Gepaktiv vs UDCA and Ademetionine in MAFLD With Hepatomegaly
NCT ID: NCT07068191
Last Updated: 2025-07-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
90 participants
INTERVENTIONAL
2025-06-19
2025-08-31
Brief Summary
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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
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Detailed Description
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Study Design:
* Duration: 15-day treatment with optional 60-day follow-up
* 3 treatment arms (n=30 each):
1. Gepaktiv (2 capsules × 3 times daily)
2. UDCA (10-15 mg/kg/day)
3. Ademetionine (800-1600 mg/day)
* Randomization: 1:1:1 block randomization
Primary Endpoints:
1. ≥30% reduction in ALT levels
2. Liver size reduction (ultrasound)
3. Improvement in FibroScan parameters (CAP for steatosis, kPa for fibrosis)
Secondary Endpoints:
* Changes in other liver enzymes (AST, GGT, bilirubin)
* Lipid profile (triglycerides, cholesterol)
* Albumin and total protein levels
* Quality of life assessment (CLDQ questionnaire)
Methodology Highlights:
* Standardized ultrasound protocol (single operator)
* Central laboratory analysis of biomarkers
* All efficacy-related assessments (FibroScan, ultrasound, and laboratory blood tests) are performed by blinded evaluators who are not involved in patient management or aware of group assignment
* Daily compliance monitoring through patient diaries
Conditions
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Study Design
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RANDOMIZED
PARALLEL
1. Gepaktiv (dietary supplement, 2 capsules × 3 times/day),
2. UDCA (10-15 mg/kg/day),
3. Ademetionine (800-1600 mg/day). Gepaktiv is a dietary supplement; comparator arms receive standard therapy according to national guidelines.
UDCA and Ademetionine are included as standard-of-care active comparators (not investigational drugs).
Post-treatment follow-up is optional (up to 60 days). Blinded assessors evaluate outcomes.
TREATMENT
SINGLE
Study Groups
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Group 2 (n=30)
Group 2 (n=30): UDCA 10-15 mg/kg/day;
UDCA (Ursodeoxycholic acid)
UDCA 10-15 mg/kg/day
Group 3 (n=30)
Group 3 (n=30): Ademetionine 800-1600 mg/day.
Ademetionine
Ademetionine 800-1600 mg/day.
Group 1 (n=30)
Participants receive dietary supplement 'Gepaktiv' (2 capsules × 3 times/day, 60 minutes before meals
Dietary supplement "Gepaktiv"
Dietary supplement "Gepaktiv" 60 minutes before meals 2 capsules × 3 times/day
Interventions
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Dietary supplement "Gepaktiv"
Dietary supplement "Gepaktiv" 60 minutes before meals 2 capsules × 3 times/day
UDCA (Ursodeoxycholic acid)
UDCA 10-15 mg/kg/day
Ademetionine
Ademetionine 800-1600 mg/day.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
65 Years
ALL
No
Sponsors
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Phenomen Pharma
OTHER
Responsible Party
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Locations
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Tyumen State Medical University
Tyumen, Tyumen Oblast, Russia
Countries
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Central Contacts
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Facility Contacts
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Role: backup
Other Identifiers
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GEP-2025-01
Identifier Type: -
Identifier Source: org_study_id
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