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| Name | Class |
|---|---|
| PT Equilab International | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment 1 | Experimental | 1 caplet of Proliverenol 500 mg twice daily |
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| Treatment 2 | Experimental | 2 caplets of Proliverenol 500 mg once daily |
|
| Treatment 3 | Experimental | 2 caplets of Proliverenol 500 mg twice daily |
|
| Treatment 4 | Placebo Comparator | 2 caplets of Placebo daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Proliverenol | Drug | 1 caplet of Proliverenol 500 mg twice daily 2 caplets of Proliverenol 500 mg once daily 2 caplets of Proliverenol 500 mg twice daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes of serum ALT levels | Changes of serum ALT levels from baseline to Week 4, 8, and 12 of study treatment | 4, 8, and 12 weeks |
| Changes of serum AST levels | Changes of serum AST levels from baseline to Week 4, 8, and 12 of study treatment | 4, 8, and 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| USG examination for Controlled Attenuated Parameter (CAP) | USG examination for Controlled Attenuated Parameter (CAP) measurement will be performed on baseline and week 12 of study treatment | 0 and 12 weeks |
| USG examination for Transient elastography (TE) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Irsan D. Hasan, MD, SpPD, KGEH | Division of Hepatology, Departement of Internal Medicine Faculty of Medicine, University of Indonesia Dr. Cipto Mangunkusumo Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Division of Hepatology, Dr. Cipto Mangunkusumo Hospital | Jakarta Pusat | Jakarta Special Capital Region | 10430 | Indonesia |
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| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| Placebo caplets of Proliverenol | Drug | 2 caplets of Proliverenol Placebo daily |
|
USG examination for Transient elastography (TE) measurement will be performed on baseline and week 12 of study treatment |
| 0 and 12 weeks |
| Ratio of Aspartate transaminase (AST) to alanine transaminase (ALT) serum levels | Ratio of Aspartate transaminase (AST) to alanine transaminase (ALT) serum levels at Week 4, 8, and 12 of study treatment | 4, 8, and 12 weeks |
| Liver function (GGT and AP) | Concentration of serum gamma-glutamyl transpeptidase (GGT) and alkaline phosphatase (AP) at Baseline and at the End of study | 0 and 12 weeks |
| Liver function (Bilirubin) | Concentration of total bilirubin at Baseline and at the End of study | 0 and 12 weeks |
| Lipid profile (Total cholesterol, LDL, HDL, triglyceride) | Concentration of total cholesterol, LDL, HDL, triglyceride at Baseline and at the End of study | 0 and 12 weeks |
| Renal function (Ureum and creatinine) | Level of ureum and creatinine at Baseline and at the End of study | 0 and 12 weeks |
| Hematology test | Hematology test (especially leucocyte and platelet counts) at Baseline and at the End of study | 0 and 12 weeks |
| Adverse events | Adverse event, will be observed throughout the study conduct | 4, 8, and 12 weeks |