Gepaktiv vs UDCA and Ademetionine in MAFLD With Hepatomegaly
Recruiting · NCT07068191 · Interventional (participants receive a specific treatment) · Lead sponsor: Phenomen Pharma
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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
Who can take part
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)
Where it is running
1 location listed.
- Tyumen State Medical University - Tyumen, Tyumen Oblast, Russia