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

NCT ID: NCT06127225

Last Updated: 2025-02-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-28
• Study Completion Date: 2024-08-28

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.

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)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Treatment 1

1 caplet of Proliverenol 500 mg twice daily

Group Type: EXPERIMENTAL

Proliverenol

Intervention Type: 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 2

2 caplets of Proliverenol 500 mg once daily

Group Type: EXPERIMENTAL

Proliverenol

Intervention Type: 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 3

2 caplets of Proliverenol 500 mg twice daily

Group Type: EXPERIMENTAL

Proliverenol

Intervention Type: 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 4

2 caplets of Placebo daily

Group Type: PLACEBO_COMPARATOR

Placebo caplets of Proliverenol

Intervention Type: DRUG

2 caplets of Proliverenol Placebo daily

Interventions

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

Intervention Type: DRUG

Placebo caplets of Proliverenol

2 caplets of Proliverenol Placebo daily

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Signed informed consent

2. Male or female subjects with age of 18 years or older at screening.

3. 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

4. Presence of hepatic impairment, defined as any of serum ALT level > ULN

5. Able to take oral medication.

Exclusion Criteria

1. Suspected positive COVID-19 based on clinical symptoms or SARS-COV-2 antigen test

2. Pregnancy and lactation period.

3. Suspected alcoholic liver disease

4. History of or presence of autoimmune liver diseases

5. Presence of Bilirubin level > 2x ULN

6. Uncontrolled Diabetes Mellitus with HbA1c ≥ 9.0%

7. History or presence of significant/advanced CV, metabolic, acute or chronic infectious diseases, including viral hepatitis (B and C), or malignancy.

8. Suspected cirrhosis as supported by biochemical profile (PLT count, albumin)

9. Presence of severe renal dysfunction

10. 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

11. Current or regular use of herbal medicines with hepato-protective properties

12. Known or suspected hypersensitivity to the trial product or related products

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

PT Equilab International

INDUSTRY

Sponsor Role: collaborator

Dexa Medica Group

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Irsan D. Hasan, MD, SpPD, KGEH

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Division of Hepatology, Dr. Cipto Mangunkusumo Hospital

Jakarta Pusat, Jakarta Special Capital Region, Indonesia

Countries

Indonesia

Other Identifiers

CR.079/EQL/2021

Identifier Type: -

Identifier Source: org_study_id