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Proliverenol Supplementation for Non-Alcoholic Fatty Liver Disease (NAFLD)

NCT06127225 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2025-02-06

No results posted yet for this study

Summary

This is a 4-arm, prospective, randomized, double-blind, double-dummy, and placebo-controlled clinical study comparing Proliverenol at a dose of 500 mg twice daily; Proliverenol at a dose of 1000 mg once daily; Proliverenol at a dose of 1000 mg twice daily; and Placebo two caplets daily for a 12-week course of therapy.

Proliverenol is a bioactive fraction derived from the dried fruit of Phaleria macrocarpa (Scheff.) Boerl (Thymelaeaceae). Proliverenol possesses a hepatoprotective activity via anti-inflammation, DNA repairing, and the antiapoptosis properties.

Conditions

  • Non-Alcoholic Fatty Liver Disease (NAFLD)

Interventions

DRUG

Proliverenol

1 caplet of Proliverenol 500 mg twice daily 2 caplets of Proliverenol 500 mg once daily 2 caplets of Proliverenol 500 mg twice daily

DRUG

Placebo caplets of Proliverenol

2 caplets of Proliverenol Placebo daily

Sponsors & Collaborators

  • PT Equilab International

    collaborator INDUSTRY

  • Dexa Medica Group

    lead INDUSTRY

Principal Investigators

  • Irsan D. Hasan, MD, SpPD, KGEH · Division of Hepatology, Departement of Internal Medicine Faculty of Medicine, University of Indonesia Dr. Cipto Mangunkusumo Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-28
Primary Completion
2024-08-09
Completion
2024-08-28

Countries

  • Indonesia

Study Locations

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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 NCT06127225 on ClinicalTrials.gov