Fatty Liver, Fatty Liver, Alcoholic, Fatty Liver Disease, Fatty Liver, Nonalcoholic, Hepatomegaly, Metabolic Dysfunction-associated Fatty Liver Disease (MAFLD), Nonalcoholic Fatty Liver Disease (NAFLD), Nonalcoholic Fatty Liver (NAFL)
Conditions
Keywords
Hepatomegaly, Gepaktiv, Metabolic dysfunction-associated fatty liver disease (MAFLD), metabolic dysfunction-associated steatotic liver disease (MASLD), Nonalcoholic fatty liver disease (NAFLD), liver diseases, Nonalcoholic fatty liver (NAFL), Liver, Liver steatosis, Dietary supplements, Fatty Liver
Brief 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
Detailed description
This randomized, open-label, parallel-group study evaluates the hepatoprotective effects of the dietary supplement Gepaktiv (250 mg capsules) compared to ursodeoxycholic acid (UDCA) and ademetionine in 90 patients with metabolic-associated fatty liver disease (MAFLD) and hepatomegaly. 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
Interventions
COMBINATION_PRODUCTDietary supplement Gepaktiv
Dietary supplement Gepaktiv 60 minutes before meals 2 capsules × 3 times/day
UDCA 10-15 mg/kg/day
DRUGAdemetionine
Ademetionine 800-1600 mg/day.
Sponsors
Phenomen Pharma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Biochemical and imaging data are evaluated by independent assessors blinded to group assignment. Outcome assessors do not have access to treatment allocation.
Intervention model description
Participants are randomly assigned (1:1:1) to three parallel groups for 15 days: 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction in ALT levels by ≥30% from baseline | 15 days (+ optional post-observation up to 60 days). | Proportion of participants achieving ≥30% decrease in serum ALT after 15 days of treatment |
| Change in liver size (ultrasound) | 15 days (+ optional post-observation up to 60 days). | Reduction in liver enlargement (≥1 cm) measured by standardized ultrasound |
| Improvement in steatosis/fibrosis (FibroScan) | 15 days (+ optional post-observation up to 60 days). | Change in CAP (steatosis) and kPa (fibrosis) scores from baseline |
Countries
Russia
Contacts
Primary ContactEvgeniy Chesnokov, MD, Professor
Outcome results
None listed