original study The immunoreactive phase is mostly seen in adults, with patients having elevated liver enzymes and high levels of viral DNA. The immunotolerant phase is usually seen in children who are infected at birth. They have normal liver enzymes, despite having very high levels of viral replication. The immunotolerant phase may change into the immunoreactive phase. The latent period may be 20-30 years for those who are infected at birth and much shorter for those who have been infected in adolescence or adulthood.10 Seroconversion from HBeAg-positive to HBeAg-negative and hepatitis B e antibody (HBeAb)-positive states are followed by biochemical, biological and histological resolution.11 In most patients, this is a transient phase to the inactive carrier state. The biochemical, virological and histological abnormalities will persist in 1-5% of patients in spite of seroconversion. This group of patients is called HBeAg-negative CHB. Although CHB infection is highly preventable through vaccination, once it has been established, the sole option for long-term liver disease is treatment. The goals of treatment are sustained viral suppression, normalization of serum glutamic pyruvic transaminase (SGPT) levels and improvement in liver histology leading to long-term reduction in the risk of cirrhosis and hepatocellular carcinoma.12 Ongoing therapies of hepatitis B are interferon, lamivudine and most recently adefovir dipivoxil, have limited long-term efficacy. Improvement in treatment options will reduce morbidity and mortality for chronically infected individuals.13 Ayurveda, an indigenous system of medicine in India, has a long tradition of treating liver disorders with plant drugs. In the present study, Liv.52 HB capsule was evaluated for its efficacy and safety in management of CHB. It is a herbal formulation consisting of 125 mg each of hydroalcoholic extracts of the herbs Cyperus rotundus and Cyperus scariosus. Aim of the Study The present study was planned to evaluate the clinical efficacy and safety of Liv.52 HB capsules in the treatment of CHB. Study Design A double-blind, randomized and placebo-controlled clinical study conducted at Medical College, Kolkata, India. The study protocol, case report forms, regulatory 60
clearance documents, product-related information and informed consent form were submitted to the ‘Institutional Ethics Committee’ and were approved by the same. Material and Methods Inclusion Criteria
Patients with positive HBsAg for at least six months. Patients willing to give informed consent. The SGPT levels of these patients should be within six times the upper limit of the normal at the screening visit.
Exclusion Criteria
Patients with severe decompensated liver disease (defined by serum albumin ≤36 g/dl, bilirubin ≥15 g/dl, prothrombin time ≥2 second prolonged or a history of ascites, variceal hemorrhage or hepatic encephalopathy) and pancytopenias (defined as hemoglobin <11 g/dl, white cell count <4,000/mm3). Co-infection by hepatitis C virus, history of hepatocellular carcinoma, severe hypertension, serious cardiac failure of Grade III or more, renal failure, endocrine disorders (hyperthyroidism, hypogonadism or Cushing’s syndrome), patients on corticosteroids, methotrexate or heparin, diabetes, bone malignancy with pathological fractures. Patients with a history of using interferon or antiviral agents. Women of childbearing age not willing to follow the adequate contraceptive method and lactating women.
Study Procedure
A total of 28 male and female patients aged between 18-65 years were recruited. At the initial randomization visit, a detailed medical history and symptomatic evaluation was done, to score the severity and grading of symptoms such as icterus for evidence of clinical jaundice, anorexia, nausea and vomiting, fatiguability and weight loss. All the patients were routinely screened and subjected to biochemical investigations: Total bilirubin, serum glutamic oxaloacetic transaminase (SGOT) and SGPT, serum alkaline phosphatase (ALP) and total proteins. Clinical Indian Journal of Clinical Practice, Vol. 22, No. 2, July 2011