Gepaktiv compared with standard drugs for fatty liver and enlarged liver
Tests the supplement Gepaktiv against UDCA and ademetionine in adults with fatty liver disease.
Plain-language title generated from the registry record
Registry title: Gepaktiv vs UDCA and Ademetionine in MAFLD With Hepatomegaly
Key facts
- Where
- Tyumen, RussiaSee the site
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 18 to 65 with fatty liver disease (MAFLD) and an enlarged liver. It compares the supplement Gepaktiv with UDCA and Ademetionine.
- Age
- 18 to 65 years
- Sex
- All sexes can join.
- Disease stage
- Confirmed metabolic-associated fatty liver disease (MAFLD). Liver enlarged by at least 3 cm (1.2 in) on ultrasound. ALT between 90-150 U/L. Fat in the liver (steatosis) of at least 260 dB/m and fibrosis of at least 11 kPa on FibroScan.
- Biomarker or test result
- ALT level between 90-150 U/L. FibroScan CAP of at least 260 dB/m. Fibrosis of at least 11 kPa.
Main reasons for not taking part
- Liver cirrhosis or liver cancer (hepatocellular carcinoma)
- Pregnancy or breastfeeding
- Allergy to any study medication or supplement ingredient
- Gallstones or blocked bile ducts
- Shrunken liver, liver cysts or liver nodules on imaging
Read by machine on 12 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT07068191, who can take part
Where in Russia
- Tyumen State Medical UniversityTyumen, RussiaContact: Irina NagibinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Phenomen Pharma
- Trial code
- NCT07068191
- Record updated
- 23 July 2025
- Original description
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).Read full original descriptionShow less
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
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
Inclusion: 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: Known allergy to any of the study medications or supplement components; 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).