The Secondary Prevention Trial for Ischemic Stroke With DengzhanShengmai Capsule

Stroke Clinical Trial

— SPIRITDZSM1  

Official title:

Model Study on the Comprehensive Treating Protocol and Effect Evaluation of Ischemic Stroke With Traditional Chinese Medicine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00548223
• Other study ID #: 2006BAI04A02
• Secondary ID: 2006BAI04A02
• Status: Completed
• Phase: Phase 4
• First received: October 11, 2007
• Last updated: August 5, 2013
• Start date: December 2007
• Est. completion date: January 2011

Study information

• Verified date: August 2013
• Source: Guangzhou University of Traditional Chinese Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: The China Academy of Chinese Medical SciencesChina: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 3143
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Stroke

Intervention

Drug:
• Dengzhan Shengmai capsule
Capsule, 0.18g, 2#, Bid*1year
• placebo
Capsule, 0.18g, 2#, Bid*1year

Locations

Country	Name	City	State
China	Ankang Hospital of TCM in Shanxi Province	Ankang	Shanxi
China	Anyue Hospital of TCM in Sichuan Province	Anyue	Sichuan
China	Tiantan Hospital Capital University of Medical Sciences	Beijing
China	Xuanwu Hospital of Capital University of Medical Sciences	Beijing	Beijing
China	Xiangya Hospital Central South University	Changsha	Hunan
China	Chengdu Integrated Hospital	Chengdu	Sichuan
China	People's Hospital of Sichuan Province	Chengdu	Sichuan
China	The 2nd People Hospital of Chengdu City	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	The Second Affiliated Hospital of Chongqing Third Military Medical University	Chongqing
China	Chinese medicine hospital Conghua City	Conghua	Guangdong
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	Foshan Shunde Area Integrated Hospital in Guangdong Province	Foshan	Guangdong
China	Integrated Hospital in Guangdong Province	Foshan	Guangdong
China	First Affiliated Hospital of Fujian Medical University	Fuzhou	Fujian
China	Guangyuan Hospital of TCM in Sichuan Province	Guangyuan	Sichuan
China	Chinese medicine hospital in Liwan District of Guangzhou City	Guangzhou	Guangdong
China	Guangdong Province Hospital of Tradtional Chinese Medicine	Guangzhou	Guangdong
China	Guangzhou Red Cross Hospital	Guangzhou	Guangdong
China	Nanfang Hospital, Southern Medical University	Guangzhou	Guangdong
China	Second Affiliated Hospital of Zhongshan University	Guangzhou	Guangdong
China	The First Affiliated Hospital of Guangzhou Medical College	Guangzhou	Guangdong
China	The second Chinese medicine hospital in Guangdong Province	Guangzhou	Guangdong
China	Third Affiliated Hospital of Guangzhou Medical College	Guangzhou	Guangdong
China	Third Affiliated Hospital of Zhongshan University	Guangzhou	Guangdong
China	Yuexiu area Hospital of TCM in Guangzhou	Guangzhou	Guangdong
China	First Hospital of Handan City, Hebei Province	Handan	Hebei
China	Chinese medicine hospital in Hangzhou	Hangzhou	Zhejiang
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	Anhui College of Traditional Chinese Medicine First Affiliated Hospital	Hefei	Anhui
China	Hengyang Central Hospital	Hengyang	Hunan
China	The 169th Hospital of PLA	Hengyang	Hunan
China	Huizhou People Hospital in Guangdong Province	Huizhou	Guangdong
China	People's Hospital of Huizhou City Center	Huizhou	Guangdong
China	Jiangmen Wuyi Chinese medicine hospital	Jiangmen	Guangdong
China	Jianyang Hospital of TCM in Sichuang Province	Jianyang	Sichuan
China	Chinese Medicine Hospital of Jinan City	Jinan	Shandong
China	Leshan City People's Hospital	Leshan	Sichuan
China	Lianyungang Hospital of TCM in Jiangsu Province	Lianyungang	Jiangsu
China	Liuzhou Hospital of TCM in Guangxi	Liuzhou	Guangxi
China	Affiliated Hospital of Luzhou Medical College	Luzhou	Sichuan
China	The Affiliated Hospital of TCM of Luzhou Medical School	Luzhou	Sichuan
China	Chinese medicine hospital in Maoming City	Maoming	Guangdong
China	Mianyang Hospital of TCM in Sichuan Province	Mianyang	Sichuan
China	Affiliated Hospital of North Sichuan Medical College	Nanchong	Sichuan
China	Chinese medicine hospital in Jiangsu Province	Nanjing	Jiangsu
China	Jiangsu Provincial People's Hospital	Nanjing	Jiangsu
China	First Affiliated Hospital of Guangxi College of Traditional Chinese Medicine	Nanning	Guangxi
China	Ruikang Hospital Guangxi College of Traditional Chinese Medicine	Nanning	Guangxi
China	Affiliated Hospital of Nantong University	Nantong	Jiangxi
China	Ningbo City, Zhejiang Province zhongRui hospital	Ningbo	Zhejiang
China	Qishan Hospital in Shanxi Province	Qishan	Shanxi
China	Medical College of Shanghai Jiaotong University Yan Chai Hospital	Shanghai
China	Pudong New Area People Hospital in Shanghai	Shanghai	Shanghai
China	Shanghai Jiaotong University Medical College Ruijin Hospital	Shanghai
China	Subsidiary of Shanghai University of Traditional Chinese Medicine ,Shuguang Hospital	Shanghai
China	Subsidiary of Shanghai University of Traditional Chinese Medicine, Longhua Hospital	Shanghai	Shanghai
China	Liaoning University of Traditional Chinese Medicine Affiliated Hospital	Shenyang	Liaoning
China	Shenzhen City People's Hospital	Shenzhen	Guangdong
China	Taishan Hospital of TCM in Guangdong Province	Taishan	Guangdong
China	The 2nd affiliated Hospital fo Shanxi college of TCM	Taiyuan	Shanxi
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	Wulumuqi Hospital of TCM	Wulumuqi	Xinjiang
China	Xinjiang Medical University Affiliated Hospital of First Clinical	Wulumuqi	Xinjiang
China	Guangxi Wuzhou Red Cross Hospital	Wuzhou	Guangxi
China	Chinese medicine hospital in Xi'an	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	Xi'an Central Hospital	Xi'an	Shanxi
China	Affiliated Hospital of Shaanxi College of Traditional Chinese Medicine	Xianyang	Shanxi
China	Xinhui Hospital of TCM in Guangdong Province	Xinhui	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 Zhengzhou City in Henan Province	Zhengzhou	Henan
China	Henan Province, the Third Affiliated Hospital of College of Traditional Chinese Medicine	Zhengzhou	Henan
China	The First Affiliated Hospital of Henan College of Traditional Chinese Medicine	Zhengzhou	Henan
China	Chinese medicine hospital in Zhongshan City, Guangdong Province	Zhongshan	Guangdong
China	Chinese medicine hospital in Zhuhai, Guangdong Province Hospital	Zhuhai	Guangdong

Sponsors (83)

Lead Sponsor

Collaborator

Guangzhou University of Traditional Chinese Medicine

169 Military Hospital of China, Af?liated 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 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, Guangxi Ruikang Hospital, Guangyuan city hospital of TCM of Sichuan Province, Hangzhou City Hospital of TCM, Hubei General Hospital, Hubei Provincial Hospital of TCM, 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 Chengdu Third People's Hospital, 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 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, Third Affiliated Hospital, Sun Yat-Sen University, URUMQI Hospital of Traditional Chinese Medicine, West China School of Medicine West China Hospital,Sichuan University, Wuhan Interated &Western Hospital, Wuzhou city red cross hospital, Xi'an city 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

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	recurrence of stroke		1 year	Yes
Secondary	incidence rate of cardiovascular events, and peripheral arterial events		1 year	Yes