Ignite Creation Date:
2025-12-24 @ 9:21 PM
Ignite Modification Date:
2026-01-21 @ 2:36 PM
Study NCT ID:
NCT01764204
Status:
COMPLETED
Last Update Posted:
2018-02-19
First Post:
2013-01-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hospital Intensive Monitoring of Adverse Drug Reactions of Qingkailing Injection In The Next Two Years
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C504928', 'term': 'Qingkailing'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'whole blood of the patient with severe adverse drug reactions'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30840}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2018-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-02-15', 'studyFirstSubmitDate': '2013-01-07', 'studyFirstSubmitQcDate': '2013-01-07', 'lastUpdatePostDateStruct': {'date': '2018-02-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-01-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'incidence of severe adverse drug reactions', 'timeFrame': '2 years'}], 'secondaryOutcomes': [{'measure': 'incidence of adverse drug reactions', 'timeFrame': '2 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Adverse Drug Events', 'Adverse Drug Reactions']}, 'referencesModule': {'references': [{'pmid': '39513382', 'type': 'DERIVED', 'citation': 'Yao Q, Wei T, Qiu H, Cai Y, Yuan L, Liu X, Li X. Epigenetic Effects of Natural Products in Inflammatory Diseases: Recent Findings. Phytother Res. 2025 Jan;39(1):90-137. doi: 10.1002/ptr.8364. Epub 2024 Nov 8.'}]}, 'descriptionModule': {'briefSummary': 'To highlight the incidence of adverse reactions of Qingkailing Injection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '1 Year', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'all the patients treated by Qingkailing Injection in the certain centers(hospitals) in the next 2 years.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* all the patients treated by Qingkailing Injection in the certain centers(hospitals) in the next 2 years.\n* in accordance with ethics requirements.\n\nExclusion Criteria:\n\n* none.'}, 'identificationModule': {'nctId': 'NCT01764204', 'briefTitle': 'Hospital Intensive Monitoring of Adverse Drug Reactions of Qingkailing Injection In The Next Two Years', 'organization': {'class': 'OTHER', 'fullName': 'China Academy of Chinese Medical Sciences'}, 'officialTitle': 'Intensive Hospital-based Adverse Drug Reaction Monitoring Study On Patients Treated By Qingkailing Injection In The Next Two Years', 'orgStudyIdInfo': {'id': 'Qingkailing-V5.0'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Qingkailing Injection', 'interventionNames': ['Drug: Qingkailing Injection']}], 'interventions': [{'name': 'Qingkailing Injection', 'type': 'DRUG', 'otherNames': ['Shineway Qingkailing Injection'], 'description': 'Qingkailing Injection is a kind of natural product injection made from Chinese herbs, which has been used to treat cerebral ischemia for decades in China. The main bioactive ingredients of this injection include Baicalin, Jasminoidin, Ursodeoxycholic Acid, Concha Margaritifera,etc.', 'armGroupLabels': ['Qingkailing Injection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100094', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': "National Defense University Hospital of People's Liberation Army", 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '518000', 'city': 'Shenzhen', 'state': 'Guangdong', 'country': 'China', 'facility': "Ren'ai Hospital", 'geoPoint': {'lat': 22.54554, 'lon': 114.0683}}, {'zip': '526600', 'city': 'Zhaoqing', 'state': 'Guangdong', 'country': 'China', 'facility': 'Chinese Medicine Hospital of Deqing County', 'geoPoint': {'lat': 23.04893, 'lon': 112.46091}}, {'zip': '071599', 'city': 'Baoding', 'state': 'Hebei', 'country': 'China', 'facility': 'Chinese Medicine Hospital of Gaoyang County', 'geoPoint': {'lat': 38.87288, 'lon': 115.46246}}, {'zip': '071599', 'city': 'Baoding', 'state': 'Hebei', 'country': 'China', 'facility': 'Gaoyang County Hospital', 'geoPoint': {'lat': 38.87288, 'lon': 115.46246}}, {'zip': '071802', 'city': 'Baoding', 'state': 'Hebei', 'country': 'China', 'facility': "The Third People's Hospital of Xiong County", 'geoPoint': {'lat': 38.87288, 'lon': 115.46246}}, {'zip': '071899', 'city': 'Baoding', 'state': 'Hebei', 'country': 'China', 'facility': 'Chinese Medicine Hospital of Xiong County', 'geoPoint': {'lat': 38.87288, 'lon': 115.46246}}, {'zip': '072350', 'city': 'Baoding', 'state': 'Hebei', 'country': 'China', 'facility': 'Chinese Medicine Hospital of Tang County', 'geoPoint': {'lat': 38.87288, 'lon': 115.46246}}, {'zip': '072350', 'city': 'Baoding', 'state': 'Hebei', 'country': 'China', 'facility': "People's Hospital of Tang County", 'geoPoint': {'lat': 38.87288, 'lon': 115.46246}}, {'zip': '056001', 'city': 'Handan', 'state': 'Hebei', 'country': 'China', 'facility': 'Chinese Medicine Hospital of Handan City', 'geoPoint': {'lat': 36.60999, 'lon': 114.48764}}, {'zip': '057150', 'city': 'Handan', 'state': 'Hebei', 'country': 'China', 'facility': 'The First Hospital of Yongnian District', 'geoPoint': {'lat': 36.60999, 'lon': 114.48764}}, {'zip': '057150', 'city': 'Handan', 'state': 'Hebei', 'country': 'China', 'facility': 'The Second Hospital of Yongnian District', 'geoPoint': {'lat': 36.60999, 'lon': 114.48764}}, {'zip': '050011', 'city': 'Shijiazhuang', 'state': 'Hebei', 'country': 'China', 'facility': 'Central Hospital of Shijiazhuang City', 'geoPoint': {'lat': 38.04139, 'lon': 114.47861}}, {'zip': '050041', 'city': 'Shijiazhuang', 'state': 'Hebei', 'country': 'China', 'facility': 'Hebei Chest Hospital', 'geoPoint': {'lat': 38.04139, 'lon': 114.47861}}, {'zip': '050061', 'city': 'Shijiazhuang', 'state': 'Hebei', 'country': 'China', 'facility': 'Chinese Medicine Hospital of Shijiazhuang City', 'geoPoint': {'lat': 38.04139, 'lon': 114.47861}}, {'zip': '054000', 'city': 'Xingtai', 'state': 'Hebei', 'country': 'China', 'facility': 'Central Hospital of Qinghe County', 'geoPoint': {'lat': 37.06217, 'lon': 114.49272}}, {'zip': '054001', 'city': 'Xingtai', 'state': 'Hebei', 'country': 'China', 'facility': 'Chinese Medicine Hospital of Xingtai City', 'geoPoint': {'lat': 37.06217, 'lon': 114.49272}}, {'zip': '054001', 'city': 'Xingtai', 'state': 'Hebei', 'country': 'China', 'facility': 'Eye Hospital of Xingtai City', 'geoPoint': {'lat': 37.06217, 'lon': 114.49272}}, {'zip': '054099', 'city': 'Xingtai', 'state': 'Hebei', 'country': 'China', 'facility': 'The Second Affiliated Hospital of Xingtai Medical College', 'geoPoint': {'lat': 37.06217, 'lon': 114.49272}}, {'zip': '054800', 'city': 'Xingtai', 'state': 'Hebei', 'country': 'China', 'facility': 'Chinese Medicine Hospital of Qinghe County', 'geoPoint': {'lat': 37.06217, 'lon': 114.49272}}, {'zip': '151801', 'city': 'Harbin', 'state': 'Heilongjiang', 'country': 'China', 'facility': 'The Second Hospital of Bayan County', 'geoPoint': {'lat': 45.75, 'lon': 126.65}}, {'zip': '462099', 'city': 'Luohe', 'state': 'Henan', 'country': 'China', 'facility': 'Luohe Hospital of Chinese Medicine', 'geoPoint': {'lat': 33.56394, 'lon': 114.04272}}, {'zip': '472000', 'city': 'Sanmenxia', 'state': 'Henan', 'country': 'China', 'facility': 'Central Hospital of Sanmenxia City', 'geoPoint': {'lat': 34.78081, 'lon': 111.19287}}, {'zip': '472100', 'city': 'Sanmenxia', 'state': 'Henan', 'country': 'China', 'facility': "People's Hospital of Shan County", 'geoPoint': {'lat': 34.78081, 'lon': 111.19287}}, {'zip': '472500', 'city': 'Sanmenxia', 'state': 'Henan', 'country': 'China', 'facility': "The First People's Hospital of Lingbao", 'geoPoint': {'lat': 34.78081, 'lon': 111.19287}}, {'zip': '453003', 'city': 'Xinxiang', 'state': 'Henan', 'country': 'China', 'facility': 'Chinese Medicine Hospital of Xinxiang City', 'geoPoint': {'lat': 35.19033, 'lon': 113.80151}}, {'zip': '453003', 'city': 'Xinxiang', 'state': 'Henan', 'country': 'China', 'facility': 'The Third Affiliated Hospital of Xinxiang Medical University', 'geoPoint': {'lat': 35.19033, 'lon': 113.80151}}, {'zip': '453200', 'city': 'Xinxiang', 'state': 'Henan', 'country': 'China', 'facility': "People's Hospital of Yanjin County", 'geoPoint': {'lat': 35.19033, 'lon': 113.80151}}, {'zip': '453300', 'city': 'Xinxiang', 'state': 'Henan', 'country': 'China', 'facility': 'Chinese Medicine Hospital of Fengqiu County', 'geoPoint': {'lat': 35.19033, 'lon': 113.80151}}, {'zip': '453399', 'city': 'Xinxiang', 'state': 'Henan', 'country': 'China', 'facility': "People's Hospital of Fengqiu County", 'geoPoint': {'lat': 35.19033, 'lon': 113.80151}}, {'zip': '453500', 'city': 'Xinxiang', 'state': 'Henan', 'country': 'China', 'facility': "People's Hospital of Yuanyang County", 'geoPoint': {'lat': 35.19033, 'lon': 113.80151}}, {'zip': '451100', 'city': 'Xinzheng', 'state': 'Henan', 'country': 'China', 'facility': "People's Hospital of Xinzheng City", 'geoPoint': {'lat': 34.3966, 'lon': 113.74162}}, {'zip': '450008', 'city': 'Zhengzhou', 'state': 'Henan', 'country': 'China', 'facility': 'Third Affiliated Hospital of Henan College of Traditional Chinese Medicine', 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}, {'zip': '451199', 'city': 'Zhengzhou', 'state': 'Henan', 'country': 'China', 'facility': 'Chinese Medicine Hospital of Xinzheng', 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}, {'zip': '116001', 'city': 'Dalian', 'state': 'Liaoning', 'country': 'China', 'facility': 'Affiliated Zhongshan Hospital of Dalian University', 'geoPoint': {'lat': 38.91222, 'lon': 121.60222}}, {'zip': '252001', 'city': 'Liaocheng', 'state': 'Shandong', 'country': 'China', 'facility': 'Central Hospital of Liaocheng City', 'geoPoint': {'lat': 36.45064, 'lon': 116.00247}}, {'zip': '252003', 'city': 'Liaocheng', 'state': 'Shandong', 'country': 'China', 'facility': "Veterans'Hospital", 'geoPoint': {'lat': 36.45064, 'lon': 116.00247}}, {'zip': '252027', 'city': 'Liaocheng', 'state': 'Shandong', 'country': 'China', 'facility': 'Chinese Medicine Hospital of Dongchangfu District', 'geoPoint': {'lat': 36.45064, 'lon': 116.00247}}, {'zip': '252100', 'city': 'Liaocheng', 'state': 'Shandong', 'country': 'China', 'facility': 'Chinese Medicine Hospital of Chiping County', 'geoPoint': {'lat': 36.45064, 'lon': 116.00247}}, {'zip': '252300', 'city': 'Liaocheng', 'state': 'Shandong', 'country': 'China', 'facility': "YangGuXian People's Hospital", 'geoPoint': {'lat': 36.45064, 'lon': 116.00247}}, {'zip': '252661', 'city': 'Liaocheng', 'state': 'Shandong', 'country': 'China', 'facility': 'Chinese Medicine Hospital of Linqing', 'geoPoint': {'lat': 36.45064, 'lon': 116.00247}}, {'zip': '252800', 'city': 'Liaocheng', 'state': 'Shandong', 'country': 'China', 'facility': 'Chinese Medicine Hospital of Gaotang County', 'geoPoint': {'lat': 36.45064, 'lon': 116.00247}}, {'city': 'Weinan', 'state': 'Shanxi', 'country': 'China', 'facility': 'Community Health Center of Duqiao'}, {'zip': '713800', 'city': 'Xianyang', 'state': 'Shanxi', 'country': 'China', 'facility': 'Chinese Medicine Hospital of Sanyuan County'}, {'zip': '655500', 'city': 'Qujing', 'state': 'Yunnan', 'country': 'China', 'facility': "People's Hospital of Fuyuan County", 'geoPoint': {'lat': 25.48333, 'lon': 103.78333}}, {'zip': '655600', 'city': 'Qujing', 'state': 'Yunnan', 'country': 'China', 'facility': 'Chinese Medicine Hospital of Luliang County', 'geoPoint': {'lat': 25.48333, 'lon': 103.78333}}, {'zip': '655600', 'city': 'Qujing', 'state': 'Yunnan', 'country': 'China', 'facility': "People's Hospital of Luliang County", 'geoPoint': {'lat': 25.48333, 'lon': 103.78333}}, {'zip': '655700', 'city': 'Qujing', 'state': 'Yunnan', 'country': 'China', 'facility': 'Chinse Medical Hospital of Shizong County', 'geoPoint': {'lat': 25.48333, 'lon': 103.78333}}], 'overallOfficials': [{'name': 'Zhong Wang, Ph.D., M.D.', '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': 'Professor', 'investigatorFullName': 'Zhong Wang', 'investigatorAffiliation': 'China Academy of Chinese Medical Sciences'}}}}