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

Non-Alcoholic Fatty Liver Disease (NAFLD) Clinical Trial

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

Status Recruiting

Clinical Trial 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. Pre-clinical study of Proliverenol showed that it exerted the hepatoprotective activity through increasing cell survival via: 1) up-regulation of DNA repair enzyme; 2) down-regulation of NF-kB, TNFα and caspase-8 expressions, to prevent ALT leakage in HepG2 cells. Proliverenol repressed ALT expression, which could also be significantly important as possible alternative mechanism for increased blood transaminase activities. Caspase-8 pathway seemed to be involved in the molecular pathway rather than directly inducing mitochondrial damage. Taken together, ethanol induced apoptosis through NF-kB-TNFα-caspase-8 pathway, and Proliverenol protected the cells from the toxicity conditions.

Clinical Trial 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 I : 2 caplets of Placebo daily The eligible subjects will be randomly allocated to receive study medication (Treatment 1 or Treatment 2) for 12 weeks of treatment, in a double blind fashion. They 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. ;

Related Conditions & MeSH terms

• Fatty Liver
• Liver Diseases
• Non-alcoholic Fatty Liver Disease
• Non-Alcoholic Fatty Liver Disease (NAFLD)

• NCT number: NCT06127225
• Study type: Interventional
• Source: Dexa Medica Group
• Contact: Irsan Hasan, MD, SpPD, KGEH
• Phone: +628161616306
• Email: irsan_h@yahoo.com
• Status: Recruiting
• Phase: Phase 2
• Start date: April 28, 2023
• Completion date: February 28, 2024