- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05343780
Clinical Trial to Investigate the Anti-oxidant Activity of Heptex in Patients With Apparent Risk Factors of NASH (PHYLLANTEX)
April 18, 2022 updated by: Natural Wellness Egypt
A Phase II, Randomized, Double Blind, Placebo-Controlled Clinical Trial to Investigate the Anti-oxidant Activity of Heptex in Patients With Apparent Risk Factors of Nonalcoholic Steatohepatitis (NASH)
A Phase II, Randomized, Double Blind, Placebo-Controlled Clinical Trial to Investigate the Anti-oxidant Activity of Heptex in Patients with Apparent Risk Factors of Nonalcoholic Steatohepatitis (NASH)
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This is a phase II, randomized, double blind placebo-controlled, three-arm, parallel-group, intervention clinical trial evaluating anti-oxidant activity of Heptex; a herbal medicinal product of Aerial Parts of Phyllanthus niruri (Dukung Anak) and Fruits of Silybum marianum (Milk Thistle) in patients with apparent risk factors of NASH.
Study Type
Interventional
Enrollment (Actual)
142
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Cairo, Egypt
- National Hepatology & Tropical Medicine Research Instistute
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Cairo, Egypt
- Tropical Medicine Department, Faculty of Medicine, Ain Shams University
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Male or female aged between 18 and 65 years.
- Both male and female patients who have childbearing potential must agree to practice an acceptable method of birth control during the study and for at least 6 months after the cessation of treatment; such contraceptive methods must include at least one barrier method.
- Controlled Attenuation Parameter (CAP)-confirmed hepatic steatosis.
- Patients with elevated serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels but less than 2.5 times the upper limit of the normal range.
- Liver fibrosis stage F1-F2 as diagnosed by the FibroScan liver stiffness measurement of 5-10 kPa.
Liver condition according the following criteria;
- Serum albumin > 3 g/dl
- INR < 2
- No ascites on ultrasound
- No documented or suspected hepatic encephalopathy
- Willing to stop any other liver support and hepatoprotective medications throughout study duration.
- Able and willing to provide written informed consent.
- Able and willing to complete all study visits and procedures, including compliance with the requirements and restrictions listed in the consentform.
Exclusion Criteria:
- Pregnant or lactating women.
- Patients with BMI > 40 Kg/m2 or BMI < 18.5 Kg/m2.
- Serum creatinine > 1.5 x ULN OR creatinine clearance (GFR) < 60 mL/minute.
- Platelet count < 75,000/mm3.
- Uncontrolled diabetes mellitus as evident by HbA1c ≥ 8.5%.
- Patients who are currently receiving Thiazolidinediones.
- Patients with ischemic heart disease (IHD).
- History of parenteral nutrition.
- History of liver transplant.
- Viral hepatitis, drug-induced liver injury, metabolic liver disease or auto-immune liver disease.
- Liver cancer or serum alpha-fetoprotein (AFP) >100ng/ml. Patients with an AFP between 50 and 100ng/ml may be included as long as a liver ultrasound within 3 months of screening, or at screening, shows no evidence of potential hepatocellular cancer.
- Use of drugs known to induce steatosis (valproate, amiodarone or prednisone) or to affect body weight and carbohydrate metabolism.
- Use of drugs known to alter liver enzymes.
- Allergy or allergic history to any of the drug components.
- History of alcohol abuse as assessed by the investigator within the past 2 years, or an alcohol use pattern that may interfere with the patient's study compliance. Patients must have abstained from alcohol for at least 6 months prior to study start.
- Patients with history of clinically-significant illness or any other major medical disorder that may interfere with subject treatment, assessment, or compliance with the protocol.
- Receipt of an investigational drug within 6 months prior to screening, or active enrolment in another investigational medication or device trial.
- Patients with any chronic illness or prior treatment which in the opinion of the investigator should preclude participation in the trial.
- Inability to understand and cooperate with the investigators or to give valid consent.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
Placebo (Rice bran) in 2 capsules size 1, administered PO TID on empty stomach with plenty of water.
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Placebo
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Experimental: Heptex-low dose
Low dose The contents of one capsule of Heptex is equally distributed and inserted into 2 capsules size 1, administered PO TID on empty stomach with plenty of water.
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Dukung Anak 200 mg + Milk thistle 100 mg
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Experimental: Heptex-high dose
High dose The contents of two capsule of Heptex is equally distributed and inserted into 2 capsules size 1, administered PO TID on empty stomach with plenty of water.
|
Dukung Anak 200 mg + Milk thistle 100 mg
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
explore the anti-oxidant activity of Heptex
Time Frame: 36 weeks
|
assessed by the change in serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels in patients with apparent risk factors of NASH.
|
36 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
explore the hepatoprotective effect of Heptex
Time Frame: 36 weeks
|
assessed by the change in Fibrosis score (F0 to F1: 2 to 7 kPa, F2: 7.5 to 10 kPa, F3: 10 to 14 kPa, F4: 14 kPa or higher) and by the occurrence of hepatic complications.
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36 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To explore the lipid-lowering effect of Heptex
Time Frame: 36 weeks
|
To explore the lipid-lowering effect of Heptex as assessed by the change in lipid profile.
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36 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 8, 2019
Primary Completion (Actual)
February 21, 2022
Study Completion (Actual)
February 21, 2022
Study Registration Dates
First Submitted
May 15, 2019
First Submitted That Met QC Criteria
April 18, 2022
First Posted (Actual)
April 25, 2022
Study Record Updates
Last Update Posted (Actual)
April 25, 2022
Last Update Submitted That Met QC Criteria
April 18, 2022
Last Verified
April 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NW_PHYLLANTEX_17052018
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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