Ignite Creation Date:
2025-12-25 @ 2:53 AM
Ignite Modification Date:
2025-12-26 @ 1:34 AM
Study NCT ID:
NCT01612533
Status:
UNKNOWN
Last Update Posted:
2012-06-06
First Post:
2012-06-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety Study of Shenfu (a Chinese Medicine Injection) Used in Hospitals in China
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'releaseDate': '2016-07-26', 'unreleaseDateUnknown': True}, {'resetDate': '2016-09-16', 'releaseDate': '2016-07-29'}], 'estimatedResultsFirstSubmitDate': '2016-07-26'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D012769', 'term': 'Shock'}, {'id': 'D003327', 'term': 'Coronary Disease'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20000}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-06', 'completionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-06-05', 'studyFirstSubmitDate': '2012-06-03', 'studyFirstSubmitQcDate': '2012-06-05', 'lastUpdatePostDateStruct': {'date': '2012-06-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-06-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Number of participants with adverse events; incidence of Shenfu'ADRs and identify factors that contributed to the occurrence of the adverse reaction.", 'timeFrame': 'The registry procedure will last 3 years only for patients using Shenfu.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Shock', 'Coronary Heart Disease']}, 'descriptionModule': {'briefSummary': "This study was advocated by Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences in October 2011.\n\nIt was funded by China major scientific and technological specialized project for 'significant new formulation of new drugs'.\n\nShenfu is kind of Chinese Medicine injection used for treating shock and coronary heart disease in many Chinese hospitals.\n\nThe purpose of this study is to determine adverse drug events or adverse drug reaction in large sample size 20,000 patients.", 'detailedDescription': 'Safety surveillance on Chinese Medicine injection is an important problem that needs to be sorted out ,because in mainland China hospitals ,Chinese Medicine Injection are used widely. Population for taking medicine characteristics,the incidence rate of ADR and other uncertain factors influence can not be found now.\n\nA registry study for Shenfu injection safety surveillance with 20000 patients will be conducted from Jan.2012 to Dec.2015.\n\nEligibility criteria Patients who will use Shenfu 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 20000. Patients using Shenmai injection from 2012 to 2014 in 15 hospitals.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients using Shenfu injection from 2012 to 2014'}, 'identificationModule': {'nctId': 'NCT01612533', 'briefTitle': 'Safety Study of Shenfu (a Chinese Medicine Injection) Used in Hospitals in China', 'organization': {'class': 'OTHER', 'fullName': 'China Academy of Chinese Medical Sciences'}, 'officialTitle': 'A Registry Study on Safety Surveillance of Shenfu (a Chinese Medicine Injection) Used in China', 'orgStudyIdInfo': {'id': 'RSCMI-IV'}}, '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': '2016-07-26', 'type': 'RELEASE'}, {'type': 'UNRELEASE', 'dateUnknown': True}, {'date': '2016-07-29', 'type': 'RELEASE'}, {'date': '2016-09-16', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Yanming Xie, Deputy Director, China Academy of Chinese Medical Sciences'}}}}