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

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

Inclusion Criteria:

• Age 18 to 65 years
• Confirmed diagnosis of metabolic-associated fatty liver disease (MAFLD)
• Hepatomegaly confirmed by ultrasound (≥3 cm craniocaudal liver enlargement)
• ALT level between 90-150 U/L
• Steatosis ≥260 dB/m by FibroScan (CAP)
• Fibrosis ≥11 kPa by transient elastography (FibroScan)
• Ability to comply with study procedures
• Signed informed consent

Exclusion Criteria:

• Liver cirrhosis or hepatocellular carcinoma
• Pregnancy or lactation
• Known allergy to any of the study medications or supplement components
• Gallstones or biliary obstruction
• Shrunken liver on imaging
• Hepatic cysts (simple liver cysts/biliary cysts)
• Liver nodules (focal liver lesions)

Biochemical and imaging data are evaluated by independent assessors blinded to group assignment. Outcome assessors do not have access to treatment allocation.