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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 (Hepar-P)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2013 by Nova Laboratories Sdn Bhd.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01680003
First Posted: September 6, 2012
Last Update Posted: April 12, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Nova Laboratories Sdn Bhd
  Purpose
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

Condition Intervention Phase
Non-alcoholic Fatty Liver Disease Drug: Hepar-P Drug: Placebo for Hepar-P Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:


Further study details as provided by Nova Laboratories Sdn Bhd:

Primary Outcome Measures:
  • Improvement in serum aspartate aminotransferase and alanine aminotransferase levels [ Time Frame: 48 weeks ]

Secondary Outcome Measures:
  • Histologic findings including degree of steatosis, lobular inflammation, hepatocellular ballooning and fibrosis and overall disease activity score [ Time Frame: 48 weeks ]

Other Outcome Measures:
  • Adverse events reporting, physical examinations and laboratory tests [ Time Frame: 48 weeks ]

Estimated Enrollment: 50
Study Start Date: September 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Hepar-P
Hepar-P: Two capsules (250mg x 2), three times daily, orally
Drug: Hepar-P
Placebo Comparator: Placebo for Hepar-P
Placebo: Two capsules, three times daily, orally
Drug: Placebo for Hepar-P

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01680003


Locations
Malaysia
Sultamah Bahiyah Hospital Recruiting
Alor Setar, Kedah, Malaysia, 05460
Contact: Muhammad Radzi Abu Hassan, Dr    +604-7407814    drradzi91@yahoo.co.uk   
Principal Investigator: Muhammad Radzi Abu Hassan, Dr         
Kuala Lumpur Hospital Recruiting
Wilayah Persekutuan, Kuala Lumpur, Malaysia, 50586
Contact: Shashi Kumar Kumar Bhaskaran, Dr    03-26155555 ext 5691    dr_shashi@hotmail.com   
Principal Investigator: Shashi Kumar Menon Bhaskaran, Dr         
Tengku Ampuan Afzan Hospital Recruiting
Kuantan, Pahang, Malaysia, 25100
Contact: Tee Hoi Poh, Dr    09-5133334    hptee@hotmail.com   
Principal Investigator: Tee Hoi Poh, Dr         
Queen Elizaberth Hospital Recruiting
Kota Kinabalu, Sabah, Malaysia, 88586
Contact: Jayaram Menon, Dr    +(6)088-517555 ext 7117    drmjayaram@gmail.com   
Principal Investigator: Jayaram Menon, Dr         
Ampang Hospital Recruiting
Selangor, Malaysia, 68000
Contact: Rosaida Mohd Said, Dr    03-42896155    drrosaida@moh.gov.my   
Principal Investigator: Rosaida Mohd Said, Dr         
Sponsors and Collaborators
Nova Laboratories Sdn Bhd
Investigators
Principal Investigator: Muhammad Radzi Abu Hassan, Dr Sultanah Bahiyah Hospital, Alor Star
Principal Investigator: Tan Soek Siam, Dr Selayang Hospital, Selangor
Principal Investigator: Tee Hoi Poh, Dr Tengku Ampuau Afzan Hospital, Kuantan
Principal Investigator: Rosaida Mohd Said, Dr Ampang Hospital, Selangor
Principal Investigator: Shashi Kumar Bhaskaran, Dr Kuala Lumpur Hospital
Principal Investigator: Jayaram Menon, Dr Queen Elizaberth Hospital, Sabah
  More Information

Responsible Party: Nova Laboratories Sdn Bhd
ClinicalTrials.gov Identifier: NCT01680003     History of Changes
Other Study ID Numbers: CT11-03
First Submitted: September 3, 2012
First Posted: September 6, 2012
Last Update Posted: April 12, 2013
Last Verified: April 2013

Additional relevant MeSH terms:
Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Digestive System Diseases