NCT06127225

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

The Effect of Proliverenol Supplementation on Liver Function in Patients With Non-Alcoholic Fatty Liver Disease (NAFLD)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Dexa Medica Group · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

There will be 4 groups of treatment; each group will consist of 20 subjects with the treatment regimens for 12 weeks: Treatment I : 1 caplet of Proliverenol 500 mg twice daily Treatment II : 2 caplets of Proliverenol 500 mg once daily Treatment III : 2 caplets of Proliverenol 500 mg twice daily Treatment IV : 2 caplets of Placebo daily Study subjects will be asked to come to the clinic every 4-week interval throughout the study period. Subjects will be evaluated for treatment efficacy at baseline and at interval of 4 weeks over the 12-week course of therapy. Throughout the 12-week therapy, subjects should record the product consumption and adverse event occurred during the study in the provided Patient's Diary. The safety profile of study medication other than vital signs and adverse event will be measured at baseline and end of study.

Conditions

• Non-Alcoholic Fatty Liver Disease (NAFLD)

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-04-28
• Primary completion: 2024-08-09
• Completion: 2024-08-28
• First posted: 2023-11-13
• Last updated: 2025-02-06

Locations

1 site across 1 country: Indonesia