The Secondary Prevention Trial for Ischemic Stroke With DengzhanShengmai Capsule

Study Overview
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Brief Summary
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In order to observe the secondary preventive effect of the Dengzhanshengmai capsule on ischemic stroke, the investigators hold the large randomized control trial (RCT). 3143 subjects are included in 83 clinical research centers all over China. The subjects are randomly grouped into two groups. The basic therapy included antiplatelet aggregation, stroke health education, management of blood pressure, blood lipid and blood glucose, etc. The treating group will take the compound Chinese Medicine Deng Zhan Sheng Mai capsule and the contrast group will take the placebo for twelve months. Then all of the subjects are visited on the 30th, 90th, 180th, 360th day after inclusion. The recurrence of stroke, cardiovascular events, and peripheral arterial events are observed.

Detailed Description
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Objective:To observe the secondary clinical effect of the Deng Zhan Sheng Mai capsule on ischemic stroke patients. Methods:3143 subjects suffering from acute ischemic stroke are included in 83 clinical research centers all over China. The subjects are randomly divided into two groups:The treating group and the placebo group.Both groups accept the basic therapy and test drug.The basic therapy included antiplatelet aggregation,stroke health education,management of blood pressure,blood lipid and blood glucose,etc.The patients in Dengzhan Shengmaigroup take Deng Zhan Sheng Mai capsule and the placebo group take the placebo drug for twelve months.Then all of the subjects are visited on the 30th,90th,180th,360th day after inclusion. Primary endpoints(cerebral infarction,intracerebral hemorrhage,subarachnoid hemorrhage) and secondary endpoints(cardiovascular events,peripheral arterial disease),functional disability are observed at each follow up.

Official Title
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Model Study on the Comprehensive Treating Protocol and Effect Evaluation of Ischemic Stroke With Traditional Chinese Medicine

Conditions
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Stroke

Intervention / Treatment
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* Drug: Dengzhan Shengmai capsule
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 40-75 years old Ischemic stroke diagnosed by CT/MRI scan Patient presenting from 14 days to 6 months of first onset of ischemic stroke Presence of at least one risk factor of stroke (such as hypertension, diabetes mellitus, coronary heart disease, hyperlipidemia, and smoking, etc.) that can be interfered in Informed consent Exclusion Criteria: Silent cerebral infarction Cerebral infarction due to other causes except artery scleroses (i.e. cardiogenic embolism, hypercoagulable state, endangium stripping, vasculitis) Presence of serious heart disease, heart, liver, lung, and kidney functional failure; malignancy; alimentary tract hemorrhage mental disorder and noncooperation with physician Females during pregnancy or lactation Already attend other clinical trial

Ages Eligible for Study
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Minimum Age: 40 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dengzhan Shengmai capsule<br>Dengzhan Shengmai capsule 0.18g by mouth twice a day for 1year | Drug: Dengzhan Shengmai capsule<br>* Capsule, 0.18g, 2#, Bid*1year<br>* Other names: DZSM;|
| Placebo Comparator: Placebo<br>Placebo 0.18g by mouth twice a day for 1year | Drug: placebo<br>* Capsule, 0.18g, 2#, Bid*1year<br>* Other names: DZSMP;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| recurrence of stroke |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence rate of cardiovascular events, and peripheral arterial events |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recurrence of stroke, Dengzhan Shengmai Capsule, Traditional Chinese Medicine