RecruitingNot ApplicableNCT07068191

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


Sponsor

Phenomen Pharma

Enrollment

90 participants

Start Date

Jun 19, 2025

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Ademetionine, Dietary supplement "Gepaktiv", and others for people with fatty liver, fatty liver disease, and other related conditions. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

COMBINATION_PRODUCTDietary supplement "Gepaktiv"

Dietary supplement "Gepaktiv" 60 minutes before meals 2 capsules × 3 times/day

DRUGUDCA (Ursodeoxycholic acid)

UDCA 10-15 mg/kg/day

DRUGAdemetionine

Ademetionine 800-1600 mg/day.


Locations(1)

Tyumen State Medical University

Tyumen, Tyumen Oblast, Russia

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NCT07068191


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