Gepaktiv vs UDCA and Ademetionine in MAFLD With Hepatomegaly (NCT07068191) | Clinical Trial Compass
RecruitingNot Applicable
Gepaktiv vs UDCA and Ademetionine in MAFLD With Hepatomegaly
Russia90 participantsStarted 2025-06-19
Plain-language 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
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Reduction in ALT levels by ≥30% from baseline
Timeframe: 15 days (+ optional post-observation up to 60 days).
2
Change in liver size (ultrasound)
Timeframe: 15 days (+ optional post-observation up to 60 days).
3
Improvement in steatosis/fibrosis (FibroScan)
Timeframe: 15 days (+ optional post-observation up to 60 days).