Ignite Creation Date:
2025-12-25 @ 4:16 AM
Ignite Modification Date:
2026-02-27 @ 7:05 PM
Study NCT ID:
NCT01872520
Status:
COMPLETED
Last Update Posted:
2015-10-27
First Post:
2013-04-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Post-marketing Safety Surveillance of the Injection of DanShenDuoFenSuanYan A Real World Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D064420', 'term': 'Drug-Related Side Effects and Adverse Reactions'}], 'ancestors': [{'id': 'D064419', 'term': 'Chemically-Induced Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30180}, 'targetDuration': '2 Weeks', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-10-26', 'studyFirstSubmitDate': '2013-04-13', 'studyFirstSubmitQcDate': '2013-06-05', 'lastUpdatePostDateStruct': {'date': '2015-10-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-06-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The incidence of IDSDFSY induced adverse drug reaction', 'timeFrame': '3 years'}, {'measure': 'The rare adverse drug reactions to the IDSDFSY', 'timeFrame': '3 years'}], 'secondaryOutcomes': [{'measure': 'The manifestation, treatment and outcomes of the ADRs', 'timeFrame': '3 years', 'description': 'To describe manifestation, treatment and outcomes of the ADRs.'}, {'measure': 'The risk factors of the ADRs', 'timeFrame': '3 years', 'description': 'To examine the risk factors of the ADRs.'}, {'measure': "The patients' characteristics who are prescribed IDSDFSY", 'timeFrame': '3 years', 'description': "To describe the patients' characteristics who are prescribed IDSDFSY."}, {'measure': 'The prescribing pattern of IDSDFSY in real world clinical practice', 'timeFrame': '3 years', 'description': 'To characterize the prescribing pattern of IDSDFSY in real world clinical practice.'}, {'measure': 'Off-label use of IDSDFSY', 'timeFrame': '3 years', 'description': 'To describe and evaluate the off-label use of IDSDFSY.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['the Injection of DanShenDuoFenSuanYan', 'Magnesium Lithospermate B', 'Safety', 'Real World Study'], 'conditions': ['Adverse Drug Reaction']}, 'referencesModule': {'references': [{'pmid': '28125608', 'type': 'DERIVED', 'citation': 'Yan YY, Yang YH, Wang WW, Pan YT, Zhan SY, Sun MY, Zhang H, Zhai SD. Post-Marketing Safety Surveillance of the Salvia Miltiorrhiza Depside Salt for Infusion: A Real World Study. PLoS One. 2017 Jan 26;12(1):e0170182. doi: 10.1371/journal.pone.0170182. eCollection 2017.'}]}, 'descriptionModule': {'briefSummary': 'Magnesium Lithospermate B, the main constituent of the Injection of DanShenDuoFenSuanYan (the Injection of Depsides Salts From Salvia Miltiorrhiza), is the active ingredient of Salvia Miltiorrhiza. This study record clinical use of The injection of DanShenDuoFenSuanYan in the real world, and observe the adverse drug reactions/ adverse drug events during treatment.', 'detailedDescription': 'As a traditional chinese medicine, the Injection of DanShenDuoFenSuanYan (the Injection of Depsides Salts From Salvia Miltiorrhiza) was approved by State Food and Drug Administration of China in May,2005. This cardiovascular drug is one of the few Traditional Chinese Medicine pharmaceuticals where the active ingredients have been identified in the molecular levels. In its 8 years marketing in China, there is no serious adverse drug reactions.\n\nIn this study, clinical pharmacists in selected hospitals will record the clinical use and the adverse drug reactions/ adverse drug events of this injection.\n\nThis real world study for the Injection of DanShenDuoFenSuanYan with 30400 patients will be conducted from June.2012 to May.2014.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who use the Injection of DanShenDuoFenSuanYan in 30 hospitals in china(including the inpatient and the outpatient(only in some hospitals which can get the information))', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who use the Injection of DanShenDuoFenSuanYan in 30 hospitals in china(including the inpatient and the outpatient(only in some hospitals which can get the information)).\n\nExclusion Criteria:\n\n* none'}, 'identificationModule': {'nctId': 'NCT01872520', 'briefTitle': 'Post-marketing Safety Surveillance of the Injection of DanShenDuoFenSuanYan A Real World Study', 'organization': {'class': 'OTHER', 'fullName': 'Peking University Third Hospital'}, 'officialTitle': 'Post-marketing Safety Surveillance of the Injection of DanShenDuoFenSuanYan (the Injection of Depsides Salts From Salvia Miltiorrhiza): A Real World Study', 'orgStudyIdInfo': {'id': 'PekingUTH-Pharmacy-001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'the Injection of DanShenDuoFenSuanYan', 'description': 'Patient who use the Injection of DanShenDuoFenSuanYan'}]}, 'contactsLocationsModule': {'locations': [{'zip': '233004', 'city': 'Bengbu', 'state': 'Anhui', 'country': 'China', 'facility': 'The First Affiliated Hospital of Bengbu Medical College', 'geoPoint': {'lat': 32.94083, 'lon': 117.36083}}, {'zip': '100053', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': "Guang'anmen Hospital affiliatied to China Academy of Chinese Medical Sciences", 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100191', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Peking university third hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100700', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'The Military General Hospital of Beijing PLA', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100853', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': "The General Hospital of People's Liberation Army(301 hospital)", 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '66000', 'city': 'Qinhuangdao', 'state': 'Hebei', 'country': 'China', 'facility': 'First Hospital Of Qinhuangdao', 'geoPoint': {'lat': 39.94104, 'lon': 119.58936}}, {'zip': '050000', 'city': 'Shijiazhuang', 'state': 'Hebei', 'country': 'China', 'facility': 'The Second Hospital of Hebei Medical University', 'geoPoint': {'lat': 38.04139, 'lon': 114.47861}}, {'zip': '50051', 'city': 'Shijiazhuang', 'state': 'Hebei', 'country': 'China', 'facility': 'Hebei General Hospital', 'geoPoint': {'lat': 38.04139, 'lon': 114.47861}}, {'zip': '430014', 'city': 'Wuhan', 'state': 'Hubei', 'country': 'China', 'facility': 'Wuhan Hospital of Traditional Chinese Medicine', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'zip': '430022', 'city': 'Wuhan', 'state': 'Hubei', 'country': 'China', 'facility': 'Wuhan Asia Heart Hospital', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'zip': '430022', 'city': 'Wuhan', 'state': 'Hubei', 'country': 'China', 'facility': 'Wuhan Integrated TCM and Western Medicine Hospital', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'zip': '430061', 'city': 'Wuhan', 'state': 'Hubei', 'country': 'China', 'facility': 'Hubei Provincial Hospital of TCM', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'zip': '215600', 'city': 'Zhangjiagang', 'state': 'Jiangsu', 'country': 'China', 'facility': 'Zhangjiagang Hospital Of Traditional Chinese Medicine', 'geoPoint': {'lat': 31.865, 'lon': 120.53889}}, {'city': 'Weinan', 'state': 'Shaanxi', 'country': 'China', 'facility': 'Weinan Central Hospital', 'geoPoint': {'lat': 34.50355, 'lon': 109.50891}}, {'zip': '710000', 'city': "Xi'an", 'state': 'Shaanxi', 'country': 'China', 'facility': 'Tangdu Hospital', 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}, {'zip': '710000', 'city': "Xi'an", 'state': 'Shaanxi', 'country': 'China', 'facility': 'Xijing hospital', 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}, {'zip': '710003', 'city': "Xi'an", 'state': 'Shaanxi', 'country': 'China', 'facility': 'Shaanxi Province Hospital of Traditional Chinese Medicine', 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}, {'zip': '710068', 'city': "Xi'an", 'state': 'Shaanxi', 'country': 'China', 'facility': "Shaanxi Provincial People's Hospital", 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}, {'zip': '716000', 'city': 'Yan’an', 'state': 'Shaanxi', 'country': 'China', 'facility': 'Yanan University Affiliated Hospital', 'geoPoint': {'lat': 36.59889, 'lon': 109.49167}}, {'zip': '200002', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Shanghai Huangpu District Central Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '200021', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Shuguang Hospital Shanghai University of Traditional Chinese Medicine', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '200031', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Huashan Hospital Fudan University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '200032', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Longhua Hospital Shanghai University of TCM', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '201100', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Minhang District Central Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '201700', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Central Hospital Of Qingpu District, Shanghai', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '610031', 'city': 'Chengdu', 'state': 'Sichuan', 'country': 'China', 'facility': 'Sichuan 2nd Hospital Of TCM', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}, {'zip': '610041', 'city': 'Chengdu', 'state': 'Sichuan', 'country': 'China', 'facility': "Hospital Of Chengdu Office Of People's Government of Tibetan Autonomous Region (Hospital.C.T.)", 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}, {'zip': '610081', 'city': 'Chengdu', 'state': 'Sichuan', 'country': 'China', 'facility': 'Affiliated Hospital of Chengdu University', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}, {'city': 'Chengdu', 'state': 'Sichuan', 'country': 'China', 'facility': 'AVIC 363 Hospital', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}, {'zip': '646200', 'city': 'Hejiang', 'state': 'Sichuan', 'country': 'China', 'facility': 'China S.C.H.J. Hospital Of TCM', 'geoPoint': {'lat': 28.81161, 'lon': 105.83359}}, {'zip': '832008', 'city': 'Shihezi', 'state': 'Xinjiang', 'country': 'China', 'facility': 'The First Affiliated Hospital of the Medical College, Shihezi University', 'geoPoint': {'lat': 44.3023, 'lon': 86.03694}}, {'zip': '830000', 'city': 'Ürümqi', 'state': 'Xinjiang', 'country': 'China', 'facility': 'The Fifth Affiliated Hospital of Xinjiang Medical University', 'geoPoint': {'lat': 43.80096, 'lon': 87.60046}}, {'zip': '830000', 'city': 'Ürümqi', 'state': 'Xinjiang', 'country': 'China', 'facility': 'Traditional Chinese Medicine Hospital of Xinjiang Uygur Autonomous Region', 'geoPoint': {'lat': 43.80096, 'lon': 87.60046}}, {'zip': '830001', 'city': 'Ürümqi', 'state': 'Xinjiang', 'country': 'China', 'facility': "People's Hospital of Xinjiang Uygur Autonomous Region", 'geoPoint': {'lat': 43.80096, 'lon': 87.60046}}, {'zip': '830049', 'city': 'Ürümqi', 'state': 'Xinjiang', 'country': 'China', 'facility': 'Chest Hospital of Xinjiang Uygur Autonomous Region', 'geoPoint': {'lat': 43.80096, 'lon': 87.60046}}, {'zip': '830054', 'city': 'Ürümqi', 'state': 'Xinjiang', 'country': 'China', 'facility': 'The First Affiliated Hospital of Xinjiang Medical University', 'geoPoint': {'lat': 43.80096, 'lon': 87.60046}}], 'overallOfficials': [{'name': 'Suodi ZHAI, B.S.', 'role': 'STUDY_CHAIR', 'affiliation': 'Peking University Third Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking University Third Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Shanghai Greenvalley Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}, {'name': 'Peking University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Suodi ZHAI, Department of Pharmacy, Peking University Third Hospital', 'investigatorFullName': 'Suodi ZHAI', 'investigatorAffiliation': 'Peking University Third Hospital'}}}}