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Gepaktiv vs UDCA and Ademetionine in MAFLD With Hepatomegaly

RECRUITINGN/ASponsored by Phenomen Pharma
Actively Recruiting
PhaseN/A
SponsorPhenomen Pharma
Started2025-06-19
Est. completion2025-07
Eligibility
Age18 Years – 65 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT07068191

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

Age: 18 Years – 65 YearsHealthy volunteers accepted
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)

Conditions9

Fatty LiverFatty Liver DiseaseFatty Liver, AlcoholicFatty Liver, NonalcoholicHepatomegalyLiver DiseaseMetabolic Dysfunction-associated Fatty Liver Disease (MAFLD)Nonalcoholic Fatty Liver (NAFL)Nonalcoholic Fatty Liver Disease (NAFLD)

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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