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Randomized Comparative Study of the Effectiveness and Safety of the Dietary Supplement "Gepaktiv" (International name: Phenomenon) versus Ursodeoxycholic Acid (UDCA) and Ademetionine in Patients with MAFLD and Hepatomegaly

Randomized Comparative Study of the Effectiveness and Safety of the Dietary Supplement "Gepaktiv" (International name: Phenomenon) versus Ursodeoxycholic Acid (UDCA) and Ademetionine in Patients with MAFLD and Hepatomegaly

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025001469
Enrollment
Unknown
Registered
2025-07-21
Start date
2025-06-30
Completion date
Unknown
Last updated
2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metabolic dysfunction-associated fatty liver disease (MAFLD) Hepatomegaly

Interventions

Group 1 Gepaktiv:Gepaktiv 250 mg 2 capsules × 3/day 60 minutes before meals
Group 2 UDCA:UDCA (Ursodeoxycholic acid) 10–15 mg/kg/day
Group 3 Ademetionine:Ademetionine 800–1600 mg/day oral

Sponsors

Phenomen pharma
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Age 18–65 years MAFLD confirmed by FibroScan (CAP =260 dB/m kPa =8) Hepatomegaly (=3 cm) Elevated ALT (90–150 U/L)

Exclusion criteria

Exclusion criteria: Cirrhosis cancer HIV Pregnancy/lactation Allergy to ingredients Alcohol abuse <3 months Gallstones liver nodules atrophic liver

Design outcomes

Primary

MeasureTime frame
CAP reduction =10%;•Liver stiffness reduction =10%;?????????? ??????? ?????? =1 ??;ALT reduction =30% ;—

Secondary

MeasureTime frame
Changes in albumin total protein;Adverse events frequency;CLDQ score improvement;—

Countries

Russia

Contacts

Public ContactEvgeniy Chesnokov

Tyumen State Medical University

e.v.chesnokov@mail.ru+79091846111

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026