Ignite Creation Date:
2025-12-24 @ 4:07 PM
Ignite Modification Date:
2026-01-25 @ 1:03 PM
Study NCT ID:
NCT01814566
Status:
UNKNOWN
Last Update Posted:
2013-05-14
First Post:
2013-03-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety Study of DanshenDuofensuanyan(a Chinese Medicine Injection)Used in Hospitals in China
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2016-07-29', 'releaseDate': '2016-06-16'}], 'estimatedResultsFirstSubmitDate': '2016-06-16'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D000787', 'term': 'Angina Pectoris'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002637', 'term': 'Chest Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'NONE_RETAINED', 'description': 'Eligibility criteria Patients who will use DanshenDuofensuanyan injection in selected hospitals.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30000}, 'targetDuration': '14 Days', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-03', 'completionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-05-13', 'studyFirstSubmitDate': '2013-03-14', 'studyFirstSubmitQcDate': '2013-03-18', 'lastUpdatePostDateStruct': {'date': '2013-05-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-03-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Number of participants with adverse events; incidence of DanshenDuofensuanyan'adverse drug reaction（ADRs）and identify factors that contributed to the occurrence of the adverse reaction", 'timeFrame': "to assess DanshenDuofensuanyan's 'adverse event' and 'drug adverse reaction' during patients' hospital stay. The registry procedure will last 2 years only for patients using DanshenDuofensuanyan", 'description': "All patients will be measured and assessed at the time DanshenDuofensuanyan is administered to them until they discharge. Patients using DanshenDuofensuanyan will be registered on a registration form including disease background, DanshenDuofensuanyan's administration, and extraction information from hospital information system. An adverse event or drug adverse reaction form also will be used to describe any doubted symptoms or signs from patients. A judgment will be made by doctors directly and a further analysis will be conducted by researchers to decide those potential side effects of DanshenDuofensuanyan."}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Coronary Heart Disease', 'Angina Pectoris']}, 'descriptionModule': {'briefSummary': "This study was advocated by Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences in January 2013.\n\nIt was funded by China major scientific and technological specialized project for 'significant new formulation of new drugs'.\n\nDanshenDuofensuanyan is kind of Chinese Medicine injection used for treating coronary heart disease and angina pectoris in many Chinese hospitals.\n\nThe purpose of this study is to determine adverse drug events or adverse drug reaction in large sample size 30,000 patients.", 'detailedDescription': 'It is very common that Chinese Medicine Injection used in hospitals in mainland China. However safety problems rose in recent years. There could be many uncertain factors influence Chinese Medicine Injection in clinical practice.\n\nIn order to ensure the safety of public drug use and lower drug-induced risks, a registry study for DanshenDuofensuanyan injection safety surveillance with 30000 patients will be conducted from Jan.2013 to Dec.2015.\n\nEligibility criteria Patients who will use DanshenDuofensuanyan injection in selected hospitals.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'An anticipated sample size was caculated in this study, about 30000 Patients using DanshenDuofensuanyan injection from 2013 to 2014 in more than 20 hospitals', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients using DanshenDuofensuanyan injection from 2013 to 2014\n\nExclusion Criteria:\n\n* none'}, 'identificationModule': {'nctId': 'NCT01814566', 'briefTitle': 'Safety Study of DanshenDuofensuanyan(a Chinese Medicine Injection)Used in Hospitals in China', 'organization': {'class': 'OTHER', 'fullName': 'China Academy of Chinese Medical Sciences'}, 'officialTitle': 'Safety Study of DanshenDuofensuanyan(a Chinese Medicine Injection)Used in Hospitals in China', 'orgStudyIdInfo': {'id': '2009ZX09502-030-02'}}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Yan M Xie, BA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'China Academy of Chinese Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Deputy Director', 'investigatorFullName': 'Yanming Xie', 'investigatorAffiliation': 'China Academy of Chinese Medical Sciences'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2016-06-16', 'type': 'RELEASE'}, {'date': '2016-07-29', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Yanming Xie, Deputy Director, China Academy of Chinese Medical Sciences'}}}}