NCT07068191

Gepaktiv vs UDCA and Ademetionine in MAFLD With Hepatomegaly

Randomized Comparative Clinical Study of the Dietary Supplement "Gepaktiv" (International Name: Phenomenon) in Comparison With Ursodeoxycholic Acid (UDCA) and Ademetionine in Patients With Metabolic Associated Fatty Liver Disease (MAFLD) and Hepatomegaly

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Phenomen Pharma · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This study compares the effectiveness of the dietary supplement Gepaktiv with standard medications (UDCA and Ademetionine) in patients with fatty liver disease (MAFLD) and liver enlargement (hepatomegaly). Key points: * Participants will receive either Gepaktiv, UDCA, or Ademetionine for 15 days * Doctors will monitor liver health through blood tests and ultrasound scans * The study will check if Gepaktiv helps improve liver function as effectively as standard treatments. Main measurements: * Changes in liver enzyme levels (ALT, AST) * Reduction in liver size * Improvement in fat accumulation (steatosis) measured by FibroScan This research may provide evidence for a new natural option to support liver health.Data analysis will be done by an independent biostatistics

Detailed description

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

Conditions

• Metabolic Dysfunction-associated Fatty Liver Disease (MAFLD)
• Hepatomegaly
• Nonalcoholic Fatty Liver (NAFL)
• Nonalcoholic Fatty Liver Disease (NAFLD)
• Fatty Liver
• Fatty Liver, Alcoholic
• Fatty Liver, Nonalcoholic
• Fatty Liver Disease

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Dietary supplement "Gepaktiv"	Dietary supplement "Gepaktiv" 60 minutes before meals 2 capsules × 3 times/day
DRUG	UDCA (Ursodeoxycholic acid)	UDCA 10-15 mg/kg/day
DRUG	Ademetionine	Ademetionine 800-1600 mg/day.

Timeline

• Start date: 2025-06-19
• Primary completion: 2025-07-01
• Completion: 2025-08-01
• First posted: 2025-07-16
• Last updated: 2025-07-23

Locations

1 site across 1 country: Russia