio” and Greek word “spora” means subglobose or ellipsoidal seed. The species is ‘Cordifolia’ where folia means leaves having cordial-heart shape.

Family: Menispermaceae which means drug having moon or crescent shaped seed (Anonymous, 2011).[4] Guduchi in its natural habitat with Principal Botanical parts is illustrated in Figure 1.

Distribution & Habitat It is distributed throughout tropical Indian subcontinent and China, ascending to an altitude of 900 m. from Kumaon eastwards as well as Southwards up to Sri Lanka. It is a fairly common wild plant of deciduous nature and dry forests of most distracts growing over hedges and small trees (Anonymous, 2002).[5] Sanskrit synonyms and their interpretation Different synonyms of Guduchi are described which are related with its mythological origin, morphological characters, propagation, therapeutic efficacy etc (Table 1) (Sharma PV, 2010).[6]

123

(Malayalam), Gulvel (Marathi), Guluchi (Oriya), Gilo (Punjabi), Seendal, Seendil Kodi (Tamil), Siddhilata, Amarlata (Assamese) (Anonymous, 2001).[7] Morphological and therapeutic categorization (Gana and Varga) Acharya have classified the drugs according to their origin, morphology, property, pharmacodynamics and therapeutic values. Each Acharya has adopted different methodology according to his intellectual sense as classified the drugs under different group of drug, named as Dashemani, Gana, Varga, Skandha, etc. These groupings are shown in Table 2.

Energetics Ayurvedic pharmacology (Dravya Guna and Karma) of Guduchi is detailed in Table 3 and is based on biophysical, experiential, inferential and intuitional mechanisms (Sharma PV, 2003).[19]

Vernacular names Heartleaf Moonseed, Tinospora (English), Gulancha (Bengali), Gurcha (Hindi), Garo, Galo (Gujarati), Thippateega (Telugu), Amrutavalli (Kannada), Amrita, Gilo (Kashmiri), Chittamrutu

Based upon these properties, classical texts of Ayurveda have claimed the wide range of therapeutic attributes of Guduchi. With the scrutiny of various verses in different texts, slight difference in views regarding pharmacodynamics properties of Guduchi are noted down as in Table 4 Karma (action) and Rogaghnata (therapeutic indications)

Figure 1: Guduchi in its natural habitat with principal botanical parts.

Figure 2: A twig of Guduchi and its Chief active phytoconstituents.

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Sharma et al.

Table 2. Guduchi in various groups as reported in different texts In Samhita

Charaka Samhita

[8]

Sushruta Samhita[9]

Ashtanga Hridaya[10]

Varga/Mahakashaya Sandhaneeya Triptighna Stanyashodhana Snehopaga Trishnanigrahana Dahaprashamana Vayasthapana Madhura Skandha Tikta Skandha Sirovirechana Vatasanshaman Gana Pittasanshaman Gana Shleshmasanshaman Gana Shodhan Varga Ropana Gana Aragvadhadi Syamadi Patoladi Kakolyadi Guduchyadi Valli Panchmula Shaka Varga Shaka Varga Padmkadi Gana Patoladi Gana Guduchyadi Gana Aragvadhadi Gana Shyamadi Gana In Lexicons

Dhanvantari Nighantu[11] Kaiyadeva Nighantu[12] Bhavaprakasha Nighantu[13] Raja Nighantu[14] Shaligrama Nighantu[15] Priya Nighantu[16] Shodhala Nighantu[17] Nighantu Adarsha[18]

Name used in context Madhuparni

Guduchi

Amrita Guduchi Vatsadani Chhinnaruha Guduchi Amrita Guduchi Chinnaruha Guduchi Amrita Guduchi Amrita Chhinnaruha

Reference Ch. Su.4/5 Ch. Su.4/11 Ch. Su.4/18 Ch.Su.4/21 Ch.Su.4/29 Ch.Su.4/41 Ch.Su.4/50 Ch.Vi.8/139 Ch.Vi.8/143 Ch.Vi.8/151 S.Su.37/7 S.Su.37/8 S.Su.37/9 S.Su.37/12 S.Su.37/24 S.Su.38/7 S.Su.38/29 S.Su.38/33 S.Su.38/35 S.Su.38/50 S.Su.38/73 S.Su.46/270 A.H.Su.6/77 A.H.Su.15/12 A.H.Su.15/15 A.H.Su.15/16 A.H.Su.15/18 A.H.Su.15/45

Guduchyadi Varga Aushadiya Varga Guduchyadi Varga

Pippalyadi Varga Guduchyadi Varga

Table 3. Pharmacodynamic properties of Guduchi Rasa (taste) Guna (quality) Virya (potency) Vipaka (post-digestive effect) Prabhava (specific action) Karma (action) Dosha effect Dhatu (tissue) Srotas (channel)

Tikta (bitter), Kashaya (astringent) Laghu (light), Guru (heavy), Snigdha (unctuous) Ushna (hot potency) Madhura (neutral) Vishaghna (anti-toxic) Agnideepana (increase appetite), Paachana (digestive), Rasayana (rejuvenative), Ayushprada (promotes life) Vayah-Sthapana (anti-ageing), Trishnanigrahan (quenches thirst), Sangrahi (relieve polyuria), Medhya (nerve tonic), Balya (increase stregth), Vrishya (aphrodisiac), Chakshusya (eye tonic).

Tridoshahara (pacify all three aggravated doshas) Plasma, blood, muscle, fat, nerve, reproductive Circulatory, digestive

Therapeutic vistas of Tinospora cordifolia (Guduchi)

Karma denotes action of a drug based on its properties. Various texts have highlighted a number of actions and therapeutic indications of Guduchi, which are detailed in Table 5.

Guduchi in Brihatrayi Brihatrayi (Charaka Samhita, Sushruta Samhita and Ashtanga Hridaya), the prime texts

125

of Ayurveda, contribute number of references pertaining to clinical application of Guduchi.

The herb is mentioned to be used for both external and internal therapeutic purposes under various formulations. Usages of herb in Panchakrma and other procedures are also available.

These citations in Brihatrayi are listed in Tables 6, 7, 8 and 9.

Table 4. Pharmacodynamic properties of Guduchi as per different texts Sr.No. 1.

2.

3.

4.

5.

6.

7.

8.

9.

10.

11.

Classical texts Charaka Samhita Sushruta Samhita Astanga Sangraha Astanga Hridaya Dhanavantari Nighantu Madanpala Nighantu Kaiyadeva Nighantu Raja Nighantu Bhavaprakasha Nighantu Shaligram Nighantu Dravyaguna Vigyanam

Rasa Tikta Tikta Tikta Tikta Tikta, Kashaya Katu, Tikta, Kashaya Tikta, Kashaya, Katu Tikta, Kasaya Katu, Tikta, Kashaya Tikta, Kashaya, Tikta, Kashaya

Guna Guru Guru Guru Laghu Laghu Guru Laghu Guru, Ushna Guru, Snigdha

Vipaka Madhura Guru Katu Madhura Madhura Madhura Madhura Madhura

Veerya Ushna Ushna Sheeta Ushna Ushna Ushna Ushna Ushna Ushna Ushna

Table 5. Various Karmas and Rogaghnata attributed to Guduchi Sr. No. 1.

2.

3.

4.

5.

6.

7.

8.

9.

10.

11.

12.

13.

14.

15.

16.

17.

1.

2.

3.

4.

5.

6.

7.

8.

9.

10.

11.

12.

13.

14.

Karmas Vatahara Amahara Sangrahi Hridya Balya Vahnikrita Vatapittahara Ayushya Medhya Medohara Pittahara Kataraktahara Dipaneeya Rasayani Tridoshahara Vayasthapaniya Raktadoshahara Kamalahara Pramehaghna Kandughana Trishnanigrahana Visarpaghna Kasahara Dahaprashamanam Kushthahara Krimighna Raktarshaghna Bhramahara Chhardighna Panduhara Jwarahara

1 2 + + + + + + + + + + + + + + + + + Rogaghnata + + + + + + + + +

1. Charaka Samhita, 2. Sushruta Samhita, 3. Ashtanga Sangraha, 6. Raja Nighantu, 7. Bhavaprakasha Nighantu, 8. Shaligram Nighantu

3 + + + + + + + + +

4 + + + + + + + + -

5 + + + + + + -

6 + +

7 + + + + + -

8 + + + + + + + + + + + +

+ + + + + +

+ + + + + + +

+ + + + + + + + +

+ + + + + +

+ + + + + + + + +

+ + + + + + + + + + + + + +

4. Dhanavantari Nighantu,

5. Kaiyadeva Nighantu,

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Table 6. Therapeutic usages of Guduchi as prime ingredient in different polyherbal formulations References Formulations Ch. Su. 21/22 Guduchyadi Yoga Ch. Chi. 18/161 Guduchyadi Ghrita Ch. Chi. 24/145 Guduchyadi Yoga Ch. Chi. 28/157 Amritadi Taila Ch. Chi. 29/103 Amritadya Taila Ch. Chi. 29/121 Guduchyadi Taila* Ch. Chi. 30/58 Guduchyadi Kwatha Ch. Chi. 30/59 Guduchyadi Taila Su. Su. 38/48 Guduchyadi Gana Su. Chi. 5/8 Guduchi Kwatha Su. Chi. 9/7 Meshashrungyadi Taila/Ghrita Su. Chi. 27/7 Guduchi Kwatha Su. Chi. 38/47 Guduchyadi Kwatha Su. U. 39/169 Guduchi Shruta Shitakashaya Su. U. 39/174 Guduchi Swarasa Su. U. 39/178 Guduchyadi Kwatha Su. U. 39/213 Guduchi Nimbadhatri Kashaya Su. U. 39/221 Guduchyadi Ghrita Su. U. 39/243 Guduchyadi Ghrita Su. U. 49/24 Guduchi Kashaya As. H. Su. 15/16 Guduchyadi Yoga As. H. Chi. 1/94 Guduchyadi Sneha Yoga As. H. Chi. 7/25 Guduchyadiyukta Bhojana As. H. Chi. 11/12 Swawadi Taila Pana As. H. Chi. 18/6 Duralabhadi Sitakashaya As. H. Chi. 16/53 Guduchi Swarasa As. H. Chi. 22/7 Guduchi Swarasa Shrita Kshira As. H. U. 22/68 Guduchyadi Taila Pana As. H. U. 39/44 Guduchi Swarasa * Guduchi Swarasa is used

Doses and Adjuvants Doses of different dosage forms of Guduchi are mentioned as follows (Anonymous, 2002) [20]: Powder 1-3 masha (3-6g) Decoction 4-8 tola (50-100ml) Satva 5-15 ratti (1-2g) The specific adjuvants are mentioned in Madanpala Nighantu for different disorders, which are as below (Upadhyaya R, 2004) [21]: Vata vikara Ghrita Pitta vikara Sharkara Kapha vikara Madhu Vibandha Guda Vatarakta Erand taila Amavata Shunthi Various formulations (Kalpas) The common and widely practiced formulations of Guduchi are as follows (Mishra S, 2001) [22]: Churna : Rasayana churna, Sudarsana churna Kwatha : Guduchyadi kwatha, Manjisthadi

Therapeutic indications Krisha Chikitsa Kasa Madatyaya Vatavyadhihara (Shreshtha) Vatahara, Kshatakshina, Akshepa etc Vatarakta, Jwara Yoni Parisechana Vatika Yoni roga Deepana, Hrillasa, Arochaka, Pipasa etc Pittanubandha vata Vatakushtha Ayuvardhana Tejovarnabalotsaha Viryagni, Asthapana Jwara Anilakrita Jwara Pittajwarapaha Vishamajwara Kshaya, Shwasa, Kasa, Jirnajwara Jirnajwara, Shopha, Pandu Sannipataja Chhardi Pittashleshma Jwara, Chhardi, Daha etc Jirna jwara Pittaja Madatyaya, Kasa Mutraghata Trishna, Visarpa Halimaka Vatashonita Galaganda Rasayana

kwatha, Punarnavastaka kwatha Arista : Amritarista Ghrita : Guduchi ghrita, Amritadi ghrita, Panchatikta ghrita Taila : Guduchyadi taila Vati : Samsamni vati, Chandraprabha vati Lauha : Guduchyadi lauha Rasa-ausadhi : Gandhaka rasayana, Chandrakala rasa Ethnobotanical and Folklore uses Tribals have their own tradition, beliefs and knowledge about use of natural resources as medicines. Available evidences of folklore and tribal uses are listed in Table 10. (Singh J, 2003).[23] Major phytoconstituents and their biological roles A variety of constituents have been isolated from Guduchi and their wide range of biological activities is summarized in Table 11.[24-50] Chief active phytoconstituents of of Guduchi are dipicted in Figure 2. Various pharmacologically

Therapeutic vistas of Tinospora cordifolia (Guduchi)

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Table 7. Therapeutic usages of Guduchi as ingredient in different polyherbal formulations References Ch. Su. 3/3 Ch. Su. 4/11 Ch. Su. 4/18 Ch. Vi. 8/143 Ch. Chi. 17/93 Ch. Chi. 17/102 Ch. Chi. 18/35 Ch. Chi. 20/31 Ch. Chi. 21/57 Ch. Chi. 21/130 Ch. Chi. 26/57 Ch. Chi. 28/148 Ch. Chi. 28/ 170 Ch. Chi. 29/71 Ch. Chi. 30/53 Ch. Chi. 3/30 Ch. Chi. 3/198 Ch. Chi. 3/202 Ch. Chi. 3/211 Ch. Chi. 3/221 Ch. Chi. 3/266 Ch. Chi. 3/298 Ch. Chi. 6/28 Ch. Chi.7/123 Ch. Chi. 7/152 Ch. Chi. 12/24 Ch.Chi. 12/34 Ch. Chi. 15/190 Ch. Chi. 16/62 Ch. Chi. 16/133 Su. Su. 38/5 Su. Su. 38/29 Su. Su. 38/33 Su. Su. 38/73 Su. Chi. 5/13 Su. Chi. 6/13 Su. Chi. 10/4 Su. Chi. 15/44 Su. U. 39/173 Su. U. 39/186 Su. U. 40/50 Su. U. 40/53 Su. U. 40/62 Su. U. 44/36 As. H. Su. 10/29 As. H. Su. 14/22 As. H. Su. 15/15 As. H. Sha. 2/7

Formulations Aragwadhadi Yoga Truptighna Dashemani Vayasthapana Dashemani Tiktaskandha Nidigdhikadi Yoga Dashamuladi Yoga Kantakari Ghrita Gavedhukamuladi Yoga Mustadi Yoga Mustabhallatakadi Yoga Saptachhadadi Yoga Bala Taila Vrishamuladi Taila Drakshadi Ghrita* Sthiradi Taila Medhya Rasayana Jwaranashaka Kashaya Vishamajwaranashaka Kashaya Shatyadivarga Kwatha Pippalyadya Ghrita Agurvadi Taila Vishamajwarahara Yoga Kaphapramehanashaka Yoga Vatakaphaghnakushta Yoga Mahakhadir Ghrita Vatapittajanya Shothartha Yoga Punarnavadyarishta Panchama Kshara Pratahakalin Yoga Siddha Dugdha Vidarigandhadi Gana Shyamadi Gana Patoladi Gana Vallipanchamula Patoladi Kwatha Bharangyadi Takrakapla Mantha Kalpa Bala Taila Drakshadi Kwatha Saptachchhadadi Kwatha Mustadi Yoga Vachadi Yoga Pathadi Kwatha Drakshadi Yoga Pathadi Yoga Kulatthadi Yoga Patoladi Yoga Ushiradi Yoga

important antioxidants are identified in different parts of Guduchi which are cited in Table 12 (Grover P et al., 2012).[51] Guduchi is able to survive assaults from organisms and environmental stress. Interestingly it is recognized as an adaptogenic plant species which contains

Therapeutic indications Kshudrakushtha, Kilasa, Bhagandara etc Atripti Vayasthapana Pittavikara Shwasa, Hikka Kasa, Hridgraha, Shwasa, Hikka etc Kasa Chhardi Visarpa Visarpa Mutrakriccha Vatavikara Vatavyadhi Vatashonita Yonishula, Hridroga, Gulma, Arsha Memory enhancement Jwara Chaturthaka Jwara Sannipatajwara Jirnajwara Shitajwara Vishamajwarahara Kaphaj Prameha Vatakaphaghnakushta Sarva Kushtha Vatapittajanya Shotha Hridroga, Shwayathu, Pliha etc Grahani Kamala Halimaka Pittanilahara, Shotha, Gulma etc Gulama, Vishapaha, Anaha, Udara etc Pittakapha, Arochaka, Jwara, etc Raktapittahara, Shukradosha etc Vatarakta Arsha Mahakushta Mudhagarbha Vatakrita Jwara Kaphaja Jwara Shulatisara Shulatisara Paittika Amatisara Lagharaka Tiktaskandha Ati Sthaulya Kapha, Pitta, Kushtha, Jwara etc During Pregnancy

Phytoecdysteroids [a class of chemicals that plants synthesize for defence against phytophagous (plant-eating) insects] namely 2deoxy-20-hydroxyecdysone 3-glucoside and 3-epi-2-deoxy-20-hydroxyecdysone (Klein R, 2004).[52]

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Table 7â&#x20AC;Ś.continued References As. H. Chi. 1/46 As. H. Chi. 1/51 As. H. Chi. 1/66 As. H. Chi. 1/154 As. H. Chi. 3/3 As. H. Chi. 16/13 As. H. Chi. 16/43 As. H. Chi. 18/30 As. H. Chi. 19/39 As. H. Chi. 22/14 As. H. U. 22/97 As. H. U. 34/28 As. H. U. 39/104 * Guduchi Swarasa is used

Formulations Mustadi Yoga Pippalyadi Yoga Nagaradi Yoga Triphaladi Yoga Vrishadi Yoga Vasadi Kwath Triphaladi Yoga Devadarvyadi Yoga Khadiradi Yoga Mustadi Kwatha Khudradi Kashaya Kashmaryadi Ghrita Shunthyadi Yoga

Therapeutic indications Jwara Vataja Jwara Vatashleshmottara Jwara Jwara Kasa, Jwara, Aruchi Pandu, Pittastra, Kamala Kamala Visarpa Kushtha Kapholbana Vatashonita Sarva Mukharoga Yonivatavikara Vyadhi, Jara

Table 8. Therapeutic usage of Guduchi in Panchakarma and other procedures References Ch. Su. 2/12 Ch. Chi. 3/246 Ch. Chi. 3/252 Ch. K. 1/25 Su. Su. 25/21 Su. Su. 44/6 Su. Chi. 37/34 Su. Chi. 38/43 Su. U. 39/151 As. H. Chi. 6/14 As. H. Chi. 12/6 As. H. K. 4/1 As. H. K. 4/55 As. H. U. 9/26 As. H. U. 22/78

Compound name Pataladi Yoga Guduchyadi Patoladya Badarashadavetyadi Yoga Guduchi Guduchyadi Yoga Guduchyadi Taila Shampakadi Guduchi Guduchi Swarasa Guduchi Swarasa Baladi Kalka Guduchyadi Yoga Patoladi Kwath Guduchi -Nimba Kalka yukta Taila

Therapeutic usages Anuvasana Basti Niruha Basti Anuvasana Basti Vamana Vellitaka Sivana Karma Virechana Anuvasana & Uttarabasti Asthapana Basti Patra Shaka Virechana Samakshika Bhojana Basti Anuvasana Basti Vamana and Virechana Nasya

Diseases Jwara Jwara Kaphaja Roga Prishta, Grahani etc Jwara Pittaja Chhardi Prameha Sarva Vatavikara Vartma Roga Mukharoga

Table 9. Therapeutic usages of Guduchi in external application References Ch. Su. 3/21 Ch. Chi. 8/71 Su Su.12/26 Su. Chi. 1/115 Su. Chi. 2/74 Su. Chi. 20/50 Su. U. 19/13 As. H. Chi. 19/86 As. H. U. 22/6 As. H. U. 22/78 As. H. U. 34/33 As. H. U. 38/20

Compound name Rasnadi Ghrita Guduchyadi Guduchi Pathadi Yoga Samangadi Taila Kulatthikadi Guduchyadi Ghrita Chitrakadi Yoga Guduchyadi Ghrita Guduchi -Nimba Kalka yukta Taila

Guduchydi Kwatha Palindyadi Yoga

Therapeutic usages Pradeha Parisheka Sweda Patra Achhadana Patradana Ropana Pralepa Prakshalana, Parisheka, Ashyotana

Lepa Abhyanjana Abhyanga Parisechana Lepana

Reported therapeutic attributes The plant is useful in wide range of diseases like fevers, diabetes, dyspepsia, skin diseases etc (Chunekar KC, 2006).[53] The stem is bitter, stomachic, stimulates bile secretion, enriches the blood and useful in jaundice, urinary

Diseases Vatarakta Rajayakshma Atidagdha Kaphaja Vrana Asadhya Valmiki, Agnirohini Nayanabhighata Kushtha Mukharaga Mukharoga Guhyaroga Shopha in Vishadansha

disease and upper respiratory tract infections (Vedavathy S, 1991).[54] Guduchi: A protective herb Besides various protective roles such as immunomodulation, hepatoprotection (Bishayi B

Therapeutic vistas of Tinospora cordifolia (Guduchi)

129

Table 10. Folklore and tribal uses of Guduchi Disease Fever Jaundice, fever, chronic diarrhea, periodic fever Fever Fever Fever Cancer, dysentery, diarrhea, periodic fever Burning (Daha) General debility

Internal usage Mode of application Pills prepared from paste of Guduchi stem and roots of Bhatkataiya (Solanum surattense) Whole plant is used Decoction of stem administered orally Warm juice of root orally Juice or decoction of leaves orally with honey Powdered root and stem bark of Guduchi with milk in cancer. Root decoction for diarrhea and dysentery. Stem decoctions for periodic fever Paste or juice of leaves and Sarshapa beeja churna (mustard seeds) for Daha Stem decoction in morning, empty stomach

Asthma

Powders of Guduchi, Haritaki and Ajwain in equal proportion, orally, once daily, in morning with salt Two drops of leaves juice are dropped in affected ear Paste of Guduchi and 5 seeds of Maricha (Piper nigrum), orally, in morning Stem juice, orally with honey

Skin disease

Stem decoction, orally

Cough Otalgia Leukorrhea

Tribals and areas Baiga, living in interior areas of Naugarh and Chakia blocks of Varanasi, Uttar Pradesh Tribals of Mumbai and adjoining areas, and fishermen along sea cost Tribals of Jammu and Bigwada (Rajasthan) Inhabitants of Bhuvneshwar (Orissa) Local people of Patiala (Punjab) Tribals of Khedbrahma region (North Gujarat) Inhabitants of Banka (Bihar) In Dhanu forest area of Maharashtra, tribes viz.

Agaris, Bhils, Dhodias, Dublas, Khakaris, Thakurs, Vandaris, Vagharis and Varlis Inhabitants of Dhurala (Haryana) Local people of Patiala (Punjab) Local women of Arjunpura (Rajasthan) Local people of Badala (Uttar Pradesh) Inhabitants of Dehrabara Kolaras, Sivpuri district of Madhya Pradesh

External usage Bone fracture

Whole plant is used as plaster and internally

Fracture Emaciation in children Bites of poisonous insects and venomous snakes, eye diseases

Paste of whole plant as plaster Dyed shirt soaked in Guduchi Juice worn daily Paste of Guduchi is applied to bitten part and administered orally. For eye disorders, juice of root is poured as eye drops

et al., 2002),[55] neuroprotection, gastroprotection (Grover JK et al., 2002),[56] osteoprotection (Kapur P et al., 2008),[57] cardioprotection (Rao PR et al., 2005),[58] free radical scavenging (Rawal AK et al., 2004),[59] antioxidant (Stanely M et al., 2001),[60] the plant also provides protection against brain, heart, liver and kidney damage in chronic diseases like diabetes (Prince PS et al., 2004; Prince PS et al., 2005).[61],[62] Studies have also reported its protective role against toxicities induced by heavy metals such as lead (Sharma V et al., 2010).[63] The plant extracts have also demonstrated uroprotective role in Cyclophosphamide induced toxicities by modulating GSH and proinflammatory cytokine levels (Hamsa TP et al.,2012). [64] Guduchi is also is potent radioprotective agent as it ameliorated radiation

Muslim Tribals, Gujjars and Backwals of Rajouri Jammu and Kashmir Mundas of Chhota Nagpur Inhabitants of Banka (Bihar) In certain parts of India

induced testicular injury in experimental studies (Sharma P et al., 2012).[65] Guduchi is well established preventive agent against novel H1N1 flu (Shah A et al., 2013)[66] and is reported to possess anti-HIV properties (Akhtar S, 2010).[67] The constellation of various activities such as antioxidant, immunomodulatory, antiinflammatory, free radical scavenging, hepatoprotective etc plays a role in its protective effects against antitubercular and cytotoxic drugs, and toxins. An n-hexane extract isolated from the plant is proven to exhibit potent antimutagenic activity (Sharma U et al., 2010).[68] Apart from biological roles, Guduchi is also recommended to be used in drinking water treatment process as its biomass has been proven as suitable and low cost adsorbent to reduce fluoride into standard permissible limit (Pandey

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Table 11. Biological activities of major phyto-constituents from different parts of Guduchi Chemical class Alkaloids

Diterpenoid Lactones

Phyto-constituents Berberine, Choline, Tembetarine, Magnoflorine,Tinosporin, Palmetine, Isocolumbin, Aporphine alkaloids, Jatrorrhizine, Tetrahydropalmatine Furanolactone, Clerodane derivatives [(5R,10R)-4R-8R-dihydroxy-2S-R:15,16diepoxy-cleroda-13 (16), 14-dieno-17,12S:18,1S-dilactone], Tinosporon, Tinosporides, Jateorine, Columbin

Plant Part Stem, Root

Whole Plant

18-norclerodane glucoside, Furanoid diterpene glucoside, Tinocordiside, Tinocordifolioside, Cordioside, Cordifolioside Syringin, Syringin-apiosylglycoside, Pregnane glycoside, Palmatosides, Cordifolioside A, B, C, D and E ȕ–sitosterol, į-sitosterol, 20 ȕ-hydroxyecdysone, Ecdysterone, Makisterone A, Giloinsterol

Stem

Sesquiterpenoid Aliphatic compound

Tinocordifolin Octacosanol, Heptacosanol Nonacosan15-one dichloromethane

Stem Whole plant

Others

3-(Į,4-Dihydroxy-3-methoxy-benzyl)-4(4- compounds hydroxy-3-methoxybenzyl)-tetrahydrofuran, Jatrorrhizine, Tinosporidine, Cordifol, Cordifelone, Giloinin, Giloin, N-trans-feruloyltyramine as diacetate, Tinosporic acid

Root, whole Plant

Glycosides

Steroids

Shoot

Biological Activity (In Human being) Anti-viral, Anti-cancer, anti-diabetic, Anti-inflammatory, Neuroprotective, Immunomodulatory, Psychiatric conditions Vaso-relaxant: relaxes norepinephrine induced contractions, inhibits Ca++ influx, anti-inflammatory, anti-microbial, anti-hypertensive, anti-viral, Induce apoptosis in leukemia by activating caspase-3 and bax, inhibits bcl-2 Treat neurological disorders (ALS, Parkinsons, Dementia, motor and cognitive deficits) and neuron loss in spine and hypothalamus, Immunomodulation, Inhibits NF-kB and act as nitric oxide scavenger to show anticancer activities IgA neuropathy, glucocorticoid induced osteoporosis in early inflammatory arthritis, induce cell cycle arrest in G2/M phase and apoptosis through c-Myc suppression. Inhibits TNFĮ,IL-1 ȕ, IL-6 & COX-2 Antiseptic Anti-nociceptive and anti- against 6hydroxydopamine induced parkinsonisms in rats. Down regulate VEGF and inhibits TFN-Į from binding to the DNA Protease inhibitors for HIV and drug resistant HIV

References [24][29]

[30][34]

[35][41]

[42][44]

[45] [46][48]

[49][50]

Table 12. Various antioxidants in different parts of Guduchi Plant Part Fresh Leaves Dry Leaves Fresh Fruits Dry Fruits

Antioxidant (mg/100 g) Ascorbic acid (360); Lycopene (10.43); Carotene (5.24); Anthocyanin (20.296); Phenol (400).

Ascorbic acid (290); Iron (125); Anthocyanin (21.234); Phenol (1240).

Ascorbic acid (40); Lycopene (0.6709); Carotene (6.36); Anthocyanin (19.355); Phenol (560).

Ascorbic acid (3660); Iron (37.5); Anthocyanin (19.061); Phenol (2600).

Table 13. Nutritional composition of Guduchi Constituents Calcium Phosphorous Iron Copper Zinc Manganese

Mineral Analysis* Parts per million (ppm) 102.233±0.0385 24.816±0.1120 26.058±0.0451 3.733±0.0064 7.342±0.0127 12.242±0.0127

*Values are expressed as Mean±SE;

Proximate Analysis* Parameters Weight (w/w%) Moisture 34.390±4.412 Crude Protein 7.740±0.632 Crude fibre$ 56.420±2.211 Nitrogen free extract 26.970±1.012 Nutrient detergent fibre$ 58.310±2.451 Acid detergent fibre$ 54.610±1.861 Acid detergent lignin 30.590±0.741 Hemicellulose 3.700±0.391 Cellulose 23.020±1.183 **All values are expressed on dry matter except moisture $ = fibre and fiber are synonyms

Therapeutic vistas of Tinospora cordifolia (Guduchi)

PK et al., 2012).[69] Thus it also protects against water contamination.

Nutritional values Along with rich protein and dietary fibre contents appreciable levels of major and minor elements namely Zn, Mn, Cl, K, Ca, Ti, Cr, Fe, Co, Ni, Cu, Br, and Sr are found in this herb, that acts as micronutrients for health restorative purpose (Nile SH et al., 2009).[70] Guduchi stem provides sufficient carbohydrate (61.66%), low fat (3.1%) and 292.54 calories per 100 g (Madhav M et al., 2011).[71] Proximate and elemental analysis of its stem revealed rich nutritive composition essential for immunomodulation, body building and health restoration (Table 13) (Mahima et al., 2014).[72]An popular dosage form of Guduchi- ‘Guduchi Satva’ is also reported to possess rich nutrients viz. fat, protein, dietary fibres, energy contents, Ca, Fe as 0.14 g, 0.64 g, 0.16 g, 288.8 cal, 70 mg, and 9.7 mg per 100 g respectively (Geeta K et al., 2013).[73] Desirable Drug Interactions Although, extensive works have been conducted on this herb, no negative herb-drug interactions are reported so far. Concurrent administration of TC with metformin showed beneficial pharmacokinetic as well as pharmacodynamic interaction leading to enhanced antihyperglycemic and antihyperlipidemic activity (Patwardhan B, 2012).[74] The drug interaction study of aqueous extract of TC with gliclazide was conducted in normal and diabetic rats based on pharmacodynamic (blood glucose) response in 12h. The extract improved the

hypoglycaemic activity of gliclazide and shown synergistic action (Raju MG et al., 2014).[75] Plant alkaloid Berberine is reported to boost the effects of metformin and 2,4-thiazolidinedione (THZ), and can partly replace the commercial drugs, which could lead to reduction in toxicity and side effects of the latter (Prabhakar PK et al., 2009).[76] In Ayurveda, decoction of TC stem is used as a medium of ‘Shodhana’ process (relates to combining a substance with another substance to enhance its activity and to help counter some of its unwanted effects) to purify Guggul (Commiphora wightii), which is an vital component of various Ayurvedic antidiabetic formulations. TC enhanced the activity of Guggul.

When used alone, the effect of Guggul was significantly less. Use of Guduchi combinations has a potential basis for clinically desirable drug interactions (Kamble et al., 2008; Caranasos et al., 1985).[77], [78] Toxicity and Safety concerns Although, extensive works have been conducted on this herb, no conspicuous information on toxicity is available so far. The herb is considered to be safe in dosage mentioned (Anonymous, 2003).[79] Pharmaceutical products of Guduchi and their biological roles Using various potent chemical compounds from this botanical, various pharmaceutical market products have been produced by the different companies which are enlisted in Table 14.

Table 14. Various valuable economic products of Guduchi Name of Market product Shila Pravang Guduchi Tablets Madhu Mehari Safe Herbs Mussaffen Rebuild Septilin Tonplex Joint & Muscle Excellence Tablets Natadadrol Brave Heart Capsule Cirrholiv capsules Cirrholiv-ds syrup

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Biological role Premature ejaculation, erectile dysfunction, to enhance the sexual stamina General infections, immune disease, Hepatitis, Arthritis and anti- cancerous Cures dryness of mouth, numbness, debility, relieves frequent urination, fatigue, excessive thirst and maintains the blood sugar Cures Anemia, vaginal discharge and sexual disabilities Blood purifier and anti-allergic Anti- stress and anti- oxidant Treats upper respiratory tract infection Increases immunity and vitality Eliminate the toxins of joints Potent muscle-building androgen Hypolipidemic, diuretic Hepatoprotective Hepatoprotective

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Threats to this Botanical Due to immense medicinal utilities and global high demand, this plant has been overexploited by pharmaceutical companies and folk people for traditional remedies that have led to the acute scarcity of this plant. Guduchi has been listed amongst 29 highly prioritized medicinal plants of agro climatic zone 8 (Rajasthan, U.P. and M.P.) of India as identified by National Medicinal Plant Board, New Delhi, Government of India. This plant has also been listed in 178 medicinal plant species in high Volume Trade by NMPB, New Delhi, India (National Medicinal Plant Board).[80] More initiatives are needed for large scale planned cultivation of the plant to meet the needs.

Conclusion Present review spotlights the therapeutic importance of Guduchi from Ayurvedic perspective which is now validated by contemporary evidence based studies. Existing literature spotlights the preventive, promotive and curative aspect of Guduchi; proving it an ancient elixir with modern cure. However, the mechanistic studies and application in clinical studies are still lacking. Guduchi imbibes a tremendous quantifiable potential and deserves a special attention of scientific fraternity to explore its practical clinical applications. As the global scenario is now changing towards the use of non-toxic herbal products having traditional medicinal usage, development of modern drugs from Guduchi considering Ayuveda concepts should be encouraged to combat various ailments.

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Kapil A, Sharma S. Immunopotentiating compounds from Tinospora cordifolia. J Ethopharmacol 1997; 58:89-95.

Chen S, Wu K, Knox R. Structure-function studies of DT-diaphorase (NQO1) and NRH: Quinone oxidoreductase (NQO2). Free Radic Biol Med 2001; 29: 276-284.

Badwin AS. Control of oncogenesis and cancer therapy resistance by the transcription factor NFkappa B. J of Clin Invest 2001; 107:241-246.

Yang JH, Kondratyuk TP, Marler LE, Qiu X, Choi Y, Caoh et al. Isolation and evaluation of kaempferol glycosides from the fern neocheiropterispalmatopedata. Phytochemistry 2010; 71:641-647.

Kim SK, Kim HJ, Choi SE, Park KH, Choi HK, Lee MW. Antioxidative and inhibitory activities on nitric oxide (NO) and prostaglandin E2 (COX-2) production of flavonoids from seeds of prunustomentosa Thunberg. Arch Pharm Res 2008; 31:424-428.

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Sundarraj S, Thangam R, Sreevani V, Kaveri K, Gunasekaran P, Achiraman S et al. Sitosterol from acacia nilotica L. induces G2/M cell cycle arrest and apopyosis through c-Myc suppression in MCF-7 and A549 cells. J Ethnopharmcol 2012; 141:803-809.

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Wang T, Liu YY, Wang X, Yang N, Zhu HB, Zuo PP. Protective effects of octacosanol on 6hydroxydopamine-induced Parkinsonism in rats via regulation of ProNGP and NGF signalling.

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Thippeswamy G, Sheela ML, Salimath BP. Octacosanol isolated from Tinospora cordifolia downregulates VEGF gene expression by inhibiting nucular translocation of NF<kappa>B and its DNA binding activity. Eur J Pharmcol 2008; 588:141-150.

Ghosh AK, Chapsal BD, Webar IT, Mitsuya H. Design of HIV protease inhibitors targeting protein backbone: An effective strategy for combating drug resistance. Acc Chem Res 2008; 41:78-86.

Mukherjee R, De-UK, Ram GC. Evaluation of mammary gland immunity and therapeutic potential of Tinospora cordifolia against bovine subclinical mastitis. Trop Anim Health Prod 2010; 42:645-651.

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Bishayi B, Roychowdhury S, Ghosh S, Sengupta M. Hepatoprotective and Immunomodulatory properties of Tinospora cordifolia in CCl4 intoxicated mature albino rats.

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Kapur P, Jarry H, Wuttke W, Pareira BM, Seidlova-Wuttke D. Evaluation of the antiosteoporotic potential of Tinospora cordifolia in female rats. Maturitas 2008;59:329-38.

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Hamsa TP, Kuttan G. Tinospora cordifolia ameliorates urotoxic effect of cyclophosphamide by modulating GSH and cytokine levels. Exp Toxicol Pathol 2012;64(4):307-14.

Sharma P, Parmar J, Sharma P, Verma P, Goyal PK. Radiation-induced testicular injury and its amelioration by T. cordifolia (An Indian Medicinal plant) extract. Evid Based Comp Altern Med 2012; 643-647.

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Pandey PK, Pandey M, Sharma R. Defluoridation of Water by a Biomass: Tinospora cordifolia.

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Address for correspondence: Dr. Rohit Sharma, Ph.D. Scholar, Department of Rasashastra and Bhaishajya Kalpana including Drug Research, IPGT & RA, Jamnagar â&#x20AC;&#x201C; 361008 Gujarat (India) Email: dhanvantari86@gmail.com

J. Res. Educ. Indian Med., April-June, 2014; Vol. XX (2)

Announcement

CONFERENCES AND FORTHCOMMING EVENTS

International Conference

Recent Advances on the Role of Basic Sciences in Ayurvedic Medicine 18-19 October, 2014 Proposed Venue : Banaras Hindu University, Varanasi (India) Conference Objectives: The â&#x20AC;&#x153;International Conference on Recent Advances on the Role of Basic Sciences aims to bring together leading academic scientists, researchers and research scholars to exchange and share their experiences and researches about the scientific research work done in different disciplines related to Ayurvedic Medicine. It also provides the premier interdisciplinary forum for researchers, practitioners and educators to present and discuss the most recent innovations, trends, concerns and practical challenges encountered including the solutions adopted. The board areas which will be covered in this conference includes1.

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Need of Research in Ayurveda Pharmaceutical sciences and Pharmacology in Ayurvedic drug science Leads for drug development from Ayurvedic medicine Agro-technology in Ayurveda Precedence regarding scope and outcome of interdisciplinary research Understanding Pathology and pathogenesis: Ayurvedic wisdom Biotechnology and Ayurveda Molecular Biology and Ayurveda Biochemistry and Microbiology in Ayurveda Latest developments in research and treatment, and translating them into clinically useful knowledge Traditional perspectives in Nutrition and Dietetics Ayurveda and Modern Biology

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Pharmacological research in Ayurveda Scope of Biomedical Engineering in Ayurveda Clinical trials and pharmaco-vigilance in Ayurveda Behavioral sciences / Psychology in Ayurveda Recent contributions of Ayurvedic herbs and natural products to medicine and healthcare systems Recent advances in analytical techniques for Ayurvedic herbal drug and product research Public perception and uses of Ayurvedic medicine Research on yogic science in Ayurveda Recent researches in different disciplines of Ayurveda

Panel Discussion: 1.

Evidence based research in Ayurveda: Need of Time 2.

Scope of Interdisciplinary Research in Ayurveda

For more information and to submit abstracts contact: e-mail: mrfsw_kvns@yahoo.com.

Enquiries: Conference Secretary, Ratnesh Kumar Rao, Mahima Research Foundation & Social Welfare, 194, Karaundi, PO: BHU, Varanasi - 221005 UP (India) Cell : (+91) 9335094154

Final Abstract Submission Deadline to Qualify for Regular Registration: 10 October 2014

ORGANIZED

BY

MAHIMA RESEARCH FOUNDATION AND SOCIAL WELFARE

J Res Educ Indian Med, April-June 2014; Vol. XX (2)

Announcement

CONFERENCES AND FORTHCOMING EVENTS

NATIONAL CONFERENCE ADVANCES IN AYURVED HEALTH CARE CHALLENGES IN 21ST CENTURY www.paprolaayurved.org

12th (Friday) – 13th (Saturday) September, 2014 Rajiv Gandhi Govt. Post Graduate Ayurvedic College, Paprola - 176115 Dist. Kangra, Himachal Pradesh (India)

The organization committee is pleased to announce that Rajiv Gandhi Govt. Post Graduate Ayurvedic College, Paprola - Kangra, H.P. (India) is going to organize a National Conference on the theme “Advances in Ayurved - Health Care Challenges in 21st Century” with following objectives: 1.

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To interact, translate and disseminate the recent researches and advancements of Ayurveda for better use in different fields of clinical practices in Ayurveda.

To encourage the researchers, academicians and P.G. students to do evidence based researches.

To make the participants aware of health challenges of 21st century.

To complement the mainstream medicine in providing complete healthcare to the society in terms of preventive and curative health care.

Call for Papers: Proposals for paper presentations, poster sessions, roundtables or colloquia are invited to the conference, addressing the Theme of the conference Original research / review papers related to the theme of the conference are invited for presentation purposes from Teachers/ Researchers /Scientists /P.G. students. Soft copy of full papers (typed in Times New Roman (12 point English), Kruti Dev 010 (Hindi/Sanskrit) in double space with abstracts (not exceeding 200 words), should be sent by e-mail to The Chairman Scientific Committee (dryks2@gmail.com)or Organising Secretary (profsanjeevhp@gmail.com). Papers should reach before 20th August, 2014. A Souvenir of selected papers and abstracts will also be published.

CONFERENCE FORMAT: 2 days programme with 6 plenary sessions, Poster presentations, Case presentations, Photographs presentation, Documentary Presentations and Panel Discussions.

Registration Fees and Early Discount: On or before 14 th Aug., 2014

After 14 th Aug., 2014

Spot Reg.* 12 th Sept., 2014

Delegates (Academia) : 700/1000/1000/Delegates (PG / Ph.D. Students): 500/700/700/Delegates (Pharmaceuticals) : 1000/1500/1500/The registration fee includes conference kit, breakfast, lunch, dinner and entry to cultural programme Registration fees can be paid through DD drawn in favour of “Organizing Secretary, National Conference on Ayurveda, R.G.G.P.G.Ayu.College, Paprola (HP)”

TOY TRAIN

PATHANKOT TO P APROLA

CONFERENCE SECRETARIAT: PROF. SANJEEV SHARMA, RAJIV GANDHI GOVT. POST GRADUATE AYURVEDIC COLLEGE, PAPROLA-176115 KANGRA (H.P.) MOBILE (+91) 9418079691 e-mail: profsanjeevhp@gmail.com

J Res Educ Indian Med, April-June 2014; Vol. XX (2)

Announcement

CONFERENCES AND FORTHCOMING EVENTS

7–9 November 2014 Venue: PRAGATI MAIDAN, NEW DELHI (INDIA)

Themes for submitting Oral and Poster Presentations 1. Basic Research - Pharmaceuticals 2. Basic Research - Fundamentals 3. Basic Research - Medicinal Plants 4. Basic Research - Pre Clinical 5. Basic Research - Others 6. Clinical Research - Mind-Body Interventions 7. Clinical Research - Manual Medicine 8. Clinical Research - Whole Systems 9. Clinical Research - Natural Products 10. Clinical Research - Integrative Medicine 11. Clinical Research - Practice Outcomes 12. Clinical Research - Others 13. Educational Research 14. Public Health Services 15. Research Methodol Important email-IDs to remember: General Information/enquiry : info@ayurworld.org IDA : ida@ayurworld.org Abstracts/Papers : papers@ayurworld.org AROGYA Expo : arogya@ayurworld.org

Scientific Workshops 1. Pharmaceutical Developments 2. Clinical Interventions 3. Research Methodology 4. Basic Science 5. Public Health 6. Educational Research 7. Ayurvedic Diagnostics

Call for papers Dates to remember: - Submission of abstracts 30 June 2014 - Confirmation of abstract acceptance 20 August 2014 - Full paper and ppt file submission 20 September 2014 - Poster submission 20 September 2014 - The Congress 7-9 November 2014 For details on research themes, please Visit www.ayurworld.org for updates.

Registration can either be done online at www.ayurworld.org or forward duly filled registration form along with requisite amount by Demand Draft/Cheque favouring ‘6th World Ayurveda Congress’ to the WAC SECRETARIAT, address given below: Note: No accommodation will be provided by WAC to foreign delegates registering for International Delegates’ Assembly (IDA). However, WAC will assist them in getting accommodation at a negotiated rate. Indian delegates who have opted and paid for accommodation will be provided with the same from the evening of 6th November to the evening of 9th November 2014.

The registration fee includes congress kit, breakfast, lunch, dinner and entry to the cultural programme for all the days of the Congress for which the applicant has registered and entry pass for the AROGYA Expo.

WAC SECRETARIAT: WORLD AYURVEDA FOUNDATION, 107/1, MARGOSA ROAD BETWEEN 13TH & 14TH CROSS MALLESWARAM, BENGALURU - 560 003 KARNATAKA, INDIA.

Volume XX : 2

ISSN 0970-7700

April-June 2014

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Vedanta Ayurveda

JREIM Regional Office (Delhi):

Vedanta Ayurveda 195, First Floor, West End Marg, Saidulajab New Delhi - 110030 (India) Mobile : 9811635915, 9873999150 Telefax : 95-11-29536209

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