Clinical trial NCT00351806: AISTCM-Outcome Measurement of Acute Ischemic Stroke With Traditional Chinese Medicine
Official title: AISTCM-The Pathological Pattern Differentiation and Outcome Measurement of Acute Ischemic Stroke Treated With Traditional Chinese Medicine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cerebral Infarction
Keywords: acute intracerebral infarction
Lead sponsor: Guangzhou University of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2006-07-13
Enrollment: 500
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Ischemic stroke diagnosis by CT/MRI scan
* Yin pattern of Traditional Chinese Medicine Theory
* 40-85 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: death rate, Barthel Index
Secondary outcomes:
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)
Other outcomes:
Locations:
city: Beijing
country: China
facility: Dongzhimen Hospital of Beijing University of Traditional Chinese Medicine
state: Beijing
city: Foshan
country: China
facility: Foshan Hospital of Traditional Chinese Medicine
state: Guangdong
city: Guangzhou
country: China
facility: 2nd hospital of Zhongshan University
state: Guangdong
city: Guangzhou
country: China
facility: Neurology Center, Guangdong Province Hospital of Tradtional Chinese Medicine
state: Guangdong
city: Zhongshan
country: China
facility: Zhongshan Hospital of Traditional Chinese Medicine
state: Guangdong
city: Nan Ning
country: China
facility: Ruikang Hospital of Traditional Chinese Medicine
state: Guangxi
city: Nanning
country: China
facility: 1st Hospital of Guangxi college of Traditional Chinese Medicine
state: Guangxi
city: Zhengzhou
country: China
facility: The 1st Hospital of He'nan College of Traditional Chinese Medicine
state: Henan
city: Wuhan
country: China
facility: The teahing hospital of Hubei College of Traditional Chinese Medicine
state: Hubei
city: Taizhou
country: China
facility: Taizhou Hospital of Traditional Chinese Medicine
state: Jiangsu
city: Jinan
country: China
facility: Jinan Hospital of Traditional Chinese Medicine
state: Shandong
city: Shanghai
country: China
facility: Longhua Hospital of Shanghai University of Traditional Chinese Medicine
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Hospital of Traditional Chinese Medicine
state: Shanghai
city: Shanghai
country: China
facility: Shuguang Hospital of Shanghai University of Traditional Chinese Medicine
state: Shanghai
city: Shanghai
country: China
facility: Yueyang Hospital of Shanghai University of Traditional Chinese Medicine
state: Shanghai
city: Shanghai
country: China
facility: zhongshan hospital of Fudan Unversity
state: Shanghai
city: Shanghai
country: China
facility: Huashan Hospital of Fudan Unveristy
state: Shanghai
city: Xian yang
country: China
facility: The Hosptial of Shanxi College of Traditional Chinese Medicine
state: Shanxi
city: Chengdu
country: China
facility: The People's Hospital of Sichuan Province
state: Sichuan
city: Urumqi
country: China
facility: Xinjiang Uygur Autonomous Region Hospital of Traditional Chinese Medicine
state: Xinjiang
city: Hangzhou
country: China
facility: Zhejiang Province Hospital of Traditional Chinese Medicine
state: Zhejiang
city: Wenzhou
country: China
facility: The 2nd Hospital of Wenzhou Medical College
state: Zhejiang
Study officials:
affiliation: Branch of Science and Education
name: Longhui Yang, Chairmam
role: STUDY_CHAIR
References:
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.