Ignite Creation Date:
2025-12-26 @ 1:19 PM
Ignite Modification Date:
2025-12-31 @ 3:58 PM
Study NCT ID:
NCT00351806
Status:
COMPLETED
Last Update Posted:
2013-08-07
First Post:
2006-07-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
AISTCM-Outcome Measurement of Acute Ischemic Stroke With Traditional Chinese Medicine
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002544', 'term': 'Cerebral Infarction'}], 'ancestors': [{'id': 'D020520', 'term': 'Brain Infarction'}, {'id': 'D002545', 'term': 'Brain Ischemia'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020521', 'term': 'Stroke'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 500}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-08', 'completionDateStruct': {'date': '2006-11'}, 'lastUpdateSubmitDate': '2013-08-05', 'studyFirstSubmitDate': '2006-07-12', 'studyFirstSubmitQcDate': '2006-07-12', 'lastUpdatePostDateStruct': {'date': '2013-08-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-07-13', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'death rate, Barthel Index'}], 'secondaryOutcomes': [{'measure': 'Glasgow Outcome Scale (GOS)'}, {'measure': 'Modified Rankin Scale (mRS)'}, {'measure': 'National Institute of Health Stroke Scale (NIHSS)'}, {'measure': 'Stroke Specific Quality of Life (SSQOL)'}, {'measure': 'Scale of Traditional Chinese Medicine (SSTCM)'}]}, 'conditionsModule': {'keywords': ['acute intracerebral infarction'], 'conditions': ['Cerebral Infarction']}, 'referencesModule': {'references': [{'pmid': '20456839', 'type': 'DERIVED', 'citation': 'Huang Y, Guo JW; Project Group for Demonstration Study of Syndrome Differentiation Protocol and Effect Evaluation of Acute Ischemic Stroke. Outcome and safety assessment of an herbal medicine treatment protocol for yin pattern of acute ischemic stroke. Zhong Xi Yi Jie He Xue Bao. 2010 May;8(5):417-26. doi: 10.3736/jcim20100504.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether Traditional Chinese Medicine (TCM) is able to improve the outcome of acute ischemic stroke and to observe its safety.', 'detailedDescription': 'The purpose of this study is to determine whether Traditional Chinese Medicine (TCM) is able to improve the outcome of acute ischemic stroke and safety.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ischemic stroke diagnosis by CT/MRI scan\n* Yin pattern of Traditional Chinese Medicine Theory\n* 40-85 years old\n* Total anterior circulation infarcts (TACI), partial anterior territory cerebral infarction (PACI), lacunar anterior circulation infarcts (LACI) type under Oxfordshire Community Stroke Project (OCSP) standard\n* NIHSS \\>=4;\n* Glasgow coma scale (GCS) \\>=7;\n* Modified Rankin Scale less than 2 degrees before onset of this stroke\n* Informed consent signed by patient or his/her family\n\nExclusion Criteria:\n\n* Hemorrhagic stroke;\n* Coma, GCS\\<=7;\n* Cerebral hernia;\n* Serious heart, liver, lung, kidney functional failure;\n* Gastrointestinal (GI) bleeding;\n* Thrombolysis drugs or surgery was administrated to the patient;\n* Not cooperative with physician;\n* Psychological disorder;\n* Already taken part in other clinical drug trial within the past 3 months'}, 'identificationModule': {'nctId': 'NCT00351806', 'briefTitle': 'AISTCM-Outcome Measurement of Acute Ischemic Stroke With Traditional Chinese Medicine', 'organization': {'class': 'OTHER', 'fullName': 'Guangzhou University of Traditional Chinese Medicine'}, 'officialTitle': 'AISTCM-The Pathological Pattern Differentiation and Outcome Measurement of Acute Ischemic Stroke Treated With Traditional Chinese Medicine', 'orgStudyIdInfo': {'id': '2004BA721A02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Chinese herbal medicine', 'interventionNames': ['Drug: Erigeron breviscapus injection', 'Drug: hua tuo zai zao wan (a herbal medicine pill)', 'Drug: Compound stroke herbal medicine (8 herbal)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo'}], 'interventions': [{'name': 'Erigeron breviscapus injection', 'type': 'DRUG', 'armGroupLabels': ['Chinese herbal medicine']}, {'name': 'hua tuo zai zao wan (a herbal medicine pill)', 'type': 'DRUG', 'armGroupLabels': ['Chinese herbal medicine']}, {'name': 'Compound stroke herbal medicine (8 herbal)', 'type': 'DRUG', 'armGroupLabels': ['Chinese herbal medicine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100700', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Dongzhimen Hospital of Beijing University of Traditional Chinese Medicine', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '528000', 'city': 'Foshan', 'state': 'Guangdong', 'country': 'China', 'facility': 'Foshan Hospital of Traditional Chinese Medicine', 'geoPoint': {'lat': 23.02677, 'lon': 113.13148}}, {'zip': '510120', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': '2nd hospital of Zhongshan University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '510120', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Neurology Center, Guangdong Province Hospital of Tradtional Chinese Medicine', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'city': 'Zhongshan', 'state': 'Guangdong', 'country': 'China', 'facility': 'Zhongshan Hospital of Traditional Chinese Medicine', 'geoPoint': {'lat': 22.52306, 'lon': 113.37912}}, {'zip': '530011', 'city': 'Nanning', 'state': 'Guangxi', 'country': 'China', 'facility': 'Ruikang Hospital of Traditional Chinese Medicine', 'geoPoint': {'lat': 22.81667, 'lon': 108.31667}}, {'zip': '530023', 'city': 'Nanning', 'state': 'Guangxi', 'country': 'China', 'facility': '1st Hospital of Guangxi college of Traditional Chinese Medicine', 'geoPoint': {'lat': 22.81667, 'lon': 108.31667}}, {'zip': '450006', 'city': 'Zhengzhou', 'state': 'Henan', 'country': 'China', 'facility': "The 1st Hospital of He'nan College of Traditional Chinese Medicine", 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}, {'zip': '430006', 'city': 'Wuhan', 'state': 'Hubei', 'country': 'China', 'facility': 'The teahing hospital of Hubei College of Traditional Chinese Medicine', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'city': 'Taizhou', 'state': 'Jiangsu', 'country': 'China', 'facility': 'Taizhou Hospital of Traditional Chinese Medicine', 'geoPoint': {'lat': 32.49069, 'lon': 119.90812}}, {'city': 'Jinan', 'state': 'Shandong', 'country': 'China', 'facility': 'Jinan Hospital of Traditional Chinese Medicine', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}, {'zip': '200000', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Longhua Hospital of Shanghai University of Traditional Chinese Medicine', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '200000', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Shanghai Hospital of Traditional Chinese Medicine', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '200000', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Shuguang Hospital of Shanghai University of Traditional Chinese Medicine', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '200000', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Yueyang Hospital of Shanghai University of Traditional Chinese Medicine', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '200032', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'zhongshan hospital of Fudan Unversity', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '200040', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Huashan Hospital of Fudan Unveristy', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '712000', 'city': 'Xian Yang', 'state': 'Shanxi', 'country': 'China', 'facility': 'The Hosptial of Shanxi College of Traditional Chinese Medicine'}, {'zip': '610072', 'city': 'Chengdu', 'state': 'Sichuan', 'country': 'China', 'facility': "The People's Hospital of Sichuan Province", 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}, {'zip': '830001', 'city': 'Ürümqi', 'state': 'Xinjiang', 'country': 'China', 'facility': 'Xinjiang Uygur Autonomous Region Hospital of Traditional Chinese Medicine', 'geoPoint': {'lat': 43.80096, 'lon': 87.60046}}, {'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'Zhejiang Province Hospital of Traditional Chinese Medicine', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'city': 'Wenzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'The 2nd Hospital of Wenzhou Medical College', 'geoPoint': {'lat': 27.99942, 'lon': 120.66682}}], 'overallOfficials': [{'name': 'Longhui Yang, Chairmam', 'role': 'STUDY_CHAIR', 'affiliation': 'Branch of Science and Education'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Guangzhou University of Traditional Chinese Medicine', 'class': 'OTHER'}}}}