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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cerebral Infarction

Intervention / Treatment
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* Drug: Erigeron breviscapus injection
* Drug: hua tuo zai zao wan (a herbal medicine pill)
* Drug: Compound stroke herbal medicine (8 herbal)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Chinese herbal medicine<br> | Drug: Erigeron breviscapus injection<br> <br> Drug: hua tuo zai zao wan (a herbal medicine pill)<br> <br> Drug: Compound stroke herbal medicine (8 herbal)<br> <br> |
| Placebo Comparator: placebo<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| death rate, Barthel Index |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acute intracerebral infarction