Hepar-P Study to Evaluate the Safety and Efficacy of a Standardised Extract of Phyllanthus Niruri for the Treatment of Non-alcoholic Fatty Liver Disease

Study Overview
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Brief Summary
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This is a multi-center, double blind, parallel group placebo controlled randomised trial designed to determine the safety and efficacy of a Standardised Extract of Phyllanthus Niruri (EPN 797) HEPAR-P capsule for the treatment of Non-alcoholic Fatty Liver Disease for a treatment period of 48 weeks

Official Title
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A Multi-Centre, Randomised, Double-Blind, Placebo-Controlled Trial to Determine the Efficacy and Safety of HEPAR-P Capsule for the Treatment of Non-alcoholic Fatty Liver Disease (NAFLD)

Conditions
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Non-alcoholic Fatty Liver Disease

Intervention / Treatment
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* Drug: Hepar-P
* Drug: Placebo for Hepar-P


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or non-pregnant females age 18 years or older Written informed consent obtained from patient or parents/ guardian Elevated serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels but less than 2.5times the upper limit of the normal range Patients with liver biopsy confirmed possible or definite steatohepatitis within the past 12 months prior to enrolment into the trial Possible steatohepatitis with activity score ≥3 OR definite steatohepatitis with activity score ≥5 A score of at least 1 for hepatocellular ballooning Exclusion Criteria: Pregnant or nursing woman or women of childbearing potential except if post-menopausal, surgically sterile or using accepted method(s) of birth control or having negative pregnancy test Participation in any trial in which the patient received an investigational product within 30 days preceding the screening phase of this study Those persons directly involved in the conduct of the study Alcohol consumption of more than 20g per day for women or more than 30g per day for men for at least 3 consecutive months during the previous 5 years, as assessed with the use of the Lifetime Drinking History questionnaire and the interview version of the Alcohol Use and Disorders Identification Test (AUDIT) History of cirrhosis, hepatitis C or other liver diseases History of heart failure (New York Association Class II to IV) History of taking medications known to cause steatohepatitis Any serious medical conditions or disability, which in the opinion of the investigator, would interfere with treatment or assessment or preclude completion of this study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hepar-P<br>Hepar-P: Two capsules (250mg x 2), three times daily, orally | Drug: Hepar-P<br> <br> |
| Placebo Comparator: Placebo for Hepar-P<br>Placebo: Two capsules, three times daily, orally | Drug: Placebo for Hepar-P<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in serum aspartate aminotransferase and alanine aminotransferase levels |  | 48 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Histologic findings including degree of steatosis, lobular inflammation, hepatocellular ballooning and fibrosis and overall disease activity score |  | 48 weeks |