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Gepaktiv vs UDCA and Ademetionine in MAFLD With Hepatomegaly

ConditionsMetabolic Dysfunction-associated Fatty Liver Disease (MAFLD)HepatomegalyNonalcoholic Fatty Liver (NAFL)Nonalcoholic Fatty Liver Disease (NAFLD)Fatty LiverFatty Liver, AlcoholicFatty Liver, NonalcoholicFatty Liver Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorPhenomen Pharma

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Dietary supplement "Gepaktiv"

    Combination product

    Dietary supplement "Gepaktiv" 60 minutes before meals 2 capsules × 3 times/day

  • UDCA (Ursodeoxycholic acid)

    Drug

    UDCA 10-15 mg/kg/day

  • Ademetionine

    Drug

    Ademetionine 800-1600 mg/day.

Treatment groups

90 Participants
are divided into 3 treatment groups
Group A: Group 2 (n=30)Active comparator 1 intervention
Group B: Group 3 (n=30)Active comparator 1 intervention
Group C: Group 1 (n=30)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Reduction in ALT levels by ≥30% from baseline

Proportion of participants achieving ≥30% decrease in serum ALT after 15 days of treatment

Time frame
15 days (+ optional post-observation up to 60 days).
2

Change in liver size (ultrasound)

Reduction in liver enlargement (≥1 cm) measured by standardized ultrasound

Time frame
15 days (+ optional post-observation up to 60 days).
3

Improvement in steatosis/fibrosis (FibroScan)

Change in CAP (steatosis) and kPa (fibrosis) scores from baseline

Time frame
15 days (+ optional post-observation up to 60 days).

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Phenomen Pharma

Lead sponsor

Source ClinicalTrials.gov
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