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

Status: Recruiting
Location: See location...
Intervention Type: Combination product, Drug
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Russian Federation
Tyumen State Medical University
RECRUITING
Tyumen
Contact Information
Primary
Evgeniy Chesnokov, MD, Professor
e.v.chesnokov@mail.ru
+79091846111
Time Frame
Start Date: 2025-06-19
Estimated Completion Date: 2025-08
Participants
Target number of participants: 90
Treatments
Active_comparator: Group 2 (n=30)
Group 2 (n=30): UDCA 10-15 mg/kg/day;
Active_comparator: Group 3 (n=30)
Group 3 (n=30): Ademetionine 800-1600 mg/day.
Experimental: Group 1 (n=30)
Participants receive dietary supplement 'Gepaktiv' (2 capsules × 3 times/day, 60 minutes before meals
Sponsors
Leads: Phenomen Pharma

This content was sourced from clinicaltrials.gov

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