Curative Efficacy of Secondary Prevention for Patients With Ischemic Stroke Through Syndrome Differentiation of TCM
- Conditions
- Ischemic Stroke
- Interventions
- Drug: PlaceboDrug: Naoxintong Capsule
- Registration Number
- NCT02334969
- Lead Sponsor
- Xiaofei Yu
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2200
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control group Placebo 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 Experimental group Naoxintong Capsule On the basis of the secondary prevention of ischemic stroke，Volunteers will be taken Naoxintong capsule, 2 times a day, three granule per time
- Primary Outcome Measures
Name Time Method Stroke recurrence rate and Stroke mortality 2 years Stroke recurrence rate and Stroke mortality
- Secondary Outcome Measures
Name Time Method All-cause mortality 2 years All-cause mortality
The incidence rate of myocardial infarction 2 years The incidence rate of myocardial infarction
Trial Locations
- Locations (24)
Shuguang Hospital affliated to Shanghai University of Traditional Chinese Medicine
🇨🇳Shanghai, Shanghai, China
Longhua Hospital affliated to Shanghai University of Traditional Chinese Medicine
🇨🇳Shanghai, Shanghai, China
Huashan Hospital affliated to Fudan University
🇨🇳Shanghai, Shanghai, China
Shanghai fifth People's Hospital affliated to Fudan University
🇨🇳Shanghai, Shanghai, China
Shanghai Chinese Medicine Hospital
🇨🇳Shanghai, Shanghai, China
Qingpu Branch of Zhongshan Hospital affliated to Fudan University
🇨🇳Shanghai, Shanghai, China
Shanghai seventh People's Hospital
🇨🇳Shanghai, Shanghai, China
Tongren Hospital affliated to Shanghai Jiao Tong University
🇨🇳Shanghai, Shanghai, China
Tongji Hospital
🇨🇳Shanghai, Shanghai, China
Shanghai tenth People's Hospital
🇨🇳Shanghai, Shanghai, China
Shanghai Putuo Central Hospital
🇨🇳Shanghai, Shanghai, China
Changning Tongren Hospital of Shanghai
🇨🇳Shanghai, Shanghai, China
Changhai Hospital
🇨🇳Shanghai, Shanghai, China
Pudong Hospital of Traditional Chinese Medicine
🇨🇳Shanghai, Shanghai, China
Shanghai third People's Hospital affliated to Shanghai Jiao Tong University
🇨🇳Shanghai, Shanghai, China
East Branch of Shanghai sixth People's Hospital
🇨🇳Shanghai, Shanghai, China
Shanghai Ninth People's Hospital affliated to Shanghai Jiao Tong University Shool of Medcine
🇨🇳Shanghai, Shanghai, China
North Branch of Ruijin Hospital affliated to Shanghai Jiao Tong University
🇨🇳Shanghai, Shanghai, China
Zhongshan Hospital affliated to Fudan University
🇨🇳Shanghai, Shanghai, China
Pudong Gong Li Hospital of Shanghai
🇨🇳Shanghai, Shanghai, China
Shanghai sixth People's Hospital affliated to Shanghai Jiao Tong University
🇨🇳Shanghai, Shanghai, China
Shanghai Hospital of Integrative Medicine
🇨🇳Shanghai, Shanghai, China
Xinhua Hospital affliated to Shanghai Jiao Tong University Shool of Medcine
🇨🇳Shanghai, Shanghai, China
Dongfang Hospital affliated to Tongji University
🇨🇳Shanghai, Shanghai, China