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

Abstract

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.