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Compares treatment options for Metabolic Dysfunction-associated Fatty Liver Disease (MAFLD)
Official title Gepaktiv vs UDCA and Ademetionine in MAFLD With Hepatomegaly
ClinicalTrials.gov ID: NCT07068191
What this study is testing
What is Dietary supplement "Gepaktiv"?
Dietary supplement "Gepaktiv" is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for metabolic dysfunction-associated fatty liver disease (mafld).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- 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)
You likely can't join if
- 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)
See the full eligibility 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
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Tyumen, Tyumen Oblast, Russia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tyumen, Tyumen Oblast, Russia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.