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Gepaktiv vs UDCA and Ademetionine in MAFLD With Hepatomegaly

NCT07068191 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2025-07-23

No results posted yet for this study

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

Conditions

  • 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

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.

Sponsors & Collaborators

  • Phenomen Pharma

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-19
Primary Completion
2025-07-31
Completion
2025-08-31

Countries

  • Russia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07068191 on ClinicalTrials.gov