drugset / Trial / NCT07068191

Gepaktiv vs UDCA and Ademetionine in MAFLD With Hepatomegaly

NCT07068191

Recruiting 90 enrolled Phenomen Pharma
RandomizedParallel-groupSingle-blindTreatment

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

Timeline

Start
2025-06-19
Primary completion
2025-07
Completion
2025-08

Drugs

EvaluationDrugModalityDoseRoute
Comparator Ademetionine Unknown 800 mg
Comparator Ademetionine Unknown 1600 mg
Subject Gepaktiv Unknown 250 mg
Comparator Ursodeoxycholic Acid Small molecule 10 mg/kg
Comparator Ursodeoxycholic Acid Small molecule 15 mg/kg