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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

NCT01680003 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2013-04-12

No results posted yet for this study

Summary

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

Conditions

  • Non-alcoholic Fatty Liver Disease

Interventions

DRUG

Hepar-P

DRUG

Placebo for Hepar-P

Sponsors & Collaborators

  • Nova Laboratories Sdn Bhd

    lead INDUSTRY

Principal Investigators

  • Muhammad Radzi Abu Hassan, Dr · Sultanah Bahiyah Hospital, Alor Star

  • Tan Soek Siam, Dr · Selayang Hospital, Selangor

  • Tee Hoi Poh, Dr · Tengku Ampuau Afzan Hospital, Kuantan

  • Rosaida Mohd Said, Dr · Ampang Hospital, Selangor

  • Shashi Kumar Bhaskaran, Dr · Kuala Lumpur Hospital

  • Jayaram Menon, Dr · Queen Elizaberth Hospital, Sabah

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-09-30
Primary Completion
2013-10-31
Completion
2013-12-31

Countries

  • Malaysia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01680003 on ClinicalTrials.gov