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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)

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ClinicalTrials.gov Identifier: NCT01680003
Recruitment Status : Unknown
Verified April 2013 by Nova Laboratories Sdn Bhd.
Recruitment status was:  Recruiting
First Posted : September 6, 2012
Last Update Posted : April 12, 2013
Sponsor:
Information provided by (Responsible Party):
Nova Laboratories Sdn Bhd

Tracking Information
First Submitted Date  ICMJE September 3, 2012
First Posted Date  ICMJE September 6, 2012
Last Update Posted Date April 12, 2013
Study Start Date  ICMJE September 2012
Estimated Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 3, 2012)
Improvement in serum aspartate aminotransferase and alanine aminotransferase levels [ Time Frame: 48 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01680003 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 3, 2012)
Histologic findings including degree of steatosis, lobular inflammation, hepatocellular ballooning and fibrosis and overall disease activity score [ Time Frame: 48 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Outcome Measures  ICMJE
 (submitted: September 3, 2012)
Adverse events reporting, physical examinations and laboratory tests [ Time Frame: 48 weeks ]
Original Other Outcome Measures  ICMJE Same as current
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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)
Brief 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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Non-alcoholic Fatty Liver Disease
Intervention  ICMJE
  • Drug: Hepar-P
  • Drug: Placebo for Hepar-P
Study Arms
  • Experimental: Hepar-P
    Hepar-P: Two capsules (250mg x 2), three times daily, orally
    Intervention: Drug: Hepar-P
  • Placebo Comparator: Placebo for Hepar-P
    Placebo: Two capsules, three times daily, orally
    Intervention: Drug: Placebo for Hepar-P
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: September 3, 2012)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date December 2013
Estimated Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Malaysia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01680003
Other Study ID Numbers  ICMJE CT11-03
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Nova Laboratories Sdn Bhd
Study Sponsor  ICMJE Nova Laboratories Sdn Bhd
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Nova Laboratories Sdn Bhd
Verification Date April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP