Non-Alcoholic Fatty Liver Disease (NAFLD)
Conditions
Keywords
NAFLD, Proliverenol
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.
Interventions
DRUGProliverenol
1 caplet of Proliverenol 500 mg twice daily 2 caplets of Proliverenol 500 mg once daily 2 caplets of Proliverenol 500 mg twice daily
DRUGPlacebo caplets of Proliverenol
2 caplets of Proliverenol Placebo daily
Sponsors
PT Equilab International
Dexa Medica Group
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes of serum ALT levels | 4, 8, and 12 weeks | Changes of serum ALT levels from baseline to Week 4, 8, and 12 of study treatment |
| Changes of serum AST levels | 4, 8, and 12 weeks | Changes of serum AST levels from baseline to Week 4, 8, and 12 of study treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ratio of Aspartate transaminase (AST) to alanine transaminase (ALT) serum levels | 4, 8, and 12 weeks | Ratio of Aspartate transaminase (AST) to alanine transaminase (ALT) serum levels at Week 4, 8, and 12 of study treatment |
| Liver function (GGT and AP) | 0 and 12 weeks | Concentration of serum gamma-glutamyl transpeptidase (GGT) and alkaline phosphatase (AP) at Baseline and at the End of study |
| Liver function (Bilirubin) | 0 and 12 weeks | Concentration of total bilirubin at Baseline and at the End of study |
| USG examination for Controlled Attenuated Parameter (CAP) | 0 and 12 weeks | USG examination for Controlled Attenuated Parameter (CAP) measurement will be performed on baseline and week 12 of study treatment |
| Renal function (Ureum and creatinine) | 0 and 12 weeks | Level of ureum and creatinine at Baseline and at the End of study |
| Hematology test | 0 and 12 weeks | Hematology test (especially leucocyte and platelet counts) at Baseline and at the End of study |
| Adverse events | 4, 8, and 12 weeks | Adverse event, will be observed throughout the study conduct |
| Lipid profile (Total cholesterol, LDL, HDL, triglyceride) | 0 and 12 weeks | Concentration of total cholesterol, LDL, HDL, triglyceride at Baseline and at the End of study |
| USG examination for Transient elastography (TE) | 0 and 12 weeks | USG examination for Transient elastography (TE) measurement will be performed on baseline and week 12 of study treatment |
Countries
Indonesia
Outcome results
None listed