About this trial

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 criteria

Qualifiers

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

Disqualifiers

Liver cirrhosis or hepatocellular carcinoma

Pregnancy or lactation

Known allergy to any of the study medications or supplement components

Gallstones or biliary obstruction

Trial design

Treatments tested in this trial

  • Dietary supplement "Gepaktiv"
  • UDCA (Ursodeoxycholic acid)
  • Ademetionine

Treatment groups

90 Participants
are divided into 3 treatment groups

Locations

1
Tyumen State Medical University625000, TyumenTyumen Oblast, Russia

Sponsors and collaborators

Phenomen Pharma

Lead sponsor