Non-alcoholic Fatty Liver Disease | 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
Non-alcoholic Fatty Liver Disease research study
What is the primary objective of this study?
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
Who is eligible to participate?
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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Non-alcoholic Fatty Liver Disease
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:Placebo for Hepar-P
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Hepar-PHepar-P: Two capsules (250mg x 2), three times daily, orally
Placebo for Hepar-PPlacebo: Two capsules, three times daily, orally
Start Date: September 2012
Completed Date: December 2013
Phase: Phase 2
Primary Outcome: Improvement in serum aspartate aminotransferase and alanine aminotransferase levels
Secondary Outcome: Histologic findings including degree of steatosis, lobular inflammation, hepatocellular ballooning and fibrosis and overall disease activity score
Study sponsors, principal investigator, and references
Principal Investigator: Muhammad Radzi Abu Hassan, Dr
Lead Sponsor: Nova Laboratories Sdn Bhd