The Secondary Prevention Trial for Ischemic Stroke With DengzhanShengmai Capsule
- Conditions
- Stroke
- Interventions
- Drug: Dengzhan Shengmai capsuleDrug: placebo
- Registration Number
- NCT00548223
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 3143
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Dengzhan Shengmai capsule Dengzhan Shengmai capsule Dengzhan Shengmai capsule 0.18g by mouth twice a day for 1year Placebo placebo Placebo 0.18g by mouth twice a day for 1year
- Primary Outcome Measures
Name Time Method recurrence of stroke 1 year
- Secondary Outcome Measures
Name Time Method incidence rate of cardiovascular events, and peripheral arterial events 1 year
Trial Locations
- Locations (84)
First Hospital of Handan City, Hebei Province
π¨π³Handan, Hebei, China
First Hospital of Wuhan City
π¨π³Wuhan, Hubei, China
Chinese medicine hospital in Foshan city
π¨π³Foshan, Guangdong, China
Anhui College of Traditional Chinese Medicine First Affiliated Hospital
π¨π³Hefei, Anhui, China
Xuanwu Hospital of Capital University of Medical Sciences
π¨π³Beijing, Beijing, China
First Affiliated Hospital of Fujian Medical University
π¨π³Fuzhou, Fujian, China
Chinese medicine hospital Conghua City
π¨π³Conghua, Guangdong, China
Dongguan City Chinese medicine hospital
π¨π³Dongguan, Guangdong, China
Foshan First People's Hospital
π¨π³Foshan, Guangdong, China
Integrated Hospital in Guangdong Province
π¨π³Foshan, Guangdong, China
Foshan Shunde Area Integrated Hospital in Guangdong Province
π¨π³Foshan, Guangdong, China
The second Chinese medicine hospital in Guangdong Province
π¨π³Guangzhou, Guangdong, China
Guangdong Province Hospital of Tradtional Chinese Medicine
π¨π³Guangzhou, Guangdong, China
Second Affiliated Hospital of Zhongshan University
π¨π³Guangzhou, Guangdong, China
Chinese medicine hospital in Liwan District of Guangzhou City
π¨π³Guangzhou, Guangdong, China
Yuexiu area Hospital of TCM in Guangzhou
π¨π³Guangzhou, Guangdong, China
Third Affiliated Hospital of Guangzhou Medical College
π¨π³Guangzhou, Guangdong, China
Nanfang Hospital, Southern Medical University
π¨π³Guangzhou, Guangdong, China
Third Affiliated Hospital of Zhongshan University
π¨π³Guangzhou, Guangdong, China
People's Hospital of Huizhou City Center
π¨π³Huizhou, Guangdong, China
Huizhou People Hospital in Guangdong Province
π¨π³Huizhou, Guangdong, China
Chinese medicine hospital in Maoming City
π¨π³Maoming, Guangdong, China
Shenzhen City People's Hospital
π¨π³Shenzhen, Guangdong, China
Taishan Hospital of TCM in Guangdong Province
π¨π³Taishan, Guangdong, China
Yangjiang Hospital of TCM in Guangdong Province
π¨π³Yangjiang, Guangdong, China
Xinxing Hospitla of TCM in Guangdong Province
π¨π³Yunfu, Guangdong, China
Chinese medicine hospital in Zhongshan City, Guangdong Province
π¨π³Zhongshan, Guangdong, China
First Affiliated Hospital of Guangxi College of Traditional Chinese Medicine
π¨π³Nanning, Guangxi, China
Guangxi Wuzhou Red Cross Hospital
π¨π³Wuzhou, Guangxi, China
The First Affiliated Hospital of Henan College of Traditional Chinese Medicine
π¨π³Zhengzhou, Henan, China
Chinese medicine hospital in Hubei Province
π¨π³Wuhan, Hubei, China
Ankang Hospital of TCM in Shanxi Province
π¨π³Ankang, Shanxi, China
Liaoning University of Traditional Chinese Medicine Affiliated Hospital
π¨π³Shenyang, Liaoning, China
Chinese Medicine Hospital of Jinan City
π¨π³Jinan, Shandong, China
Subsidiary of Shanghai University of Traditional Chinese Medicine, Longhua Hospital
π¨π³Shanghai, Shanghai, China
Qishan Hospital in Shanxi Province
π¨π³Qishan, Shanxi, China
Chinese medicine hospital in Xi'an
π¨π³Xi'an, Shanxi, China
The Affiliated Hospital of Chengdu University of Traditional Chinese Medicine
π¨π³Chengdu, Sichuan, China
Guangyuan Hospital of TCM in Sichuan Province
π¨π³Guangyuan, Sichuan, China
Chinese medicine hospital in Hangzhou
π¨π³Hangzhou, Zhejiang, China
Tiantan Hospital Capital University of Medical Sciences
π¨π³Beijing, China
The First Affiliated Hospital of Guangzhou Medical College
π¨π³Guangzhou, Guangdong, China
Guangzhou Red Cross Hospital
π¨π³Guangzhou, Guangdong, China
Jiangmen Wuyi Chinese medicine hospital
π¨π³Jiangmen, Guangdong, China
Xinhui Hospital of TCM in Guangdong Province
π¨π³Xinhui, Guangdong, China
Liuzhou Hospital of TCM in Guangxi
π¨π³Liuzhou, Guangxi, China
Chinese medicine hospital in Zhuhai, Guangdong Province Hospital
π¨π³Zhuhai, Guangdong, China
Ruikang Hospital Guangxi College of Traditional Chinese Medicine
π¨π³Nanning, Guangxi, China
Chinese medicine hospital in Zhengzhou City in Henan Province
π¨π³Zhengzhou, Henan, China
Henan Province, the Third Affiliated Hospital of College of Traditional Chinese Medicine
π¨π³Zhengzhou, Henan, China
Wuhan University People's Hospital
π¨π³Wuhan, Hubei, China
Hengyang Central Hospital
π¨π³Hengyang, Hunan, China
Xiangya Hospital Central South University
π¨π³Changsha, Hunan, China
The 169th Hospital of PLA
π¨π³Hengyang, Hunan, China
Lianyungang Hospital of TCM in Jiangsu Province
π¨π³Lianyungang, Jiangsu, China
Chinese medicine hospital in Jiangsu Province
π¨π³Nanjing, Jiangsu, China
Jiangsu Provincial People's Hospital
π¨π³Nanjing, Jiangsu, China
Affiliated Hospital of Nantong University
π¨π³Nantong, Jiangxi, China
Pudong New Area People Hospital in Shanghai
π¨π³Shanghai, Shanghai, China
The 2nd affiliated Hospital fo Shanxi college of TCM
π¨π³Taiyuan, Shanxi, China
Shaanxi Provincial People's Hospital
π¨π³Xi'an, Shanxi, China
Xi'an Central Hospital
π¨π³Xi'an, Shanxi, China
The Second Affiliated Hospital of Xi'an Jiaotong University Medical College
π¨π³Xi'an, Shanxi, China
Affiliated Hospital of Shaanxi College of Traditional Chinese Medicine
π¨π³Xianyang, Shanxi, China
Anyue Hospital of TCM in Sichuan Province
π¨π³Anyue, Sichuan, China
Chengdu Integrated Hospital
π¨π³Chengdu, Sichuan, China
West China Hospital of Sichuan University
π¨π³Chengdu, Sichuan, China
People's Hospital of Sichuan Province
π¨π³Chengdu, Sichuan, China
Leshan City People's Hospital
π¨π³Leshan, Sichuan, China
The 2nd People Hospital of Chengdu City
π¨π³Chengdu, Sichuan, China
Jianyang Hospital of TCM in Sichuang Province
π¨π³Jianyang, Sichuan, China
Mianyang Hospital of TCM in Sichuan Province
π¨π³Mianyang, Sichuan, China
Affiliated Hospital of North Sichuan Medical College
π¨π³Nanchong, Sichuan, China
The Affiliated Hospital of TCM of Luzhou Medical School
π¨π³Luzhou, Sichuan, China
Affiliated Hospital of Luzhou Medical College
π¨π³Luzhou, Sichuan, China
Wulumuqi Hospital of TCM
π¨π³Wulumuqi, Xinjiang, China
Ningbo City, Zhejiang Province zhongRui hospital
π¨π³Ningbo, Zhejiang, China
Xinjiang Medical University Affiliated Hospital of First Clinical
π¨π³Wulumuqi, Xinjiang, China
The First Affiliated Hospital of Zhejiang University of Traditional Chinese Medicine
π¨π³Hangzhou, Zhejiang, China
Zhejiang University School of Medicine Second Affiliated Hospital
π¨π³Hangzhou, Zhejiang, China
Subsidiary of Shanghai University of Traditional Chinese Medicine ,Shuguang Hospital
π¨π³Shanghai, China
The Second Affiliated Hospital of Chongqing Third Military Medical University
π¨π³Chongqing, China
Medical College of Shanghai Jiaotong University Yan Chai Hospital
π¨π³Shanghai, China
Shanghai Jiaotong University Medical College Ruijin Hospital
π¨π³Shanghai, China