Clinical trial NCT06127225: Proliverenol Supplementation for Non-Alcoholic Fatty Liver Disease (NAFLD)
Official title: The Effect of Proliverenol Supplementation on Liver Function in Patients With Non-Alcoholic Fatty Liver Disease (NAFLD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-Alcoholic Fatty Liver Disease (NAFLD)
Keywords: NAFLD
Proliverenol
Lead sponsor: Dexa Medica Group
Sponsor class: INDUSTRY
Collaborators: name: PT Equilab International
First posted: 2023-11-13
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Changes of serum ALT levels
timeFrame: 4, 8, and 12 weeks
measure: Changes of serum AST levels
timeFrame: 4, 8, and 12 weeks
Secondary outcomes:
measure: USG examination for Controlled Attenuated Parameter (CAP)
timeFrame: 0 and 12 weeks
measure: USG examination for Transient elastography (TE)
timeFrame: 0 and 12 weeks
measure: Ratio of Aspartate transaminase (AST) to alanine transaminase (ALT) serum levels
timeFrame: 4, 8, and 12 weeks
measure: Liver function (GGT and AP)
timeFrame: 0 and 12 weeks
measure: Liver function (Bilirubin)
timeFrame: 0 and 12 weeks
measure: Lipid profile (Total cholesterol, LDL, HDL, triglyceride)
timeFrame: 0 and 12 weeks
measure: Renal function (Ureum and creatinine)
timeFrame: 0 and 12 weeks
measure: Hematology test
timeFrame: 0 and 12 weeks
measure: Adverse events
timeFrame: 4, 8, and 12 weeks
Other outcomes:
Locations:
city: Jakarta Pusat
country: Indonesia
facility: Division of Hepatology, Dr. Cipto Mangunkusumo Hospital
state: Jakarta
Study officials:
affiliation: Division of Hepatology, Departement of Internal Medicine Faculty of Medicine, University of Indonesia Dr. Cipto Mangunkusumo Hospital
name: Irsan D. Hasan, MD, SpPD, KGEH
role: PRINCIPAL_INVESTIGATOR
References: