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Completed

NCT Number: NCT06127225

Proliverenol Supplementation for Non-Alcoholic Fatty Liver Disease (NAFLD)

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Division of Hepatology, Dr. Cipto Mangunkusumo Hospital

Jakarta Pusat, Jakarta Special Capital Region, 10430, Indonesia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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

Treatment and study plan

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

Placebo caplets of Proliverenol

Drug

2 caplets of Proliverenol Placebo daily

Primary outcomes

  1. Changes of serum ALT levels

    Time frame: 4, 8, and 12 weeks

    Changes of serum ALT levels from baseline to Week 4, 8, and 12 of study treatment

  2. Changes of serum AST levels

    Time frame: 4, 8, and 12 weeks

    Changes of serum AST levels from baseline to Week 4, 8, and 12 of study treatment

Secondary outcomes

  1. USG examination for Controlled Attenuated Parameter (CAP)

    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

  2. USG examination for Transient elastography (TE)

    Time frame: 0 and 12 weeks

    USG examination for Transient elastography (TE) measurement will be performed on baseline and week 12 of study treatment

  3. Ratio of Aspartate transaminase (AST) to alanine transaminase (ALT) serum levels

    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

  4. Liver function (GGT and AP)

    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

  5. Liver function (Bilirubin)

    Time frame: 0 and 12 weeks

    Concentration of total bilirubin at Baseline and at the End of study

  6. Lipid profile (Total cholesterol, LDL, HDL, triglyceride)

    Time frame: 0 and 12 weeks

    Concentration of total cholesterol, LDL, HDL, triglyceride at Baseline and at the End of study

  7. Renal function (Ureum and creatinine)

    Time frame: 0 and 12 weeks

    Level of ureum and creatinine at Baseline and at the End of study

  8. Hematology test

    Time frame: 0 and 12 weeks

    Hematology test (especially leucocyte and platelet counts) at Baseline and at the End of study

  9. Adverse events

    Time frame: 4, 8, and 12 weeks

    Adverse event, will be observed throughout the study conduct

Sponsors and collaborators

Lead sponsor

Dexa Medica Group

Industry

Collaborators

  • PT Equilab International

Registry information

Official study title

The Effect of Proliverenol Supplementation on Liver Function in Patients With Non-Alcoholic Fatty Liver Disease (NAFLD)

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Nov 13, 2023
Registry last updated
Feb 6, 2025

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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