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

Nova Laboratories

Status and phase

Unknown

Phase 2

Conditions

Non-alcoholic Fatty Liver Disease

Treatments

Drug: Placebo for Hepar-P

Drug: Hepar-P

Study type

Interventional

Funder types

Industry

Identifiers

NCT01680003

CT11-03

Details and patient eligibility

About

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

Enrollment

50 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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