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Gepaktiv vs UDCA and Ademetionine in MAFLD With Hepatomegaly
Sponsor: Phenomen Pharma
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
Official title: 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
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
90
Start Date
2025-06-19
Completion Date
2025-08
Last Updated
2025-07-23
Healthy Volunteers
No
Conditions
Interventions
Dietary supplement "Gepaktiv"
Dietary supplement "Gepaktiv" 60 minutes before meals 2 capsules × 3 times/day
UDCA (Ursodeoxycholic acid)
UDCA 10-15 mg/kg/day
Ademetionine
Ademetionine 800-1600 mg/day.
Locations (1)
Tyumen State Medical University
Tyumen, Tyumen Oblast, Russia