Curative Efficacy of Secondary Prevention for Patients With Ischemic Stroke Through Syndrome Differentiation of TCM

Study Overview
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Brief Summary
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The purpose of this study is to assess the efficacy and safety of Naoxintong Capsule in the secondary prevention of ischemic stroke by the multi-center, randomized,double-blind，placebo-controlled trial design project.

Detailed Description
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The research employs a random, double-blind, multicenter, placebo parallel and controlled design to observe the clinical effect of Naoxintong capsule in the treatment in ischemic stroke of the blood stasis syndrome on the secondary prevention，which is funded by Science and Technology Commission of Shanghai Municipality.The therapeutic drug of the research is Naoxintong capsule on the market for treatment and prevention of stroke, applicable to stroke patients caused by qi deficiency, blood stasis and venation stasis.The research will be carried out in 24 hospitals.It is a total number of 2200 volunteers，who will meet the inclusion criteria other than the exclusion criteria and agree to participate in the research.Volunteers will be randomly assigned to the experimental group or the control group. The trial drug for the experimental group is Naoxintong capsule, while that for the control group is a kind of placebo capsule.Volunteers will be regularly followed up during the experimental period of 2 years. It will be to evaluate the clinical efficacy of Naoxintong capsule on the secondary prevention by the stroke recurrence and mortality.

Official Title
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A Multi-center, Randomized, Double-blind and Placebo-controlled Clinical Research of 2200 Cases in Improving Curative Effect of Secondary Prevention for Patients With Ischemic Stroke Through Syndrome Differentiation of TCM

Conditions
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Ischemic Stroke

Intervention / Treatment
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* Drug: Naoxintong Capsule
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult volunteers aged ≤ 90 years old, ≥18 years old； Conforming to the diagnostic criteria of cerebral infarction under the 2010 version of Chinese Guidelines for Treatment of Acute Ischemic Stroke； Conforming to diagnostic criteria of the stasis type of TCM on the ischemic stroke； The onset of acute cerebral infarction ≥ 10 days； Consciousness awake； Volunteers agree to accept the program and sign informed consent. Exclusion Criteria: Excluding the patients of the yin deficiency type of ischemic stroke.The diagnostic criteria of Yin deficiency type of ischemic stroke is that sudden onset of disease；being signs or symptoms of of neurological deficit；CT or MRI examination showing intracranial ischemic lesions；Scarlet tongue； The volunteers with severe heart diseases, cardiac insufficiency, hepatosis, renal insufficiency, respiratory failure, malignant tumour, alimentary tract hemorrhage, etc. who may fail to complete the two-year follow-up； Psychiatric patients； Pregnants and lactating women； Volunteers in other clinical trials； Volunteers who are not suitable for this clinical trial according to the researchers for other reasons.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group<br>On the basis of the secondary prevention of ischemic stroke，Volunteers will be taken Naoxintong capsule, 2 times a day, three granule per time | Drug: Naoxintong Capsule<br>* This is Naoxintong capsule,which is composed of Huangqi,Chishao,Danshen,Danggui, Chuanxiong,Taoren,Honghua,Ruxiang,Moyao,Jixueteng,Niuxi,Guizhi,Sangzhi,Dilong,Quanxie,etal.<br>* Other names: Chinese Herbal Compound;|
| Active Comparator: Control group<br>On the basis of the secondary prevention of ischemic stroke，Volunteers will be taken Placebo capsule，which is identical with Naoxintong capsule in the appearance, shape, color and content, 2 times a day, three granule per time | Drug: Placebo<br>* placebo capsule has the same as Naoxintong capsule in the appearance, shape,colour and content tinct.<br>* Other names: Placebo of Chinese Herbal Compound;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stroke recurrence rate and Stroke mortality | Stroke recurrence rate and Stroke mortality | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause mortality | All-cause mortality | 2 years | 
| The incidence rate of myocardial infarction | The incidence rate of myocardial infarction | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ischemic stroke；Naoxintong Capsule