AISTCM-Outcome Measurement of Acute Ischemic Stroke With Traditional Chinese Medicine - Full Text View

Sponsored by:	Guangzhou University of Traditional Chinese Medicine
Information provided by:	Guangzhou University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier:	NCT00351806

Purpose

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.

Condition	Intervention	Phase
Cerebral Infarction	Drug: Erigeron breviscapus injection Drug: hua tuo zai zao wan (a herbal medicine pill) Drug: Compound stroke herbal medicine (8 herbal)	Phase IV

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	AISTCM-The Pathological Pattern Differentiation and Outcome Measurement of Acute Ischemic Stroke Treated With Traditional Chinese Medicine

Further study details as provided by Guangzhou University of Traditional Chinese Medicine:

Primary Outcome Measures:

death rate, Barthel Index

Secondary Outcome Measures:

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)

Estimated Enrollment:	500
Study Start Date:	July 2005
Estimated Study Completion Date:	November 2006

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

Ages Eligible for Study:	40 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00351806

Locations

China
Dongzhimen Hospital of Beijing University of Traditional Chinese Medicine
Beijing, China, 100700
Shanghai Hospital of Traditional Chinese Medicine
Shanghai, China, 200000
Huashan Hospital of Fudan Unveristy
shanghai, China, 200040
zhongshan hospital of Fudan Unversity
shanghai, China, 200032
Shuguang Hospital of Shanghai University of Traditional Chinese Medicine
Shanghai, China, 200000
Yueyang Hospital of Shanghai University of Traditional Chinese Medicine
Shanghai, China, 200000
Longhua Hospital of Shanghai University of Traditional Chinese Medicine
shanghai, China, 200000
China, Guangdong
Neurology Center, Guangdong Province Hospital of Tradtional Chinese Medicine
Guangzhou, Guangdong, China, 510120
Foshan Hospital of Traditional Chinese Medicine
Foshan, Guangdong, China, 528000
Zhongshan Hospital of Traditional Chinese Medicine
Zhongshan, Guangdong, China
2nd hospital of Zhongshan University
guangzhou, Guangdong, China, 510120
China, Guangxi
1st Hospital of Guangxi college of Traditional Chinese Medicine
nanning, Guangxi, China, 530023
Ruikang Hospital of Traditional Chinese Medicine
Nan-ning, Guangxi, China, 530011
China, Henan
The 1st Hospital of He'nan College of Traditional Chinese Medicine
Zhengzhou, Henan, China, 450006
China, Hubei
The teahing hospital of Hubei College of Traditional Chinese Medicine
Wuhan, Hubei, China, 430006
China, Jiangsu
Taizhou Hospital of Traditional Chinese Medicine
Taizhou, Jiangsu, China
China, Shandong
Jinan Hospital of Traditional Chinese Medicine
Jinan, Shandong, China
China, Shanxi
The Hosptial of Shanxi College of Traditional Chinese Medicine
Xian yang, Shanxi, China, 712000
China, Si Chuan
The People's Hospital of Sichuan Province
Chengdu, Si Chuan, China, 610072
China, Xin jiang
Xinjiang Uygur Autonomous Region Hospital of Traditional Chinese Medicine
Urumqi, Xin jiang, China, 830001
China, Zhejiang
Zhejiang Province Hospital of Traditional Chinese Medicine
Hangzhou, Zhejiang, China
The 2nd Hospital of Wenzhou Medical College
Wenzhou, Zhejiang, China

Sponsors and Collaborators

Guangzhou University of Traditional Chinese Medicine

Investigators

Study Chair:

Longhui Yang, Chairmam

Branch of Science and Education

More Information

Study ID Numbers:	2004BA721A02
Study First Received:	July 12, 2006
Last Updated:	October 21, 2007
ClinicalTrials.gov Identifier:	NCT00351806
Health Authority:	China: Ministry of Science & Technology (MOST) of the People's Republic of China

Keywords provided by Guangzhou University of Traditional Chinese Medicine:

acute intracerebral infarction

Study placed in the following topic categories:

Necrosis
Cerebral Infarction
Stroke
Vascular Diseases
Central Nervous System Diseases
Brain Ischemia

Brain Infarction
Ischemia
Brain Diseases
Infarction
Cerebrovascular Disorders

Additional relevant MeSH terms:

Pathologic Processes
Nervous System Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 14, 2009