Ignite Creation Date:
2025-12-25 @ 2:54 AM
Ignite Modification Date:
2026-01-12 @ 1:31 AM
Study NCT ID:
NCT01708733
Status:
COMPLETED
Last Update Posted:
2014-05-29
First Post:
2012-10-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Chinese Herbal Formula (KSY) on HCV Carrier With Abnormal Liver Function
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 57}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-05', 'completionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-05-28', 'studyFirstSubmitDate': '2012-10-15', 'studyFirstSubmitQcDate': '2012-10-15', 'lastUpdatePostDateStruct': {'date': '2014-05-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-10-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'WHOQOL-BREF', 'timeFrame': '6 weeks'}], 'primaryOutcomes': [{'measure': 'HCV RNA titer', 'timeFrame': '6 weeks'}], 'secondaryOutcomes': [{'measure': 'Serum GPT level', 'timeFrame': '6 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['HCV carrier', 'Chinese herbal medicine', 'Liver function', 'HCV RNA titer'], 'conditions': ['Liver Function']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to examine whether the Chinese herbal formula (KSY) is effective on HCV Carrier With Abnormal Liver Function.', 'detailedDescription': 'percentage of change on HCV RNA titer and liver function (GPT).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 40 \\< GPT \\<200 HCV carrier Age: 18-65 yrs old\n\nExclusion Criteria:\n\n* Creatinine \\>2.0 mg/dL Total bilirubin \\> 2.0mg/dL Not suitable patients diagnosis by physician in charge.'}, 'identificationModule': {'nctId': 'NCT01708733', 'briefTitle': 'The Effect of Chinese Herbal Formula (KSY) on HCV Carrier With Abnormal Liver Function', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Taipei City Hospital'}, 'officialTitle': 'An Evaluation of the Extract of KUAN SIN YIN on Hepatitis C: a Randomized, Double-blinded and Placebo-controlled Clinical Trial.', 'orgStudyIdInfo': {'id': '101001-62-010'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'KSY diluted', 'description': 'KSY diluted, 100mg decoction by mouth per day for 6 weeks'}, {'type': 'EXPERIMENTAL', 'label': 'KSY', 'description': 'KSY, 100mg decoction by mouth per day for 6 weeks', 'interventionNames': ['Drug: KSY']}], 'interventions': [{'name': 'KSY', 'type': 'DRUG', 'description': 'Chinese herbal formula', 'armGroupLabels': ['KSY']}]}, 'contactsLocationsModule': {'locations': [{'zip': '886', 'city': 'Taipei', 'state': 'Taiwan', 'country': 'Taiwan', 'facility': 'Taipei City Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Taipei City Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'chief medical officer', 'investigatorFullName': 'Chung-Hua Hsu', 'investigatorAffiliation': 'Taipei City Hospital'}}}}