Efficacy and safety of hepano tablet in liver disorder patients with abnormal liver function test: A randomized active controlled prospective clinical study

Abstract

Objective: Hepano Tablet is an Ayurvedic herbal formulation studied in pre-clinical models for safety and hepatoprotective efficacy. The current study was a randomized, active controlled, multicentre, prospective clinical study that aimed to evaluate hepatoprotective efficacy and safety of Hepano Tablets. Materials and Methods: Male and female liver diseases patients (18-65 years) with abnormal liver function tests were randomized to receive two tablets twice daily orally of either Hepano or a marketed comparator for 8 weeks with follow up at day 7, 14, 28 & 56 during treatment period and thereafter at day 84. Results were assessed from baseline to end of treatment basis changes in liver function tests and improvement in clinical symptoms of icterus in both the groups. Safety was assessed at all the visits basis changes in laboratory parameters and adverse event reporting for all cases who took at least one dose of the study drug. Results: Hepano Tablet and marketed comparator showed significant improvement in Liver functions - Serum Aspartate transaminase (AST), Alanine transaminase (ALT) and Total, Direct and Indirect Bilirubin Levels and a significant reduction in clinical symptoms of icterus that was comparable at all the visits. Conclusion: Hepano Tablets can significantly improve Liver Function Tests and clinical symptoms in liver disease patients and could be consumed safely.