Evaluation of Efficacy and Safety of Test Drug in Liver Disorder Subjects with Abnormal Liver Function Test (LFT) - An Open Labeled, Multicenter, Non-Comparative, Interventional, Prospective Clinical Study

Background: Test drug is a polyherbal formulation developed by S ava Healthcare Ltd, for the management of various liver disorders. Aim: The main aim was to evaluate efficacy and safety of Test drug in liver disorder subjects with abnormal liver function test (LFT). Materials and Methods: An open labeled, multicenter, non-comparative, interventional, prospective clinical study was conducted. Subjects were advised to consume 2 tablets of Test drug twice daily orally after meals with water for 2 months or till complete normalization of LFT whichever was earlier. The efficacy endpointswere change in AST, ALT, serum total bilirubin, adverse events, vital parameters and safety laboratory parameters. Efficacy endpoints were analyzed using student paired t test. P values were reported based on two-sided tests and interpreted at 5 % level of significance. Results: 53 subjects completed the study. Test drug was safe and significantly effective in normalizing elevated liver enzymes. Normalization of elevated liver enzymes happened in 15 days in few subjects. At the end of the treatment, liver functions were within normal limits in all the subjects. Test drug was also effective in reducing inflammation and fatty liver changes as observed in USG findings. Mild to moderate adverse events reported which were not related to the study drug. No significant change in any of the safety laboratory parameters and vitals was observed. Conclusion: Test drug is safe and effective medicine for the treatment of Liver Disorder Patients with Abnormal Liver Function Test.