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

Cerebral Infarction Clinical Trial

Official title:

AISTCM-The Pathological Pattern Differentiation and Outcome Measurement of Acute Ischemic Stroke Treated With Traditional Chinese Medicine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00351806
• Other study ID #: 2004BA721A02
• Status: Completed
• Phase: Phase 4
• First received: July 12, 2006
• Last updated: August 5, 2013
• Start date: July 2005
• Est. completion date: November 2006

Study information

• Verified date: August 2013
• Source: Guangzhou University of Traditional Chinese Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Science & Technology (MOST) of the People's Republic of China
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: November 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 85 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cerebral Infarction
• Infarction

Intervention

Drug:
• Erigeron breviscapus injection

• hua tuo zai zao wan (a herbal medicine pill)

• Compound stroke herbal medicine (8 herbal)

Locations

Country	Name	City	State
China	Dongzhimen Hospital of Beijing University of Traditional Chinese Medicine	Beijing	Beijing
China	The People's Hospital of Sichuan Province	Chengdu	Sichuan
China	Foshan Hospital of Traditional Chinese Medicine	Foshan	Guangdong
China	2nd hospital of Zhongshan University	Guangzhou	Guangdong
China	Neurology Center, Guangdong Province Hospital of Tradtional Chinese Medicine	Guangzhou	Guangdong
China	Zhejiang Province Hospital of Traditional Chinese Medicine	Hangzhou	Zhejiang
China	Jinan Hospital of Traditional Chinese Medicine	Jinan	Shandong
China	Ruikang Hospital of Traditional Chinese Medicine	Nan Ning	Guangxi
China	1st Hospital of Guangxi college of Traditional Chinese Medicine	Nanning	Guangxi
China	Huashan Hospital of Fudan Unveristy	Shanghai	Shanghai
China	Longhua Hospital of Shanghai University of Traditional Chinese Medicine	Shanghai	Shanghai
China	Shanghai Hospital of Traditional Chinese Medicine	Shanghai	Shanghai
China	Shuguang Hospital of Shanghai University of Traditional Chinese Medicine	Shanghai	Shanghai
China	Yueyang Hospital of Shanghai University of Traditional Chinese Medicine	Shanghai	Shanghai
China	zhongshan hospital of Fudan Unversity	Shanghai	Shanghai
China	Taizhou Hospital of Traditional Chinese Medicine	Taizhou	Jiangsu
China	Xinjiang Uygur Autonomous Region Hospital of Traditional Chinese Medicine	Urumqi	Xinjiang
China	The 2nd Hospital of Wenzhou Medical College	Wenzhou	Zhejiang
China	The teahing hospital of Hubei College of Traditional Chinese Medicine	Wuhan	Hubei
China	The Hosptial of Shanxi College of Traditional Chinese Medicine	Xian yang	Shanxi
China	The 1st Hospital of He'nan College of Traditional Chinese Medicine	Zhengzhou	Henan
China	Zhongshan Hospital of Traditional Chinese Medicine	Zhongshan	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Guangzhou University of Traditional Chinese Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	death rate, Barthel Index
Secondary	Glasgow Outcome Scale (GOS)
Secondary	Modified Rankin Scale (mRS)
Secondary	National Institute of Health Stroke Scale (NIHSS)
Secondary	Stroke Specific Quality of Life (SSQOL)
Secondary	Scale of Traditional Chinese Medicine (SSTCM)