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

• Status: Recruiting
• Trial end date: 2024-02-28
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dexa Medica Group
• Collaborator: PT Equilab International

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