Gepaktiv vs UDCA and Ademetionine in MAFLD With Hepatomegaly

This randomized, open-label, parallel-group study evaluates the hepatoprotective effects of the dietary supplement Gepaktiv (250 mg capsules) compared to ursodeoxycholic acid (UDCA) and ademetionine in 90 patients with metabolic-associated fatty liver disease (MAFLD) and hepatomegaly. Study Design: * Duration: 15-day treatment with optional 60-day follow-up * 3 treatment arms (n=30 each): 1. Gepaktiv (2 capsules × 3 times daily) 2. UDCA (10-15 mg/kg/day) 3. Ademetionine (800-1600 mg/day) * Randomization: 1:1:1 block randomization Primary Endpoints: 1. ≥30% reduction in ALT levels 2. Liver size reduction (ultrasound) 3. Improvement in FibroScan parameters (CAP for steatosis, kPa for fibrosis) Secondary Endpoints: * Changes in other liver enzymes (AST, GGT, bilirubin) * Lipid profile (triglycerides, cholesterol) * Albumin and total protein levels * Quality of life assessment (CLDQ questionnaire) Methodology Highlights: * Standardized ultrasound protocol (single operator) * Central laboratory analysis of biomarkers * All efficacy-related assessments (FibroScan, ultrasound, and laboratory blood tests) are performed by blinded evaluators who are not involved in patient management or aware of group assignment * Daily compliance monitoring through patient diaries