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

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