Status:
COMPLETED
Proliverenol Supplementation for Non-Alcoholic Fatty Liver Disease (NAFLD)
Lead Sponsor:
Dexa Medica Group
Collaborating Sponsors:
PT Equilab International
Conditions:
Non-Alcoholic Fatty Liver Disease (NAFLD)
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 on...
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 caplet...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
April 28 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 28 2024
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT06127225
Start Date
April 28 2023
End Date
August 28 2024
Last Update
February 6 2025
Active Locations (1)
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1
Division of Hepatology, Dr. Cipto Mangunkusumo Hospital
Jakarta Pusat, Jakarta Special Capital Region, Indonesia, 10430