The Secondary Prevention Trial for Ischemic Stroke With DengzhanShengmai Capsule
NCT ID: NCT00548223
Last Updated: 2013-08-07
Study Results
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Basic Information
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COMPLETED
PHASE4
3143 participants
INTERVENTIONAL
2007-12-31
2011-01-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Dengzhan Shengmai capsule
Dengzhan Shengmai capsule 0.18g by mouth twice a day for 1year
Dengzhan Shengmai capsule
Capsule, 0.18g, 2#, Bid\*1year
Placebo
Placebo 0.18g by mouth twice a day for 1year
placebo
Capsule, 0.18g, 2#, Bid\*1year
Interventions
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Dengzhan Shengmai capsule
Capsule, 0.18g, 2#, Bid\*1year
placebo
Capsule, 0.18g, 2#, Bid\*1year
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
40 Years
75 Years
ALL
No
Sponsors
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Second Affiliated Hospital, School of Medicine, Zhejiang University
OTHER
Nanhai Hospital of Traditional Chinese Medicine
OTHER
People's hospital of Huizhou city
UNKNOWN
Taishan city hospital of TCM
UNKNOWN
Ruijin Hospital
OTHER
First Affiliated Hospital of Fujian Medical University
OTHER
Yangjiang City Hospital of TCM in Guangdong Province
UNKNOWN
Xinxing county hospital of TCM
UNKNOWN
Southern branch of yuexiu district hospital of TCM
UNKNOWN
Xinhui hospital of TCM of Jiangmen
UNKNOWN
Shanghai Pudong New Area People's Hospital
OTHER
People's hospital of Jianyang city
UNKNOWN
Luzhou Medical College
OTHER
Mianyang city hospital of TCM
UNKNOWN
Guangyuan city hospital of TCM of Sichuan Province
UNKNOWN
The Third Affiliated Hospital of Guangzhou Medical University
OTHER
Shunde district hospital of TCM
UNKNOWN
Shenzhen People's Hospital
OTHER
Anyue County Hospital of Traditional Chinese
OTHER
Chengdu Integrated TCM&Western Medicine Hospital
UNKNOWN
Guangzhou Red Cross Hospital
OTHER
Jiangsu Provincial People's Hospital
OTHER
Ankang Hospital of Traditional Chinese Medicine
OTHER
Qishan county hospital of shaanxi province
UNKNOWN
Zongrui Hospital
OTHER
First Affiliated Hospital of Xinjiang Medical University
OTHER
Lianyungang Chinese Medicine Hospital
UNKNOWN
Yufu City Hospital of TCM in Guangdong Province
UNKNOWN
169 Military Hospital of China
OTHER
Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
OTHER
The second affiliated hospital of shanxi college of TCM
UNKNOWN
URUMQI Hospital of Traditional Chinese Medicine
UNKNOWN
Hubei General Hospital
UNKNOWN
The People's Hospital of Leshan
OTHER
Guagnzhou Liwan district Hospital of TCM
UNKNOWN
Longhua Hospital
OTHER
Shanghai Jiao Tong University School of Medicine
OTHER
Hangzhou City Hospital of TCM
UNKNOWN
Dongguan city hospital of TCM
UNKNOWN
Liuzhou City hospital of TCM
UNKNOWN
Maoming city hospital of TCM
UNKNOWN
Beijing Tiantan Hospital
OTHER
Affiliated Hospital of Nantong University
OTHER
Xi'an city hospital of TCM
UNKNOWN
Jiangsu province hospital of TCM
UNKNOWN
The Third People's Hospital of Chengdu
OTHER
Huizhou Municipal Central Hospital
OTHER
Zhejiang Provincial Hospital of TCM
OTHER
The Second People's Hospital of Yibin
OTHER
Shanxi Provincial People's Hospital
OTHER_GOV
The First Affiliated Hospital of Guangzhou Medical University
OTHER
Guangxi Ruikang Hospital
OTHER
Third Affiliated Hospital, Sun Yat-Sen University
OTHER
First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
OTHER
Affiliated Hospital of North Sichuan Medical College
OTHER
Third Affiliated Hospital of Henan University of Traditional Chinese Medicine
OTHER
ZhuHai Hospital
OTHER
Nanfang Hospital, Southern Medical University
OTHER
West China Hospital
OTHER
Guangdong Second Provincial Traditional Chinese Medicine Hospital
INDUSTRY
Handan First Hospital
OTHER
The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine
OTHER
Conghua city hospital of TCM
UNKNOWN
The First Affiliated Hospital of Guangxi University of Chinese Medicine
UNKNOWN
Hubei Hospital of Traditional Chinese Medicine
OTHER
Jinan city hospital of TCM
UNKNOWN
Shaanxi Hospital of Traditional Chinese Medicine
OTHER
Suining People's Hospital
UNKNOWN
Wuzhou Red Cross Hospital
OTHER
Wuhan Interated ＆Western Hospital
UNKNOWN
Second Affiliated Hospital of Xi'an Jiaotong University
OTHER
Xi'an Central Hospital
OTHER
Zhengzhou City Hospital of Traditional Chinese Medicine
OTHER
Xiangya Hospital of Central South University
OTHER
Second Affiliated Hospital, Sun Yat-Sen University
OTHER
The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
OTHER
ShuGuang Hospital
OTHER
Zhongshan Hospital Of Traditional Chinese Medicine
OTHER
Foshan Hospital of Traditional Chinese Medicine
OTHER
Teaching Hospital of Chengdu University of TCM
UNKNOWN
Jiangmen Wuyi Hospital of Traditional Chinese Medicine
OTHER
Guangdong Provincial Hospital of Traditional Chinese Medicine
OTHER
Guangzhou University of Traditional Chinese Medicine
OTHER
Responsible Party
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jianwen guo, MD
Professor
Principal Investigators
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Yan Huang, Bachelor
Role: PRINCIPAL_INVESTIGATOR
Guangdong Provincial Hospital of Tradtional Chinese Medicine
Locations
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Anhui College of Traditional Chinese Medicine First Affiliated Hospital
Hefei, Anhui, China
Xuanwu Hospital of Capital University of Medical Sciences
Beijing, Beijing Municipality, China
First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China
Dongguan City Chinese medicine hospital
Dongguan, Guangdong, China
Chinese medicine hospital in Foshan city
Foshan, Guangdong, China
Foshan First People's Hospital
Foshan, Guangdong, China
Integrated Hospital in Guangdong Province
Foshan, Guangdong, China
Foshan Shunde Area Integrated Hospital in Guangdong Province
Foshan, Guangdong, China
The second Chinese medicine hospital in Guangdong Province
Guangzhou, Guangdong, China
Guangdong Province Hospital of Tradtional Chinese Medicine
Guangzhou, Guangdong, China
Second Affiliated Hospital of Zhongshan University
Guangzhou, Guangdong, China
The First Affiliated Hospital of Guangzhou Medical College
Guangzhou, Guangdong, China
Yuexiu area Hospital of TCM in Guangzhou
Guangzhou, Guangdong, China
Chinese medicine hospital in Liwan District of Guangzhou City
Guangzhou, Guangdong, China
Third Affiliated Hospital of Guangzhou Medical College
Guangzhou, Guangdong, China
Guangzhou Red Cross Hospital
Guangzhou, Guangdong, China
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China
Third Affiliated Hospital of Zhongshan University
Guangzhou, Guangdong, China
People's Hospital of Huizhou City Center
Huizhou, Guangdong, China
Huizhou People Hospital in Guangdong Province
Huizhou, Guangdong, China
Jiangmen Wuyi Chinese medicine hospital
Jiangmen, Guangdong, China
Chinese medicine hospital Conghua City
Jiekou, Guangdong, China
Chinese medicine hospital in Maoming City
Maoming, Guangdong, China
Shenzhen City People's Hospital
Shenzhen, Guangdong, China
Taishan Hospital of TCM in Guangdong Province
Taishan, Guangdong, China
Xinhui Hospital of TCM in Guangdong Province
Xinhui District, Guangdong, China
Yangjiang Hospital of TCM in Guangdong Province
Yangjiang, Guangdong, China
Xinxing Hospitla of TCM in Guangdong Province
Yunfu, Guangdong, China
Chinese medicine hospital in Zhongshan City, Guangdong Province
Zhongshan, Guangdong, China
Chinese medicine hospital in Zhuhai, Guangdong Province Hospital
Zhuhai, Guangdong, China
Liuzhou Hospital of TCM in Guangxi
Liuzhou, Guangxi, China
Ruikang Hospital Guangxi College of Traditional Chinese Medicine
Nanning, Guangxi, China
First Affiliated Hospital of Guangxi College of Traditional Chinese Medicine
Nanning, Guangxi, China
Guangxi Wuzhou Red Cross Hospital
Wuzhou, Guangxi, China
First Hospital of Handan City, Hebei Province
Handan, Hebei, China
The First Affiliated Hospital of Henan College of Traditional Chinese Medicine
Zhengzhou, Henan, China
Chinese medicine hospital in Zhengzhou City in Henan Province
Zhengzhou, Henan, China
Henan Province, the Third Affiliated Hospital of College of Traditional Chinese Medicine
Zhengzhou, Henan, China
Chinese medicine hospital in Hubei Province
Wuhan, Hubei, China
First Hospital of Wuhan City
Wuhan, Hubei, China
Wuhan University People's Hospital
Wuhan, Hubei, China
Xiangya Hospital Central South University
Changsha, Hunan, China
Hengyang Central Hospital
Hengyang, Hunan, China
The 169th Hospital of PLA
Hengyang, Hunan, China
Lianyungang Hospital of TCM in Jiangsu Province
Lianyungang, Jiangsu, China
Chinese medicine hospital in Jiangsu Province
Nanjing, Jiangsu, China
Jiangsu Provincial People's Hospital
Nanjing, Jiangsu, China
Affiliated Hospital of Nantong University
Nantong, Jiangxi, China
Liaoning University of Traditional Chinese Medicine Affiliated Hospital
Shenyang, Liaoning, China
Chinese Medicine Hospital of Jinan City
Jinan, Shandong, China
Subsidiary of Shanghai University of Traditional Chinese Medicine, Longhua Hospital
Shanghai, Shanghai Municipality, China
Pudong New Area People Hospital in Shanghai
Shanghai, Shanghai Municipality, China
Ankang Hospital of TCM in Shanxi Province
Ankang, Shanxi, China
Qishan Hospital in Shanxi Province
Qishan, Shanxi, China
The 2nd affiliated Hospital fo Shanxi college of TCM
Taiyuan, Shanxi, China
Affiliated Hospital of Shaanxi College of Traditional Chinese Medicine
Xianyang, Shanxi, China
Chinese medicine hospital in Xi'an
Xi’an, Shanxi, China
Xi'an Central Hospital
Xi’an, Shanxi, China
Shaanxi Provincial People's Hospital
Xi’an, Shanxi, China
The Second Affiliated Hospital of Xi'an Jiaotong University Medical College
Xi’an, Shanxi, China
Chengdu Integrated Hospital
Chengdu, Sichuan, China
The Affiliated Hospital of Chengdu University of Traditional Chinese Medicine
Chengdu, Sichuan, China
West China Hospital of Sichuan University
Chengdu, Sichuan, China
People's Hospital of Sichuan Province
Chengdu, Sichuan, China
The 2nd People Hospital of Chengdu City
Chengdu, Sichuan, China
Guangyuan Hospital of TCM in Sichuan Province
Guangyuan, Sichuan, China
Jianyang Hospital of TCM in Sichuang Province
Jiancheng, Sichuan, China
Leshan City People's Hospital
Leshan, Sichuan, China
Affiliated Hospital of Luzhou Medical College
Luzhou, Sichuan, China
The Affiliated Hospital of TCM of Luzhou Medical School
Luzhou, Sichuan, China
Mianyang Hospital of TCM in Sichuan Province
Mianyang, Sichuan, China
Affiliated Hospital of North Sichuan Medical College
Nanchong, Sichuan, China
Anyue Hospital of TCM in Sichuan Province
Yueyang, Sichuan, China
Wulumuqi Hospital of TCM
Ürümqi, Xinjiang, China
Xinjiang Medical University Affiliated Hospital of First Clinical
Ürümqi, Xinjiang, China
The First Affiliated Hospital of Zhejiang University of Traditional Chinese Medicine
Hangzhou, Zhejiang, China
Zhejiang University School of Medicine Second Affiliated Hospital
Hangzhou, Zhejiang, China
Chinese medicine hospital in Hangzhou
Hangzhou, Zhejiang, China
Ningbo City, Zhejiang Province zhongRui hospital
Ningbo, Zhejiang, China
Tiantan Hospital Capital University of Medical Sciences
Beijing, , China
The Second Affiliated Hospital of Chongqing Third Military Medical University
Chongqing, , China
Medical College of Shanghai Jiaotong University Yan Chai Hospital
Shanghai, , China
Shanghai Jiaotong University Medical College Ruijin Hospital
Shanghai, , China
Subsidiary of Shanghai University of Traditional Chinese Medicine ,Shuguang Hospital
Shanghai, , China
Countries
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Other Identifiers
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2006BAI04A02
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
2006BAI04A02
Identifier Type: -
Identifier Source: org_study_id