Ayush-GMH as an add-on to vitamin E in Grade I and II non-alcoholic fatty liver disease: A study protocol for double-blind randomized placebo-controlled clinical trial

Abstract BACKGROUND: Liver diseases account for 4% of global deaths, with cirrhosis and hepatocellular carcinoma being the leading causes. Non-alcoholic fatty liver disease (NAFLD), characterized by fat accumulation in the liver, is a significant contributor to liver cirrhosis. The prevalence of NAFLD is rising globally, with an estimated prevalence of 37.8% post-2016. In India, NAFLD affects 9% to 32% of the population, particularly those with metabolic disorders like obesity and type 2 diabetes mellitus. Traditional medicines have been widely used in hepatic diseases for centuries in Asia. Ayurveda has a wide array of suitable therapeutic options that can manage it, addressing the various etiopathological factors associated with NAFLD. OBJECTIVE: To evaluate the efficacy and safety of Ayush-GMH, an Ayurvedic formulation, as an add-on to vitamin E in the management of Grade I and II NAFLD. MATERIALS AND METHODS: The study is being conducted as a single-center, prospective, randomized, double-blind, parallel-group, and placebo-controlled clinical trial. Participants of either gender diagnosed with Grade I or II NAFLD on ultrasound scan, aged 18–60 years, will be randomized to receive either Ayush-GMH tablets (500 mg twice daily) or placebo, both alongside vitamin E (400 IU daily) for 180 days. Follow-up assessments will be conducted at 30-day intervals up to 180 days. The primary outcome of the study is to assess the change in the grading of NAFLD using abdominal ultrasonography (USG) at the end of the study. Secondary outcome measures include changes in liver function tests (alanine aminotransferase, aspartate aminotransferase, serum bilirubin, total proteins, and alkaline phosphatase), fatty liver index, and quality of life assessed the RAND SF-36 Health Survey Questionnaire at days 90 and 180 as compared to baseline. CONCLUSION: This study aims to provide evidence for the efficacy and safety of Ayush-GMH as an add-on therapy to vitamin E in managing NAFLD. The findings could offer a preliminary lead for a new integrative treatment approach for the management of NAFLD.