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
Phenomen Pharma
90 participants
Jun 19, 2025
INTERVENTIONAL
Conditions
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
Eligibility
Inclusion Criteria8
- 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 Criteria7
- 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)
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Interventions
Dietary supplement "Gepaktiv" 60 minutes before meals 2 capsules × 3 times/day
UDCA 10-15 mg/kg/day
Ademetionine 800-1600 mg/day.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07068191