Efficiency Study of Traditional Chinese Medicine (TCM) Versus Western Medicine (WM) on Ischemic Stroke

Study Overview
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Brief Summary
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Complex project of Traditional Chinese Medicine (TCM) with Western Medicine (WM) project under stroke unit mode contrast,assuming that the efficiency of TCM on early rehabilitation and secondary prevention of ischemic stroke is same or better than that of WM.

Detailed Description
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As a multi-site randomized controlled clinical trial,through a central system,patients were randomly assigned to the intervention group or the control group.In the intervention group, patients were treated with the traditional Chinese medicine comprehensive rehabilitation program, which includes traditional Chinese medicine syndrome differentiation herbs, Chinese medicine injection, wash foam Chinese medicine, acupuncture,massage, and Chinese medicine health education. In the control group, patients were treated with Western-based treatment plus modern rehabilitation techniques.All patients were treated for 2 weeks. At the first day after the treatment and the 14 days after treatment, each patient was evaluated for the following three clinical indications: (1)evaluation of neurological deficits by U.S. National Institutes of Health Stroke Scale (NIHSS);(2) evaluation of motor function by the short form Fugl-Meyer motor function scoring system (FMI); and (3) assessment of limb spasticity by the modified Ashworth spasticity rating scale.

Official Title
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Program of TCM on Early Rehabilitation and Secondary Prevention of Ischemic Stroke

Conditions
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Stroke

Intervention / Treatment
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* Other: acupuncture, massage and basic TCM treatment
* Other: rehabilitation and WM basic treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: According with the stroke diagnosis of Traditional Chinese Medicine According to atherosclerotic thrombotic cerebral infarction from Western diagnosis such as medical history and CT / MRI examinations It has attacked in 7 days The assessment of scale of NIHSS:4-24 points Age: ≥ 35 years and ≤ 75 years Patients or their legal guardians sign informed consent form Exclusion Criteria: The patients with ICH or cerebral hemorrhage or TIA It has attacked beyond 7 days Patients with stroke history and the mRS ≥ 2 points before this attack Mixed type of stroke (infarction after bleeding or bleeding after infarction) Patients with cerebral infarction by cardiogenic embolism, blood hypercoagulable state and tunica intima exfoliating Patients with serious heart disease;failure of heart or liver or kidney; cancer;digestive tract bleeding Women of pregnancy or breast-feeding Patients who are taking part in other clinical trials that will influence the results of this study

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 75 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: TCM integrated group<br>800 patients with acupuncture, massage and basic Chinese medicine treatment | Other: acupuncture, massage and basic TCM treatment<br>* During hospitalization:Patients accept TCM rehabilitation and basic treatment including WM basic treatment and Chinese medicine injection,decoction,herb soak treatment and health education. After discharge from hospital: In the TCM group,add prescriptions according to two conditions:a. patients using A injection (one Chinese herb injection admitted by SFDA) will take A' capsule (one Chinese herb capsule admitted by SFDA) for 6 months;b.patients using B injection (ditto) will take B' capsule (ditto) for 6 months.Both of them will accept TCM health education.In the WM group, patients are suggested with targeted rehabilitation programs according to different causes.<br>* Other names: 863 TCM project for ischemic stroke-TCM group;|
| Active Comparator: Western Medicine group<br>400 patients with modern rehabilitation techniques and Western Medicine basic treatment | Other: rehabilitation and WM basic treatment<br>* there two steps: during hospitalization: patients accept modern rehabilitation and basic treatment of life supporting and medicine using and health education After discharge: make rehabilitation plans for patients including management of anticoagulant drugs, blood pressure, blood lipid and blood glucose, health education, and some suggestions for resisting alcohol ,smoking and reasonable diet<br>* Other names: 863 TCM project for ischemic stroke-WM group;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NIHSS Stroke Scale, relapse rate |  | 360 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| adverse event |  | 360 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stroke, Traditional Chinese Medicine, Rehabilitation