Clinical trial NCT00548223: The Secondary Prevention Trial for Ischemic Stroke With DengzhanShengmai Capsule
Official title: Model Study on the Comprehensive Treating Protocol and Effect Evaluation of Ischemic Stroke With Traditional Chinese Medicine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Stroke
Keywords: recurrence of stroke
Dengzhan Shengmai Capsule
Traditional Chinese Medicine
Lead sponsor: Guangzhou University of Traditional Chinese Medicine
Sponsor class: OTHER
Collaborators: name: Second Affiliated Hospital, School of Medicine, Zhejiang University
name: Nanhai Hospital of Traditional Chinese Medicine
name: People's hospital of Huizhou city
name: Taishan city hospital of TCM
name: Ruijin Hospital
name: First Affiliated Hospital of Fujian Medical University
name: Yangjiang City Hospital of TCM in Guangdong Province
name: Xinxing county hospital of TCM
name: Southern branch of yuexiu district hospital of TCM
name: Xinhui hospital of TCM of Jiangmen
name: Shanghai Pudong New Area People's Hospital
name: People's hospital of Jianyang city
name: Luzhou Medical College
name: Mianyang city hospital of TCM
name: Guangyuan city hospital of TCM of Sichuan Province
name: The Third Affiliated Hospital of Guangzhou Medical University
name: Shunde district hospital of TCM
name: Shenzhen People's Hospital
name: Anyue County Hospital of Traditional Chinese
name: Chengdu Integrated TCM&Western Medicine Hospital
name: Guangzhou Red Cross Hospital
name: Jiangsu Provincial People's Hospital
name: Ankang Hospital of Traditional Chinese Medicine
name: Qishan county hospital of shaanxi province
name: Zongrui Hospital
name: First Affiliated Hospital of Xinjiang Medical University
name: Lianyungang Chinese Medicine Hospital
name: Yufu City Hospital of TCM in Guangdong Province
name: 169 Military Hospital of China
name: Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
name: The second affiliated hospital of shanxi college of TCM
name: URUMQI Hospital of Traditional Chinese Medicine
name: Hubei General Hospital
name: The People's Hospital of Leshan
name: Guagnzhou Liwan district Hospital of TCM
name: Longhua Hospital
name: Shanghai Jiao Tong University School of Medicine
name: Hangzhou City Hospital of TCM
name: Dongguan city hospital of TCM
name: Liuzhou City hospital of TCM
name: Maoming city hospital of TCM
name: Beijing Tiantan Hospital
name: Affiliated Hospital of Nantong University
name: Xi'an city hospital of TCM
name: Jiangsu province hospital of TCM
name: The Third People's Hospital of Chengdu
name: Huizhou Municipal Central Hospital
name: Zhejiang Provincial Hospital of TCM
name: The Second People's Hospital of Yibin
name: Shanxi Provincial People's Hospital
name: The First Affiliated Hospital of Guangzhou Medical University
name: Guangxi Ruikang Hospital
name: Third Affiliated Hospital, Sun Yat-Sen University
name: First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
name: Afﬁliated Hospital of North Sichuan Medical College
name: Third Affiliated Hospital of Henan University of Traditional Chinese Medicine
name: ZhuHai Hospital
name: Nanfang Hospital, Southern Medical University
name: West China Hospital
name: Guangdong Second Provincial Traditional Chinese Medicine Hospital
name: Handan First Hospital
name: The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine
name: Conghua city hospital of TCM
name: The First Affiliated Hospital of Guangxi University of Chinese Medicine
name: Hubei Hospital of Traditional Chinese Medicine
name: Jinan city hospital of TCM
name: Shaanxi Hospital of Traditional Chinese Medicine
name: Suining People's Hospital
name: Wuzhou Red Cross Hospital
name: Wuhan Interated ＆Western Hospital
name: Second Affiliated Hospital of Xi'an Jiaotong University
name: Xi'an Central Hospital
name: Zhengzhou City Hospital of Traditional Chinese Medicine
name: Xiangya Hospital of Central South University
name: Second Affiliated Hospital, Sun Yat-Sen University
name: The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
name: ShuGuang Hospital
name: Zhongshan Hospital Of Traditional Chinese Medicine
name: Foshan Hospital of Traditional Chinese Medicine
name: Teaching Hospital of Chengdu University of TCM
name: Jiangmen Wuyi Hospital of Traditional Chinese Medicine
name: Guangdong Provincial Hospital of Traditional Chinese Medicine
First posted: 2007-10-23
Enrollment: 3143
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: recurrence of stroke
timeFrame: 1 year
Secondary outcomes:
measure: incidence rate of cardiovascular events, and peripheral arterial events
timeFrame: 1 year
Other outcomes:
Locations:
city: Hefei
country: China
facility: Anhui College of Traditional Chinese Medicine First Affiliated Hospital
state: Anhui
city: Beijing
country: China
facility: Xuanwu Hospital of Capital University of Medical Sciences
state: Beijing
city: Fuzhou
country: China
facility: First Affiliated Hospital of Fujian Medical University
state: Fujian
city: Conghua
country: China
facility: Chinese medicine hospital Conghua City
state: Guangdong
city: Dongguan
country: China
facility: Dongguan City Chinese medicine hospital
state: Guangdong
city: Foshan
country: China
facility: Chinese medicine hospital in Foshan city
state: Guangdong
city: Foshan
country: China
facility: Foshan First People's Hospital
state: Guangdong
city: Foshan
country: China
facility: Integrated Hospital in Guangdong Province
state: Guangdong
city: Foshan
country: China
facility: Foshan Shunde Area Integrated Hospital in Guangdong Province
state: Guangdong
city: Guangzhou
country: China
facility: The second Chinese medicine hospital in Guangdong Province
state: Guangdong
city: Guangzhou
country: China
facility: Guangdong Province Hospital of Tradtional Chinese Medicine
state: Guangdong
city: Guangzhou
country: China
facility: Second Affiliated Hospital of Zhongshan University
state: Guangdong
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Guangzhou Medical College
state: Guangdong
city: Guangzhou
country: China
facility: Yuexiu area Hospital of TCM in Guangzhou
state: Guangdong
city: Guangzhou
country: China
facility: Chinese medicine hospital in Liwan District of Guangzhou City
state: Guangdong
city: Guangzhou
country: China
facility: Third Affiliated Hospital of Guangzhou Medical College
state: Guangdong
city: Guangzhou
country: China
facility: Guangzhou Red Cross Hospital
state: Guangdong
city: Guangzhou
country: China
facility: Nanfang Hospital, Southern Medical University
state: Guangdong
city: Guangzhou
country: China
facility: Third Affiliated Hospital of Zhongshan University
state: Guangdong
city: Huizhou
country: China
facility: People's Hospital of Huizhou City Center
state: Guangdong
city: Huizhou
country: China
facility: Huizhou People Hospital in Guangdong Province
state: Guangdong
city: Jiangmen
country: China
facility: Jiangmen Wuyi Chinese medicine hospital
state: Guangdong
city: Maoming
country: China
facility: Chinese medicine hospital in Maoming City
state: Guangdong
city: Shenzhen
country: China
facility: Shenzhen City People's Hospital
state: Guangdong
city: Taishan
country: China
facility: Taishan Hospital of TCM in Guangdong Province
state: Guangdong
city: Xinhui
country: China
facility: Xinhui Hospital of TCM in Guangdong Province
state: Guangdong
city: Yangjiang
country: China
facility: Yangjiang Hospital of TCM in Guangdong Province
state: Guangdong
city: Yunfu
country: China
facility: Xinxing Hospitla of TCM in Guangdong Province
state: Guangdong
city: Zhongshan
country: China
facility: Chinese medicine hospital in Zhongshan City, Guangdong Province
state: Guangdong
city: Zhuhai
country: China
facility: Chinese medicine hospital in Zhuhai, Guangdong Province Hospital
state: Guangdong
city: Liuzhou
country: China
facility: Liuzhou Hospital of TCM in Guangxi
state: Guangxi
city: Nanning
country: China
facility: Ruikang Hospital Guangxi College of Traditional Chinese Medicine
state: Guangxi
city: Nanning
country: China
facility: First Affiliated Hospital of Guangxi College of Traditional Chinese Medicine
state: Guangxi
city: Wuzhou
country: China
facility: Guangxi Wuzhou Red Cross Hospital
state: Guangxi
city: Handan
country: China
facility: First Hospital of Handan City, Hebei Province
state: Hebei
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Henan College of Traditional Chinese Medicine
state: Henan
city: Zhengzhou
country: China
facility: Chinese medicine hospital in Zhengzhou City in Henan Province
state: Henan
city: Zhengzhou
country: China
facility: Henan Province, the Third Affiliated Hospital of College of Traditional Chinese Medicine
state: Henan
city: Wuhan
country: China
facility: Chinese medicine hospital in Hubei Province
state: Hubei
city: Wuhan
country: China
facility: First Hospital of Wuhan City
state: Hubei
city: Wuhan
country: China
facility: Wuhan University People's Hospital
state: Hubei
city: Changsha
country: China
facility: Xiangya Hospital Central South University
state: Hunan
city: Hengyang
country: China
facility: Hengyang Central Hospital
state: Hunan
city: Hengyang
country: China
facility: The 169th Hospital of PLA
state: Hunan
city: Lianyungang
country: China
facility: Lianyungang Hospital of TCM in Jiangsu Province
state: Jiangsu
city: Nanjing
country: China
facility: Chinese medicine hospital in Jiangsu Province
state: Jiangsu
city: Nanjing
country: China
facility: Jiangsu Provincial People's Hospital
state: Jiangsu
city: Nantong
country: China
facility: Affiliated Hospital of Nantong University
state: Jiangxi
city: Shenyang
country: China
facility: Liaoning University of Traditional Chinese Medicine Affiliated Hospital
state: Liaoning
city: Jinan
country: China
facility: Chinese Medicine Hospital of Jinan City
state: Shandong
city: Shanghai
country: China
facility: Subsidiary of Shanghai University of Traditional Chinese Medicine, Longhua Hospital
state: Shanghai
city: Shanghai
country: China
facility: Pudong New Area People Hospital in Shanghai
state: Shanghai
city: Ankang
country: China
facility: Ankang Hospital of TCM in Shanxi Province
state: Shanxi
city: Qishan
country: China
facility: Qishan Hospital in Shanxi Province
state: Shanxi
city: Taiyuan
country: China
facility: The 2nd affiliated Hospital fo Shanxi college of TCM
state: Shanxi
city: Xi'an
country: China
facility: Chinese medicine hospital in Xi'an
state: Shanxi
city: Xi'an
country: China
facility: Xi'an Central Hospital
state: Shanxi
city: Xi'an
country: China
facility: Shaanxi Provincial People's Hospital
state: Shanxi
city: Xi'an
country: China
facility: The Second Affiliated Hospital of Xi'an Jiaotong University Medical College
state: Shanxi
city: Xianyang
country: China
facility: Affiliated Hospital of Shaanxi College of Traditional Chinese Medicine
state: Shanxi
city: Anyue
country: China
facility: Anyue Hospital of TCM in Sichuan Province
state: Sichuan
city: Chengdu
country: China
facility: Chengdu Integrated Hospital
state: Sichuan
city: Chengdu
country: China
facility: The Affiliated Hospital of Chengdu University of Traditional Chinese Medicine
state: Sichuan
city: Chengdu
country: China
facility: West China Hospital of Sichuan University
state: Sichuan
city: Chengdu
country: China
facility: People's Hospital of Sichuan Province
state: Sichuan
city: Chengdu
country: China
facility: The 2nd People Hospital of Chengdu City
state: Sichuan
city: Guangyuan
country: China
facility: Guangyuan Hospital of TCM in Sichuan Province
state: Sichuan
city: Jianyang
country: China
facility: Jianyang Hospital of TCM in Sichuang Province
state: Sichuan
city: Leshan
country: China
facility: Leshan City People's Hospital
state: Sichuan
city: Luzhou
country: China
facility: Affiliated Hospital of Luzhou Medical College
state: Sichuan
city: Luzhou
country: China
facility: The Affiliated Hospital of TCM of Luzhou Medical School
state: Sichuan
city: Mianyang
country: China
facility: Mianyang Hospital of TCM in Sichuan Province
state: Sichuan
city: Nanchong
country: China
facility: Affiliated Hospital of North Sichuan Medical College
state: Sichuan
city: Wulumuqi
country: China
facility: Wulumuqi Hospital of TCM
state: Xinjiang
city: Wulumuqi
country: China
facility: Xinjiang Medical University Affiliated Hospital of First Clinical
state: Xinjiang
city: Hangzhou
country: China
facility: The First Affiliated Hospital of Zhejiang University of Traditional Chinese Medicine
state: Zhejiang
city: Hangzhou
country: China
facility: Zhejiang University School of Medicine Second Affiliated Hospital
state: Zhejiang
city: Hangzhou
country: China
facility: Chinese medicine hospital in Hangzhou
state: Zhejiang
city: Ningbo
country: China
facility: Ningbo City, Zhejiang Province zhongRui hospital
state: Zhejiang
city: Beijing
country: China
facility: Tiantan Hospital Capital University of Medical Sciences
city: Chongqing
country: China
facility: The Second Affiliated Hospital of Chongqing Third Military Medical University
city: Shanghai
country: China
facility: Medical College of Shanghai Jiaotong University Yan Chai Hospital
city: Shanghai
country: China
facility: Shanghai Jiaotong University Medical College Ruijin Hospital
city: Shanghai
country: China
facility: Subsidiary of Shanghai University of Traditional Chinese Medicine ,Shuguang Hospital
Study officials:
affiliation: Guangdong Provincial Hospital of Tradtional Chinese Medicine
name: Yan Huang, Bachelor
role: PRINCIPAL_INVESTIGATOR
References: