NCT06127225CompletedPhase 2
Proliverenol Supplementation for Non-Alcoholic Fatty Liver Disease (NAFLD)
The Effect of Proliverenol Supplementation on Liver Function in Patients With Non-Alcoholic Fatty Liver Disease (NAFLD)
Source: ClinicalTrials.gov · Last updated 6 Feb 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 80 (actual)
- First submitted
- 7 Nov 2023
- Start date
- 28 Apr 2023
- Primary completion date
- 9 Aug 2024
- Lead sponsor
- Dexa Medica Group
- Diseases
- Fatty liver disease (MASLD/MASH)
- NCT number
- NCT06127225
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 80
- From 28 Apr 2023 to the primary completion date, 9 Aug 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- Suspected positive COVID-19 based on clinical symptoms or SARS-COV-2 antigen test
- Suspected alcoholic liver disease
- History of or presence of autoimmune liver diseases
- History or presence of significant/advanced CV, metabolic, acute or chronic infectious diseases, including viral hepatitis (B and C), or malignancy.
- Known or suspected hypersensitivity to the trial product or related products
Lab values
- Presence of Bilirubin level \> 2x ULN
- Uncontrolled Diabetes Mellitus with HbA1c ≥ 9.0%
- Suspected cirrhosis as supported by biochemical profile (PLT count, albumin)
Other
- Pregnancy and lactation period.
- Presence of severe renal dysfunction
- Current or regular use of herbal medicines with hepato-protective properties
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Division of Hepatology, Dr. Cipto Mangunkusumo Hospital Coordinator of this site? Confirm its status | Jakarta Pusat | Indonesia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.