Randomized Clinical Trial of an Ayurvedic Formulation, BV-7310 in Alcoholic Liver Disease

Alcoholic liver disease (ALD) is caused by excessive intake of alcohol for many years. The incidence is as high as 25% in the United States, India and several other countries. The disease spectrum varies from fatty liver in initial stages, to hepatitis and finally cirrhosis. Untreated ALD can be fatal. Yet the options for prescription drugs are limited, and not easily available or affordable to the masses worldwide. BV-7310 contains herbal extracts of Phyllanthus niruri, Tephrosia purpurea, Boerhavia diffusa and Andrographis paniculata. The individual plants are known hepatoprotective agents in Ayurveda. The objective of this study was to investigate the safety and efficacy of BV-7310, a proprietary combination standardized formulation, in subjects with ALD. A multi-centric, double-blind, placebo-controlled, randomized study of 61 subjects was conducted for a period of 12 weeks. Subjects on BV-7310 showed improvement in clinical features of ALD as compared to placebo, including reduction and normalization of transaminases. BV-7310 also reduced bilirubin levels to normal, showing improvement in the detoxifying and excretory capabilities of the liver. No significant adverse events were seen in the treatment group. Based on the data shown, BV-7310 shows promise as a safe and effective hepatoprotective in patients of ALD.

Factors associated with drug resistance in pulmonary tuberculosis.

BACKGROUND: Drug-resistant tuberculosis is becoming a formidable foe for the mankind as it is difficult to manage. The present study was aimed at studying the factors associated with drug resistance in tuberculosis. METHODS: One-hundred and nine patients from whom mycobacterial growth was obtained on culture were studied. RESULTS: Treatment default was found to be the most important factor associated with drug resistance. Forty-five of the 48 isolates from patients with history of default showed drug resistance. Travel to a different place was the reason for default in 19 of 45 patients with drug resistance. Symptom relief in 12, cost of treament in two and adverse drug effect in 12 patients were the other commonly observed reasons for default. A history of relapse was also found to be associated with drug resistance. Nineteen of the 34 isolates obtained from these patients showed drug resistance. In contrast, drug resistance was seen in only four of the 27 new, untreated patients with mycobacterial growth. CONCLUSIONS: Drug-resistant tuberculosis is a major problem in the control of tuberculosis. Its resurgence should be controlled by scrupulously monitoring and ensuring patient compliance.