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Recruiting NCT07068191

Gepaktiv vs UDCA and Ademetionine in MAFLD With Hepatomegaly

No phase Interventional Metabolic Dysfunction-associated Fatty Liver Disease (MAFLD) Hepatomegaly Nonalcoholic Fatty Liver (NAFL) Nonalcoholic Fatty Liver Disease (NAFLD)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Dietary supplement "Gepaktiv", UDCA (Ursodeoxycholic acid), Ademetionine.
Who it may be relevant to
Registry conditions: Metabolic Dysfunction-associated Fatty Liver Disease (MAFLD), Hepatomegaly, Nonalcoholic Fatty Liver (NAFL), Nonalcoholic Fatty Liver Disease (NAFLD). Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Russia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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 product Dietary supplement "Gepaktiv"
    Dietary supplement "Gepaktiv" 60 minutes before meals 2 capsules × 3 times/day
  • Drug UDCA (Ursodeoxycholic acid)
    UDCA 10-15 mg/kg/day
  • Drug Ademetionine
    Ademetionine 800-1600 mg/day.

Primary outcome measures

  • Reduction in ALT levels by ≥30% from baseline [Time frame: 15 days (+ optional post-observation up to 60 days).]
  • Change in liver size (ultrasound) [Time frame: 15 days (+ optional post-observation up to 60 days).]
  • Improvement in steatosis/fibrosis (FibroScan) [Time frame: 15 days (+ optional post-observation up to 60 days).]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Russia · 1 center
  • Tyumen State Medical University — Tyumen

Identifiers

NCT: NCT07068191 · GEP-2025-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗