Status:
COMPLETED
Clinical Trial to Investigate the Anti-oxidant Activity of Heptex in Patients With Apparent Risk Factors of NASH
Lead Sponsor:
Natural Wellness Egypt
Collaborating Sponsors:
Ain Shams University
National Hepatology & Tropical Medicine Research Institute
Conditions:
Nonalcoholic Steatohepatitis
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
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)
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 8 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 21 2022
Estimated Enrollment :
142 Patients enrolled
Trial Details
Trial ID
NCT05343780
Start Date
May 8 2019
End Date
February 21 2022
Last Update
April 25 2022
Active Locations (2)
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1
National Hepatology & Tropical Medicine Research Instistute
Cairo, Egypt
2
Tropical Medicine Department, Faculty of Medicine, Ain Shams University
Cairo, Egypt