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Gepaktiv vs UDCA and Ademetionine in MAFLD With Hepatomegaly

Study acronym: HEPACT
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Minor Eligibility criteria shortened, about 4 wordsv3
  2. Minor Eligibility criteria expanded, about 69 wordsv2
  3. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
Trial Details
NCT Number NCT07068191
Lead Sponsor Phenomen Pharma
Conditions
(from sponsor)
Metabolic Dysfunction-associated Fatty Liver Disease (MAFLD), Hepatomegaly, Nonalcoholic Fatty Liver (NAFL), Nonalcoholic Fatty Liver Disease (NAFLD), Fatty Liver, Fatty Liver, Alcoholic, Fatty Liver, Nonalcoholic, Fatty Liver Disease
Related terms Fatty Liver, Fatty Liver, Alcoholic, Hepatomegaly, Liver Diseases, Non-alcoholic Fatty Liver Disease
Enrollment 90 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov