Ignite Creation Date:
2025-12-24 @ 3:06 PM
Ignite Modification Date:
2026-01-02 @ 5:00 PM
Study NCT ID:
NCT01612559
Status:
UNKNOWN
Last Update Posted:
2012-06-06
First Post:
2012-06-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety Study of Kudiezi (a Chinese Medicine Injection) Used in Hospitals in China
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2016-08-01', '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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30000}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-06', 'completionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-06-03', 'studyFirstSubmitDate': '2012-06-03', 'studyFirstSubmitQcDate': '2012-06-03', '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 Kudiezi'ADRs and identify factors that contributed to the occurrence of the adverse reaction", 'timeFrame': "to assess Kudiezi's 'adverse event' and 'drug adverse reaction' during patients' hospital stay, administration information of Kudiezi will be registered every day. The registry procedure will last 3 years only for patients using Kudiezi.", 'description': "All patients will be measured and assessed at the time Kudiezi is administered to them until they discharge. Patients using Kudiezi will be registered on a registration form including disease background, Kudiezi'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 Kudiezi."}]}, '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 October 2011.\n\nIt was funded by China major scientific and technological specialized project for 'significant new formulation of new drugs'.\n\nKudiezi 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\nSafety surveillance on Chinese Medicine injection is an important problem that needs to be sorted out through large sample observational study.\n\nA registry study for Kudiezi injection safety surveillance with 30000 patients will be conducted from Jan.2012 to Dec.2015.\n\nEligibility criteria Patients who will use Kudiezi injection in selected hospitals\n\nData will be collected in four aspects by four different forms as following:\n\nForm A (blue): demographic information Form B (yellow): adverse drug events/reaction Form C (white): extracted information from hospital information system and laboratory information system Form D (red): personalized information'}, '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 Kudiezi injection from 2012 to 2014 in more than 20 hospitals.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients using Kudiezi injection from 2012 to 2014\n\nExclusion Criteria:\n\n* none'}, 'identificationModule': {'nctId': 'NCT01612559', 'acronym': 'RSCMI-Ⅱ', 'briefTitle': 'Safety Study of Kudiezi (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 Kudiezi (a Chinese Medicine Injection) Used in China', 'orgStudyIdInfo': {'id': 'RSCMI-Ⅱ'}, 'secondaryIdInfos': [{'id': 'RSCMI-Ⅱ', 'type': 'REGISTRY', 'domain': 'Registry study on Chinese Medicine Injection'}]}, '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'}, 'collaborators': [{'name': 'Dongfang Hospital Beijing University of Chinese Medicine', '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': '2016-08-01', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Yanming Xie, Deputy Director, China Academy of Chinese Medical Sciences'}}}}