Division of Hepatology, Dr. Cipto Mangunkusumo Hospital
Jakarta Pusat, Jakarta Special Capital Region, 10430, Indonesia
NCT Number: NCT06127225
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.
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Notify Me18 year and older
All sexes
Interventional
Phase 2
Jakarta Pusat, Jakarta Special Capital Region, 10430, Indonesia
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
1 caplet of Proliverenol 500 mg twice daily 2 caplets of Proliverenol 500 mg once daily 2 caplets of Proliverenol 500 mg twice daily
2 caplets of Proliverenol Placebo daily
Time frame: 4, 8, and 12 weeks
Changes of serum ALT levels from baseline to Week 4, 8, and 12 of study treatment
Time frame: 4, 8, and 12 weeks
Changes of serum AST levels from baseline to Week 4, 8, and 12 of study treatment
Time frame: 0 and 12 weeks
USG examination for Controlled Attenuated Parameter (CAP) measurement will be performed on baseline and week 12 of study treatment
Time frame: 0 and 12 weeks
USG examination for Transient elastography (TE) measurement will be performed on baseline and week 12 of study treatment
Time frame: 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
Time frame: 0 and 12 weeks
Concentration of serum gamma-glutamyl transpeptidase (GGT) and alkaline phosphatase (AP) at Baseline and at the End of study
Time frame: 0 and 12 weeks
Concentration of total bilirubin at Baseline and at the End of study
Time frame: 0 and 12 weeks
Concentration of total cholesterol, LDL, HDL, triglyceride at Baseline and at the End of study
Time frame: 0 and 12 weeks
Level of ureum and creatinine at Baseline and at the End of study
Time frame: 0 and 12 weeks
Hematology test (especially leucocyte and platelet counts) at Baseline and at the End of study
Time frame: 4, 8, and 12 weeks
Adverse event, will be observed throughout the study conduct
Dexa Medica Group
Industry
The Effect of Proliverenol Supplementation on Liver Function in Patients With Non-Alcoholic Fatty Liver Disease (NAFLD)
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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