NCT07068191Recruiting
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
Source: ClinicalTrials.gov · Last updated 23 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 90 (estimated)
- First submitted
- 7 Jul 2025
- Start date
- 19 Jun 2025
- Primary completion date
- 31 Jul 2025
- Lead sponsor
- Phenomen Pharma
- Diseases
- Fatty liver disease (MASLD/MASH)
- NCT number
- NCT07068191
What you commit to
- Study type: Interventional
- Planned participants: 90
- From 19 Jun 2025 to the primary completion date, 31 Jul 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Known allergy to any of the study medications or supplement components
Other
- Liver cirrhosis or hepatocellular carcinoma
- Pregnancy or lactation
- Gallstones or biliary obstruction
- Shrunken liver on imaging
- Hepatic cysts (simple liver cysts/biliary cysts)
- Liver nodules (focal liver lesions)
Who the study is looking for
- 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
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Tyumen State Medical University Coordinator of this site? Confirm its status | Tyumen | Russia | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.