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
NCT ID: NCT01680003
Last Updated: 2013-04-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
50 participants
INTERVENTIONAL
2012-09-30
2013-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Hepar-P
Hepar-P: Two capsules (250mg x 2), three times daily, orally
Hepar-P
Placebo for Hepar-P
Placebo: Two capsules, three times daily, orally
Placebo for Hepar-P
Interventions
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Hepar-P
Placebo for Hepar-P
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
80 Years
ALL
No
Sponsors
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Nova Laboratories Sdn Bhd
INDUSTRY
Responsible Party
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Principal Investigators
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Muhammad Radzi Abu Hassan, Dr
Role: PRINCIPAL_INVESTIGATOR
Sultanah Bahiyah Hospital, Alor Star
Tan Soek Siam, Dr
Role: PRINCIPAL_INVESTIGATOR
Selayang Hospital, Selangor
Tee Hoi Poh, Dr
Role: PRINCIPAL_INVESTIGATOR
Tengku Ampuau Afzan Hospital, Kuantan
Rosaida Mohd Said, Dr
Role: PRINCIPAL_INVESTIGATOR
Ampang Hospital, Selangor
Shashi Kumar Bhaskaran, Dr
Role: PRINCIPAL_INVESTIGATOR
Kuala Lumpur Hospital
Jayaram Menon, Dr
Role: PRINCIPAL_INVESTIGATOR
Queen Elizaberth Hospital, Sabah
Locations
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Sultamah Bahiyah Hospital
Alor Star, Kedah, Malaysia
Kuala Lumpur Hospital
Wilayah Persekutuan, Kuala Lumpur, Malaysia
Tengku Ampuan Afzan Hospital
Kuantan, Pahang, Malaysia
Queen Elizaberth Hospital
Kota Kinabalu, Sabah, Malaysia
Ampang Hospital
Kuala Selangor, Selangor, Malaysia
Countries
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Facility Contacts
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Other Identifiers
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CT11-03
Identifier Type: -
Identifier Source: org_study_id
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