Randomized Comparative Study of Dietary Supplement Gepaktiv Versus Ursodeoxycholic Acid and Ademetionine in Adults With Metabolic-Associated Fatty Liver Disease and Hepatomegaly

What this Trial Is About

Researchers are evaluating the dietary supplement Gepaktiv compared to standard medications ursodeoxycholic acid (UDCA) and ademetionine in adults with metabolic-associated fatty liver disease (MAFLD) and liver enlargement (hepatomegaly). The study aims to determine if Gepaktiv can improve liver function and reduce liver size and fat accumulation as effectively as these established treatments. This is a randomized, open-label study involving 90 patients. Participants will be randomly assigned to one of three groups: Gepaktiv taken as 2 capsules three times daily before meals; UDCA dosed at 10-15 mg/kg/day; or ademetionine at 800-1600 mg/day. The treatment period lasts 15 days, with an optional 60-day follow-up to observe longer-term effects. Doctors will monitor liver health using blood tests, ultrasound scans, and FibroScan to assess liver enzymes, size, and fat or fibrosis levels. During the study, patients will provide daily diaries to track treatment adherence. Evaluations include blood tests for liver enzymes (ALT, AST, GGT, bilirubin), lipid profile, albumin, protein levels, and quality of life questionnaires. Ultrasound and FibroScan will be performed by blinded assessors following standardized protocols. The main outcomes measured are a 30% or greater reduction in ALT, liver size decrease, and improvement in liver fat and fibrosis after 15 days, with additional follow-up assessments if participants continue. The total participation duration may extend up to 75 days including follow-up.

Gepaktiv vs UDCA and Ademetionine in MAFLD With Hepatomegaly