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