Ignite Creation Date:
2025-12-24 @ 7:46 PM
Ignite Modification Date:
2026-02-22 @ 4:29 AM
Study NCT ID:
NCT01680003
Status:
UNKNOWN
Last Update Posted:
2013-04-12
First Post:
2012-09-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
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
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D065626', 'term': 'Non-alcoholic Fatty Liver Disease'}], 'ancestors': [{'id': 'D005234', 'term': 'Fatty Liver'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-04', 'completionDateStruct': {'date': '2013-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-04-10', 'studyFirstSubmitDate': '2012-09-03', 'studyFirstSubmitQcDate': '2012-09-03', 'lastUpdatePostDateStruct': {'date': '2013-04-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-09-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Adverse events reporting, physical examinations and laboratory tests', 'timeFrame': '48 weeks'}], 'primaryOutcomes': [{'measure': 'Improvement in serum aspartate aminotransferase and alanine aminotransferase levels', 'timeFrame': '48 weeks'}], 'secondaryOutcomes': [{'measure': 'Histologic findings including degree of steatosis, lobular inflammation, hepatocellular ballooning and fibrosis and overall disease activity score', 'timeFrame': '48 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Non-alcoholic Fatty Liver Disease']}, 'descriptionModule': {'briefSummary': '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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or non-pregnant females age 18 years or older\n* Written informed consent obtained from patient or parents/ guardian\n* Elevated serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels but less than 2.5times the upper limit of the normal range\n* Patients with liver biopsy confirmed possible or definite steatohepatitis within the past 12 months prior to enrolment into the trial\n* Possible steatohepatitis with activity score ≥3 OR definite steatohepatitis with activity score ≥5\n* A score of at least 1 for hepatocellular ballooning\n\nExclusion Criteria:\n\n* 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\n* Participation in any trial in which the patient received an investigational product within 30 days preceding the screening phase of this study\n* Those persons directly involved in the conduct of the study\n* 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)\n* History of cirrhosis, hepatitis C or other liver diseases\n* History of heart failure (New York Association Class II to IV)\n* History of taking medications known to cause steatohepatitis\n* 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'}, 'identificationModule': {'nctId': 'NCT01680003', 'acronym': 'Hepar-P', 'briefTitle': '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', 'organization': {'class': 'INDUSTRY', 'fullName': 'Nova Laboratories Sdn Bhd'}, 'officialTitle': '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)', 'orgStudyIdInfo': {'id': 'CT11-03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Hepar-P', 'description': 'Hepar-P: Two capsules (250mg x 2), three times daily, orally', 'interventionNames': ['Drug: Hepar-P']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo for Hepar-P', 'description': 'Placebo: Two capsules, three times daily, orally', 'interventionNames': ['Drug: Placebo for Hepar-P']}], 'interventions': [{'name': 'Hepar-P', 'type': 'DRUG', 'armGroupLabels': ['Hepar-P']}, {'name': 'Placebo for Hepar-P', 'type': 'DRUG', 'armGroupLabels': ['Placebo for Hepar-P']}]}, 'contactsLocationsModule': {'locations': [{'zip': '05460', 'city': 'Alor Star', 'state': 'Kedah', 'status': 'RECRUITING', 'country': 'Malaysia', 'contacts': [{'name': 'Muhammad Radzi Abu Hassan, Dr', 'role': 'CONTACT', 'email': 'drradzi91@yahoo.co.uk', 'phone': '+604-7407814'}, {'name': 'Muhammad Radzi Abu Hassan, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Sultamah Bahiyah Hospital', 'geoPoint': {'lat': 6.12104, 'lon': 100.36014}}, {'zip': '50586', 'city': 'Wilayah Persekutuan', 'state': 'Kuala Lumpur', 'status': 'RECRUITING', 'country': 'Malaysia', 'contacts': [{'name': 'Shashi Kumar Kumar Bhaskaran, Dr', 'role': 'CONTACT', 'email': 'dr_shashi@hotmail.com', 'phone': '03-26155555', 'phoneExt': '5691'}, {'name': 'Shashi Kumar Menon Bhaskaran, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Kuala Lumpur Hospital'}, {'zip': '25100', 'city': 'Kuantan', 'state': 'Pahang', 'status': 'RECRUITING', 'country': 'Malaysia', 'contacts': [{'name': 'Tee Hoi Poh, Dr', 'role': 'CONTACT', 'email': 'hptee@hotmail.com', 'phone': '09-5133334'}, {'name': 'Tee Hoi Poh, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Tengku Ampuan Afzan Hospital', 'geoPoint': {'lat': 3.8077, 'lon': 103.326}}, {'zip': '88586', 'city': 'Kota Kinabalu', 'state': 'Sabah', 'status': 'RECRUITING', 'country': 'Malaysia', 'contacts': [{'name': 'Jayaram Menon, Dr', 'role': 'CONTACT', 'email': 'drmjayaram@gmail.com', 'phone': '+(6)088-517555', 'phoneExt': '7117'}, {'name': 'Jayaram Menon, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Queen Elizaberth Hospital', 'geoPoint': {'lat': 5.9749, 'lon': 116.0724}}, {'zip': '68000', 'city': 'Kuala Selangor', 'state': 'Selangor', 'status': 'RECRUITING', 'country': 'Malaysia', 'contacts': [{'name': 'Rosaida Mohd Said, Dr', 'role': 'CONTACT', 'email': 'drrosaida@moh.gov.my', 'phone': '03-42896155'}, {'name': 'Rosaida Mohd Said, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ampang Hospital', 'geoPoint': {'lat': 3.35, 'lon': 101.25}}], 'overallOfficials': [{'name': 'Muhammad Radzi Abu Hassan, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sultanah Bahiyah Hospital, Alor Star'}, {'name': 'Tan Soek Siam, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Selayang Hospital, Selangor'}, {'name': 'Tee Hoi Poh, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tengku Ampuau Afzan Hospital, Kuantan'}, {'name': 'Rosaida Mohd Said, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ampang Hospital, Selangor'}, {'name': 'Shashi Kumar Bhaskaran, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kuala Lumpur Hospital'}, {'name': 'Jayaram Menon, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Queen Elizaberth Hospital, Sabah'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nova Laboratories Sdn Bhd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}