Actively Recruiting
Gepaktiv vs UDCA and Ademetionine in MAFLD With Hepatomegaly
Led by Phenomen Pharma · Updated on 2025-07-23
90
Participants Needed
1
Research Sites
6 weeks
Total Duration
On this page
AI-Summary
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
CONDITIONS
Official Title
Gepaktiv vs UDCA and Ademetionine in MAFLD With Hepatomegaly
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 65 years
- Confirmed diagnosis of metabolic-associated fatty liver disease (MAFLD)
- Liver enlargement (hepatomegaly) confirmed by ultrasound with at least 3 cm craniocaudal increase
- Alanine aminotransferase (ALT) level between 90 and 150 U/L
- Steatosis of at least 260 dB/m measured by FibroScan (CAP)
- Fibrosis measurement of at least 11 kPa by transient elastography (FibroScan)
- Ability to follow study procedures
- Signed informed consent
You will not qualify if you...
- Presence of liver cirrhosis or hepatocellular carcinoma
- Pregnancy or breastfeeding
- Known allergy to any of the study medications or supplement ingredients
- Gallstones or blockage of bile ducts
- Shrunken liver seen on imaging
- Presence of hepatic cysts (simple or biliary cysts)
- Presence of liver nodules or focal liver lesions
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Tyumen State Medical University
Tyumen, Tyumen Oblast, Russia, 625000
Actively Recruiting
Research Team
E
Evgeniy Chesnokov, MD, Professor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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