PregaNause Information Catalog

Information Catalog

Contents PregaNause™.................................................................................................................3 Dosage............................................................................................................................3 Directions......................................................................................................................4 Ingedients.....................................................................................................................5 Zingiber Officinale (Gingerol 20%)..................................................................5 Pyridoxine HCL (Vitamin B6).............................................................................7 Citrus Lemon (Lemon Bioflavonoids Extract 35%)............................8 References....................................................................................................................10

2

w w w. p r e g a n a u s e . co . z a

PregaNause™ PregaNause™ provides support for pregnant women suffering from nausea, dizziness and vertigo. PregaNause™ can also be used by men, women, adults and children for nausea, motion sickness, post-operative nausea and digestive nausea. PregaNause™ is non-sedative, sugar free, lactose free and diabetic friendly.

Morning sickness also sometimes referred to as pregnancy induced nausea and vomiting can occur any time of the day and normally occurs within the first trimester of pregnancy (Ding, Leach, & Bradley, 2012). Motion sickness refers

to the alteration of the vestibular system and can be caused by movement in cars, boats, planes and other types of moving objects (Nunes, et al., 2020). This causes symptoms such as nausea and vomiting, dizziness and sweating to name a few (Nunes, et al., 2020).

Other phenomenon’s that cause nausea and vomiting include post-operative nausea as well as digestive nausea.

Dosage Ingredients

Per Capsule

Zingiber Officinale (Gingerol 20%)

50 mg

Citrus Limon (Lemon Bioflavonoids Extract 35%)

15 mg

Pyridoxine (Vitamin B6)

2.5 mg

3

Directions Patients in the 1st trimester of pregnancy: Take 1 capsule 3 times per day as needed (Do not exceed 4 capsules per day). Recommended to be used chronically throughout the first trimester.

Adults and children 12 years and older: Take 1-2 capsules 3 times per day as needed (Do not exceed 8 capsules per day).

Children aged between 6-12 years: Take 1 capsule 3 times per day as need. (Do not exceed 4 capsules per day).

4

w w w. p r e g a n a u s e . co . z a

Ingredients Zingiber Officinale (Gingerol 20%) Ginger is widely known for treating conditions associated with nausea and vomiting such as morning sickness, gastrointestinal symptoms, postoperative nausea and morning sickness (Nunes, et al., 2020). Zingiber Officinale is part of the Zingiberacaea plant family and studies have shown that gingerol can inhibit 5HT3 and acetylcholine receptors (both increase gut motility and gut secretion) (Lete & Allue, 2016). The aromatic, spasmolytic, carminative and absorbent characteristics of ginger indicates that it has direct effects on the gastrointestinal tract meaning that is relieves nausea and vomiting (Ernst & Pittler, 2000). Ginger acts directly on the digestive tract and avoids the central nervous system side effects that central acting antiemetics commonly have (Bryer, 2005).

In a study of 174 participants, the effects of gingerol were tested on motion sickness and the results indicated that

(Ding, Leach, & Bradley, 2012). The trials concluded that ginger was more effective in reducing nausea and vomiting compared to the placebo (Ding, Leach, & Bradley, 2012). Furthermore, another study showed that 82.8% of women reported that ginger showed an improvement in their nausea symptoms compared to the other controlled group (Ensiyeh & Sakineh, 2009).

A systematic review of six clinical trials also proved the hypothesis that ginger helped with nausea and in particular morning sickness, seasickness and chemotherapy-induced nausea (Ernst & Pittler, 2000).

Ginger is a safe and effective component and a daily dose of up to 1000mg is considered safe (Ozgoli, Goli, & Simbar, 2009). Within a study of 67 pregnant women that complained of nausea and vomiting, half were assigned a placebo and half were assigned 250mg

gingerol showed an improvement in the motion sickness of the participants (Nunes, et al., 2020). Ginger has been shown to be a safe and effective treatment for pregnancy-induced nausea (Morning sickness) (Ding, Leach, & Bradley, 2012).

Four randomised controlled trials were evaluated to look at the effects of ginger on pregnancy induced nausea. In the trial ginger was taken orally as an alternative to a placebo

ginger capsules for 4 days (Ozgoli, Goli, & Simbar, 2009). The patients that used the ginger showed an 85% improvement rate and vomiting frequency also decreased by 50% (Ozgoli, Goli, & Simbar, 2009).

5

6

w w w. p r e g a n a u s e . co . z a

Pyridoxine HCL (Vitamin B6) Vitamin B6 is a water-soluble compound and has different forms such as pyridoxine, pyridoxal and pyridoxal phosphate (Matok, et al., 2014).

Vitamin B6 has shown to have antiemetic effect (decreases nausea and vomiting). Several studies were conducted in order to investigate this. A study where 131 women received vitamin B6, these women showed a significant decrease in nausea (Matok, et al., 2014). In a study of 59 women, 31 patients received 25mg of Vitamin B6 every 8 hours and 28 patients received a placebo- the results indicated that less nausea and vomiting was observed in the group who received vitamin B6 after 72 hours compared to the placebo group (Sahakian, Rouse, Sipes, Rose, & Niebyl, 1991).

Many studies suggest that ginger and vitamin B6 have the same results with regards to reduction of nausea and vomiting (Smith, Crowther, Willson, Hotham, & McMillian, 2004). In a study of 291 women where half took ginger and the other half vitamin B6; the results showed that both had similar results with regards to the reduction of nausea and vomiting (Smith, Crowther, Willson, Hotham, & McMillian, 2004).

Another study that was done over a 3-month period, assessed 70 women who either received ginger or vitamin b6, and the results showed that ginger effectively reduced nausea and both were equally effective by decreasing the number of vomiting episodes in early pregnancy (Ensiyeh & Sakineh, 2009).

7

Citrus Lemon (Lemon Bioflavonoids Extract 35%) Studies suggest that lemon bioflavonoids can decrease dizziness and help patients struggling with vertigo (the sensation that you, or the setting around you, is moving or spinning) (Chiarella, et al., 2021). A nutraceutical that contains a combination of ginger, lemon and vitamin B6 and other ingredients had a positive effect on people that struggled with vertigo and dizziness (Chiarella, et al., 2021).

8

w w w. p r e g a n a u s e . co . z a

9

References Bryer, E. (2005). A Literature Review of the Effectiveness of Ginger in Alleviating Mild-to-Moderate Nausea and Vomiting of. Journal of Midwifery & Women›s health, 50(1), e1-e3.

Chiarella, G., Marciano, G., Viola, P., Palleria, C., Pisani, D., Rania, V., . . .

Gallelli, L. (2021). Nutraceuticals for Peripheral Vestibular Pathology: Properties, Usefulness, Future Perspectives and Medico-Legal Aspects.

Nutrients, 13(10), 3646. doi:10.3390/nu13103646 Ding, M., Leach, M., & Bradley, H. (2012). The effectiveness and safety of ginger for pregnancy-induced nausea and vomiting: A systematic review.

Women and Birth, 26, 26-30.

Ensiyeh, J., & Sakineh, M. (2009). Comparing ginger and vitamin B6 for the treatment of nausea and vomiting in pregnancy: a randomised controlled trial. Midwifery, 25, 649-653.

Ernst, E., & Pittler, M. (2000). Efficacy of ginger for nausea and vomiting: a systematic review of randomized clinical trials. British Journal of anaesthesia, 84(3), 367-371.

Lete, I., & Allue, J. (2016). The Effectiveness of Ginger in the Prevention of Nausea and Vomiting during Pregnancy and Chemotherapy. Integrative Medicine Insights, 11, 11-17. doi:10.4137/IMI.S36273 Matok, I., Clark, S. C., Umans, J., Hankins, G., Mattison, D., & Koren, G. (2014). Studying the antiemetic effect of vitamin B6 for morning sickness: Pyridoxine and pyridoxal are prodrugs. The Journal of Clinical Pharmacology, 54(12), 1429-1433. doi:10.1002/jcph.369

10

w w w. p r e g a n a u s e . co . z a

Nunes, C., Rodriques, C., Cardaso, C., Cytrynbaum, N., Kaufman, R., Rzetelna, H., . . . Geller, M. (2020). Clinical Evaluation of the Use of Ginger Extract in the Preventive Management of Motion Sickness. Current Therapeutic Research, 1-7.

Ozgoli, G., Goli, M., & Simbar, M. (2009). Effects of Ginger Capsules on Pregnancy, Nausea, and Vomiting. The Journal of Alternative and Complementary Medicine, 15(3). doi:10.1089/acm.2008.0406 Sahakian, V., Rouse, D., Sipes, S., Rose, N., & Niebyl, J. (1991). Vitamin B6 is effective therapy for nausea and vomiting of pregnancy: a randomized, double-blind placebo-controlled study. Obstetrics and Gynecology, 78(1), 33-36.

Smith, C., Crowther, C., Willson, K., Hotham, N., & McMillian, V. (2004). A Randomized Controlled Trial of Ginger to Treat Nausea and Vomiting in Pregnancy. Obstetrics & Gynecology, 103(4), 639-645. doi:10.1097/01.

AOG.0000118307.19798.ec

Quality and Product Development DB Pharmaceuticals is a registered, Grade A certified pharmacy under the South African Pharmacy Council (SAPC) – with registration number Y60310.

The manufacturing facility is licensed with the South African Health Products Regulatory Authority (SAHPRA) which is only granted after a positive GMP inspection by the regulator.

We are fully compliant with the current South African Health Products Regulatory Authority (SAHPRA) and the Medicines and Related Substances Control Amendment Act, No. 19 of 1976 requirements for Category D – Complementary Medicines.

The manufacturing plant is further accredited by the South African Pharmacy Council as a pharmacy owner, grading certificate Grade A, and recording of a pharmacy.

DB Pharmaceuticals welcomes SAHPRA’s approach to regulate the manufacture and sale of Complementary Medicines and Health Supplements which we believe will result in a safer, more efficient experience for patients who seek quality natural health products.

Certification of the manufacturing plant also includes a Department of Health Manufacturing Pharmacy certificate and a Certificate of Acceptability for Food Premises and is registered with the South African National Department of Health.

All our products old and new have been developed by our two in-house responsible pharmacists who have 37 years of experience between them.

Once products and formulations have been researched and developed the formulation is sent to our team of specialist formulary pharmacists at the manufacturing site who review and test formulations against recent research to ensure safety, quality, and efficacy.

11

36 Sovereign Drive, Route 21 Corporate Park, Irene, Centurion Gauteng, South Africa 0062 info@preganause.co.za www.preganause.co.za Helpline: 012 111 8313 Like & Follow us: