Ignite Creation Date:
2025-12-24 @ 9:36 PM
Ignite Modification Date:
2026-04-11 @ 3:23 AM
Study NCT ID:
NCT01824732
Status:
UNKNOWN
Last Update Posted:
2013-04-05
First Post:
2013-03-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Registry Study on Tanreqing（a Chinese Medicine Injection）Used in Hospitals in China
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2016-09-16', 'releaseDate': '2016-07-29'}], 'estimatedResultsFirstSubmitDate': '2016-07-29'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D001991', 'term': 'Bronchitis'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 3000}, 'targetDuration': '15 Days', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-04', 'completionDateStruct': {'date': '2013-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-04-02', 'studyFirstSubmitDate': '2013-03-30', 'studyFirstSubmitQcDate': '2013-04-02', 'lastUpdatePostDateStruct': {'date': '2013-04-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-04-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with anaphylactic reaction;the blood of participants with anaphylactic reaction', 'timeFrame': "to assess Tanreqing's 'anaphylactic reaction' .during patients' hospital stay, administration information of Tanreqing will be registered every day. The registry procedure will last 3 month only for patients using Tanreqing"}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Pneumonia;', 'Bronchitis']}, 'descriptionModule': {'briefSummary': 'This study was advocated by Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences in December 2012.\n\nThe purpose of this study is to make a event monitoring to see whether Tanreqing injection is safe and the characteristic and mechanism of anaphylactic reaction used Tanreqing injection in hospitals in China.', '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 Tanreqing injection safety surveillance with 3000 patients will be conducted from Jan.2013 to Mar.2013.At the same time,Patients who have anaphylactic reaction are selected as the allergic group and not have anaphylactic reaction are selected as the control group.The proportion of allergic group and control group is 1:4.All the patients who are selected should draw blood.\n\nEligibility criteria Patients who will use Tanreqing injection in selected hospitals.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '1 Month', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'An anticipated sample size was caculated in this study, about 3000 Patients using Tanreqing injection from January to March 2013 in hospitals.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients using Tanreqing injection from January to March 2013\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT01824732', 'briefTitle': 'A Registry Study on Tanreqing（a Chinese Medicine Injection）Used in Hospitals in China', 'organization': {'class': 'OTHER', 'fullName': 'China Academy of Chinese Medical Sciences'}, 'officialTitle': 'a Study of Clinical Safety Monitoring and the Mechanism of Anaphylactic Reaction Used Tanreqing(a Chinese Medicine Injection)in Hospitals in China', 'orgStudyIdInfo': {'id': '200907001-5-6-2'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Allergic group', 'description': 'All patients who used Tanreqing Injection have anaphylaxis.'}, {'label': 'Control group', 'description': "All patients who used Tanreqing Injection don't have anaphylaxis.One allergic group patient should matched four control group patients."}]}, 'contactsLocationsModule': {'locations': [{'zip': '100700', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Chang Y Peng, Doctor', 'role': 'CONTACT', 'email': 'cyp2668@163.com', 'phone': '010-64014411', 'phoneExt': '2802'}, {'name': 'Xie M Yan, BA', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Institute of Basic Research in Clinical Medicine', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Xie Y Ming, BA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'China Academy of Chinese Medical Sciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'China Academy of Chinese Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director', 'investigatorFullName': 'Yanming Xie', 'investigatorAffiliation': 'China Academy of Chinese Medical Sciences'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2016-07-29', 'type': 'RELEASE'}, {'date': '2016-09-16', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Yanming Xie, Director, China Academy of Chinese Medical Sciences'}}}}