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

NCT06127225 | Completed Phase 2

• 1 other identifier: CR.079/EQL/2021
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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)

Keywords

NAFLD; Proliverenol

Outcome Measures

Primary Outcomes (2)

• Changes of serum ALT levels

  Changes of serum ALT levels from baseline to Week 4, 8, and 12 of study treatment

  4, 8, and 12 weeks

• Changes of serum AST levels

  Changes of serum AST levels from baseline to Week 4, 8, and 12 of study treatment

  4, 8, and 12 weeks

Secondary Outcomes (9)

• USG examination for Controlled Attenuated Parameter (CAP)

  0 and 12 weeks

• USG examination for Transient elastography (TE)

  0 and 12 weeks

• Ratio of Aspartate transaminase (AST) to alanine transaminase (ALT) serum levels

  4, 8, and 12 weeks

• Liver function (GGT and AP)

  0 and 12 weeks

• Liver function (Bilirubin)

  0 and 12 weeks

Study Arms (4)

Treatment 1

EXPERIMENTAL

1 caplet of Proliverenol 500 mg twice daily

Drug: Proliverenol

Treatment 2

EXPERIMENTAL

2 caplets of Proliverenol 500 mg once daily

Drug: Proliverenol

Treatment 3

EXPERIMENTAL

2 caplets of Proliverenol 500 mg twice daily

Drug: Proliverenol

Treatment 4

PLACEBO COMPARATOR

2 caplets of Placebo daily

Drug: Placebo caplets of Proliverenol

Interventions

Proliverenol DRUG

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

Treatment 1; Treatment 2; Treatment 3

Placebo caplets of Proliverenol DRUG

2 caplets of Proliverenol Placebo daily

Treatment 4

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent
• Male or female subjects with age of 18 years or older at screening.
• Diagnosed as NAFLD with liver ultrasonography (USG). Patients with bright liver appearance based on USG, will be followed by CAP examination. Steatosis is defined if CAP \>263 dB/m
• Presence of hepatic impairment, defined as any of serum ALT level \> ULN
• Able to take oral medication.

You may not qualify if:

• Suspected positive COVID-19 based on clinical symptoms or SARS-COV-2 antigen test
• Pregnancy and lactation period.
• Suspected alcoholic liver disease
• History of or presence of autoimmune liver diseases
• Presence of Bilirubin level \> 2x ULN
• Uncontrolled Diabetes Mellitus with HbA1c ≥ 9.0%
• History or presence of significant/advanced CV, metabolic, acute or chronic infectious diseases, including viral hepatitis (B and C), or malignancy.
• Suspected cirrhosis as supported by biochemical profile (PLT count, albumin)
• Presence of severe renal dysfunction
• Current or regular use of drug-induced hepatotoxicity, such as: such as non-steroidal anti-inflammatory drugs (NSAIDs), antibiotics, anti-epileptic drugs (e.g. carbamazepines, phenytoin, barbiturates), or anti-tuberculous drugs other than the investigational product
• Current or regular use of herbal medicines with hepato-protective properties
• Known or suspected hypersensitivity to the trial product or related products

Sponsors & Collaborators

• Dexa Medica Group: lead
• PT Equilab International: collaborator

Study Sites (1)

Division of Hepatology, Dr. Cipto Mangunkusumo Hospital

Jakarta Pusat, Jakarta Special Capital Region, 10430, Indonesia

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Study Officials

• Irsan D. Hasan, MD, SpPD, KGEH

  Division of Hepatology, Departement of Internal Medicine Faculty of Medicine, University of Indonesia Dr. Cipto Mangunkusumo Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2023
• First Posted: November 13, 2023
• Study Start: April 28, 2023
• Primary Completion: August 9, 2024
• Study Completion: August 28, 2024
• Last Updated: February 6, 2025

Record last verified: 2025-02

Locations

ID (1)