Overview

The Secondary Prevention Trial for Ischemic Stroke With DengzhanShengmai Capsule

Status:
Completed
Trial end date:
2011-01-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Guangzhou University of Traditional Chinese Medicine
Collaborators:
169 Military Hospital of China
Affiliated Hospital of Nantong University
Affiliated Hospital of North Sichuan Medical College
Anhui Provincial Hospital of Traditional Chinese Medicine
Ankang Hospital of Traditional Chinese Medicine
Anyue County Hospital of Traditional Chinese
Beijing Tiantan Hospital
Chengdu Integrated TCM&Western Medicine Hospital
Conghua city hospital of TCM
Dongguan city hospital of TCM
First Affiliated Hospital of Fujian Medical University
First Affiliated Hospital of Xinjiang Medical University
First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Foshan Hospital of Traditional Chinese Medicine
Guagnzhou Liwan district Hospital of TCM
Guagnzhou Red Cross Hospital
Guangdong Provincial Hospital of Traditional Chinese Medicine
Guangdong Second Provincial Traditional Chinese Medicine Hospital
Guangxi Ruikang Hospital
Guangyuan city hospital of TCM of Sichuan Province
Guangzhou Red Cross Hospital
Hangzhou City Hospital of TCM
Hubei General Hospital
Hubei Hospital of Traditional Chinese Medicine
Huizhou Municipal Central Hospital
Jiangmen Wuyi Traditional Chinese Medicine Hospital
Jiangsu province hospital of TCM
Jiangsu Provincial People's Hospital
Jinan city hospital of TCM
Lianyungang Chinese Medicine Hospital
Liuzhou City hospital of TCM
Longhua Hospital
Luzhou Medical College
Maoming city hospital of TCM
Mianyang city hospital of TCM
Nanfang Hospital of Southern Medical University
Nanhai Hospital of Traditional Chinese Medicine
Nantong University
People's hospital of Huizhou city
People's hospital of Jianyang city
People's Hospital of Leshan
Qishan county hospital of shaanxi province
Ruijin Hospital
Second Affiliated Hospital of Xi'an Jiaotong University
Second Affiliated Hospital, School of Medicine, Zhejiang University
Second Affiliated Hospital, Sun Yat-Sen University
Shaanxi Hospital of Traditional Chinese Medicine
Shaanxi Provincial People's Hospital
Shanghai Jiao Tong University School of Medicine
Shanghai Pudong New Area People's Hospital
Shenzhen People's Hospital
ShuGuang Hospital
Shunde district hospital of TCM
Southern branch of yuexiu district hospital of TCM
Suining People's Hospital
Taishan city hospital of TCM
Teaching Hospital of Chengdu University of TCM
The affiliated hospital of Liaoning University of Traditional Chinese Medicine
The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine
The First Affiliated Hospital of Guangxi University of Chinese Medicine
The First Affiliated Hospital of Guangzhou Medical University
The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
The First Hospital of Handan City
The First Teaching Hospital of Xinjiang Medical University
The People's Hospital of Leshan
The second affiliated hospital of shanxi college of TCM
The Second People's Hospital of Yibin
The Third Affiliated Hospital of Guangzhou Medical University
The Third Affiliated Hospital of Henan University of Traditional Chinese Medicine
The Third People's Hospital of Chengdu
Third Affiliated Hospital, Sun Yat-Sen University
URUMQI Hospital of Traditional Chinese Medicine
West China Hospital
Wuhan Interated &Western Hospital
Wuzhou city red cross hospital
Wuzhou Red Cross Hospital
Xi'an Central Hospital
Xi'an city hospital of TCM
Xiangya Hospital of Central South University
Xinhui hospital of TCM of Jiangmen
Xinxing county hospital of TCM
Yangjiang City Hospital of TCM in Guangdong Province
Yufu City Hospital of TCM in Guangdong Province
Zhejiang Provincial Hospital of TCM
Zhengzhou City Hospital of Traditional Chinese Medicine
Zhongshan Hospital Of Traditional Chinese Medicine
ZhuHai Hospital
Zongrui Hospital
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