Overview
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
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):
- Gepaktiv (2 capsules × 3 times daily)
- UDCA (10-15 mg/kg/day)
- Ademetionine (800-1600 mg/day)
- Randomization: 1:1:1 block randomization
Primary Endpoints:
- ≥30% reduction in ALT levels
- Liver size reduction (ultrasound)
- 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
Eligibility
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)