Non-Alcoholic Fatty Liver Disease (NAFLD)Phase 2NCT06127225
Proliverenol Supplementation for Non-Alcoholic Fatty Liver Disease (NAFLD)
A Phase 2 study testing Proliverenol in people with Non-Alcoholic Fatty Liver Disease (NAFLD), run by Dexa Medica Group at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Alcoholic Fatty Liver Disease (NAFLD)
- What is being tested?
- Proliverenol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteIndonesia
- Study dates
- 28 Apr 2023to 28 Aug 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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%
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Division of Hepatology, Dr. Cipto Mangunkusumo Hospital
Jakarta Pusat, Jakarta Special Capital Region, 10430
About this study
Official title: The Effect of Proliverenol Supplementation on Liver Function in Patients With 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.
Read the 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.
- Being tested
- Proliverenol, Placebo caplets of Proliverenol
- Keywords
- NAFLD, Proliverenol
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProliverenolDrug
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 ProliverenolDrug
2 caplets of Proliverenol Placebo daily
| Study group | Role | What they receive |
|---|---|---|
| Treatment 1 | Experimental | 1 caplet of Proliverenol 500 mg twice daily Receives: Drug: Proliverenol |
| Treatment 2 | Experimental | 2 caplets of Proliverenol 500 mg once daily Receives: Drug: Proliverenol |
| Treatment 3 | Experimental | 2 caplets of Proliverenol 500 mg twice daily Receives: Drug: Proliverenol |
| Treatment 4 | Placebo comparator | 2 caplets of Placebo daily Receives: Drug: Placebo caplets of Proliverenol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of serum ALT levels
Changes of serum ALT levels from baseline to Week 4, 8, and 12 of study treatment
Measured: 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
Measured: 4, 8, and 12 weeks
Secondary outcomes (9)
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
Measured: 0 and 12 weeks
USG examination for Transient elastography (TE)
USG examination for Transient elastography (TE) measurement will be performed on baseline and week 12 of study treatment
Measured: 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
Measured: 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
Measured: 0 and 12 weeks
Liver function (Bilirubin)
Concentration of total bilirubin at Baseline and at the End of study
Measured: 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
Measured: 0 and 12 weeks
Renal function (Ureum and creatinine)
Level of ureum and creatinine at Baseline and at the End of study
Measured: 0 and 12 weeks
Hematology test
Hematology test (especially leucocyte and platelet counts) at Baseline and at the End of study
Measured: 0 and 12 weeks
Adverse events
Adverse event, will be observed throughout the study conduct
Measured: 4, 8, and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2023
- Study start28 Apr 2023
- Primary completion9 Aug 2024
- Study completion28 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Alcoholic Fatty Liver Disease (NAFLD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dexa Medica Group
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- PT Equilab International
- Responsible party
- Sponsor
- Investigators
- Irsan D. Hasan, MD, SpPD, KGEH, Principal investigator, Division of Hepatology, Departement of Internal Medicine Faculty of Medicine, University of Indonesia Dr. Cipto Mangunkusumo Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06127225
- Sponsor's protocol ID
- CR.079/EQL/2021
- Status last verified
- Feb 2025
- First submitted
- 7 Nov 2023
- Last updated
- 6 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Proliverenol Supplementation on Liver Function in Patients With Non-Alcoholic Fatty Liver Disease (NAFLD)
- ClinicalTrials.gov ID
- NCT06127225
- Acronym / sponsor ID
- CR.079/EQL/2021
- Keywords
- NAFLD, Proliverenol
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Dexa Medica GroupIndustry (pharma, biotech, devices)
- Collaborators
- PT Equilab International
- Study start
- 28 Apr 2023 (actual)
- Primary completion
- 9 Aug 2024 (actual)
- Study completion
- 28 Aug 2024 (actual)
- First posted
- 13 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Treatment 1 | Experimental | Drug: Proliverenol1 caplet of Proliverenol 500 mg twice daily |
| Treatment 2 | Experimental | Drug: Proliverenol2 caplets of Proliverenol 500 mg once daily |
| Treatment 3 | Experimental | Drug: Proliverenol2 caplets of Proliverenol 500 mg twice daily |
| Treatment 4 | Placebo comparator | Drug: Placebo caplets of Proliverenol2 caplets of Placebo daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Proliverenol1 caplet of Proliverenol 500 mg twice daily 2 caplets of Proliverenol 500 mg once daily 2 caplets of Proliverenol 500 mg twice daily | Drug | Treatment 1, Treatment 2, Treatment 3 |
| Placebo caplets of Proliverenol2 caplets of Proliverenol Placebo daily | Drug | Treatment 4 |
Primary outcome
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
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
9 secondary outcomes
USG examination for Controlled Attenuated Parameter (CAP)
Time frame: 0 and 12 weeks
USG examination for Transient elastography (TE)
Time frame: 0 and 12 weeks
Ratio of Aspartate transaminase (AST) to alanine transaminase (ALT) serum levels
Time frame: 4, 8, and 12 weeks
Liver function (GGT and AP)
Time frame: 0 and 12 weeks
Liver function (Bilirubin)
Time frame: 0 and 12 weeks
Lipid profile (Total cholesterol, LDL, HDL, triglyceride)
Time frame: 0 and 12 weeks
Renal function (Ureum and creatinine)
Time frame: 0 and 12 weeks
Hematology test
Time frame: 0 and 12 weeks
Adverse events
Time frame: 4, 8, and 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Irsan D. Hasan, MD, SpPD, KGEH principal investigator
Division of Hepatology, Departement of Internal Medicine Faculty of Medicine, University of Indonesia Dr. Cipto Mangunkusumo Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Proliverenol in people with Non-Alcoholic Fatty Liver Disease (NAFLD), run by Dexa Medica Group at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of serum ALT levels (time frame: 4, 8, and 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2025.