AISTCM-Outcome Measurement of Acute Ischemic Stroke With Traditional Chinese Medicine
AISTCM-The Pathological Pattern Differentiation and Outcome Measurement of Acute Ischemic Stroke Treated With Traditional Chinese Medicine
1 other identifier
interventional
500
1 country
22
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jul 2005
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2005
CompletedFirst Submitted
Initial submission to the registry
July 12, 2006
CompletedFirst Posted
Study publicly available on registry
July 13, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2006
CompletedAugust 7, 2013
August 1, 2013
July 12, 2006
August 5, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
death rate, Barthel Index
Secondary Outcomes (5)
Glasgow Outcome Scale (GOS)
Modified Rankin Scale (mRS)
National Institute of Health Stroke Scale (NIHSS)
Stroke Specific Quality of Life (SSQOL)
Scale of Traditional Chinese Medicine (SSTCM)
Study Arms (2)
Chinese herbal medicine
EXPERIMENTALplacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Ischemic stroke diagnosis by CT/MRI scan
- Yin pattern of Traditional Chinese Medicine Theory
- years old
- Total anterior circulation infarcts (TACI), partial anterior territory cerebral infarction (PACI), lacunar anterior circulation infarcts (LACI) type under Oxfordshire Community Stroke Project (OCSP) standard
- NIHSS \>=4;
- Glasgow coma scale (GCS) \>=7;
- Modified Rankin Scale less than 2 degrees before onset of this stroke
- Informed consent signed by patient or his/her family
You may not qualify if:
- Hemorrhagic stroke;
- Coma, GCS\<=7;
- Cerebral hernia;
- Serious heart, liver, lung, kidney functional failure;
- Gastrointestinal (GI) bleeding;
- Thrombolysis drugs or surgery was administrated to the patient;
- Not cooperative with physician;
- Psychological disorder;
- Already taken part in other clinical drug trial within the past 3 months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (22)
Dongzhimen Hospital of Beijing University of Traditional Chinese Medicine
Beijing, Beijing Municipality, 100700, China
Foshan Hospital of Traditional Chinese Medicine
Foshan, Guangdong, 528000, China
2nd hospital of Zhongshan University
Guangzhou, Guangdong, 510120, China
Neurology Center, Guangdong Province Hospital of Tradtional Chinese Medicine
Guangzhou, Guangdong, 510120, China
Zhongshan Hospital of Traditional Chinese Medicine
Zhongshan, Guangdong, China
Ruikang Hospital of Traditional Chinese Medicine
Nanning, Guangxi, 530011, China
1st Hospital of Guangxi college of Traditional Chinese Medicine
Nanning, Guangxi, 530023, China
The 1st Hospital of He'nan College of Traditional Chinese Medicine
Zhengzhou, Henan, 450006, China
The teahing hospital of Hubei College of Traditional Chinese Medicine
Wuhan, Hubei, 430006, China
Taizhou Hospital of Traditional Chinese Medicine
Taizhou, Jiangsu, China
Jinan Hospital of Traditional Chinese Medicine
Jinan, Shandong, China
Longhua Hospital of Shanghai University of Traditional Chinese Medicine
Shanghai, Shanghai Municipality, 200000, China
Shanghai Hospital of Traditional Chinese Medicine
Shanghai, Shanghai Municipality, 200000, China
Shuguang Hospital of Shanghai University of Traditional Chinese Medicine
Shanghai, Shanghai Municipality, 200000, China
Yueyang Hospital of Shanghai University of Traditional Chinese Medicine
Shanghai, Shanghai Municipality, 200000, China
zhongshan hospital of Fudan Unversity
Shanghai, Shanghai Municipality, 200032, China
Huashan Hospital of Fudan Unveristy
Shanghai, Shanghai Municipality, 200040, China
The Hosptial of Shanxi College of Traditional Chinese Medicine
Xian Yang, Shanxi, 712000, China
The People's Hospital of Sichuan Province
Chengdu, Sichuan, 610072, China
Xinjiang Uygur Autonomous Region Hospital of Traditional Chinese Medicine
Ürümqi, Xinjiang, 830001, China
Zhejiang Province Hospital of Traditional Chinese Medicine
Hangzhou, Zhejiang, China
The 2nd Hospital of Wenzhou Medical College
Wenzhou, Zhejiang, China
Related Publications (1)
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.
PMID: 20456839DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Longhui Yang, Chairmam
Branch of Science and Education
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
July 12, 2006
First Posted
July 13, 2006
Study Start
July 1, 2005
Study Completion
November 1, 2006
Last Updated
August 7, 2013
Record last verified: 2013-08