The Secondary Prevention Trial for Ischemic Stroke With DengzhanShengmai Capsule
SPIRITDZSM1
Model Study on the Comprehensive Treating Protocol and Effect Evaluation of Ischemic Stroke With Traditional Chinese Medicine
1 other identifier
interventional
3,143
1 country
84
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 stroke
Started Dec 2007
Typical duration for phase_4 stroke
84 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 11, 2007
CompletedFirst Posted
Study publicly available on registry
October 23, 2007
CompletedStudy Start
First participant enrolled
December 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2011
CompletedAugust 7, 2013
August 1, 2013
3.1 years
October 11, 2007
August 5, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
recurrence of stroke
1 year
Secondary Outcomes (1)
incidence rate of cardiovascular events, and peripheral arterial events
1 year
Study Arms (2)
Dengzhan Shengmai capsule
EXPERIMENTALDengzhan Shengmai capsule 0.18g by mouth twice a day for 1year
Placebo
PLACEBO COMPARATORPlacebo 0.18g by mouth twice a day for 1year
Interventions
Capsule, 0.18g, 2#, Bid\*1year
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Guangzhou University of Traditional Chinese Medicinelead
- Second Affiliated Hospital, School of Medicine, Zhejiang Universitycollaborator
- Nanhai Hospital of Traditional Chinese Medicinecollaborator
- People's hospital of Huizhou citycollaborator
- Taishan city hospital of TCMcollaborator
- Ruijin Hospitalcollaborator
- First Affiliated Hospital of Fujian Medical Universitycollaborator
- Yangjiang City Hospital of TCM in Guangdong Provincecollaborator
- Xinxing county hospital of TCMcollaborator
- Southern branch of yuexiu district hospital of TCMcollaborator
- Xinhui hospital of TCM of Jiangmencollaborator
- Shanghai Pudong New Area People's Hospitalcollaborator
- People's hospital of Jianyang citycollaborator
- Luzhou Medical Collegecollaborator
- Mianyang city hospital of TCMcollaborator
- Guangyuan city hospital of TCM of Sichuan Provincecollaborator
- The Third Affiliated Hospital of Guangzhou Medical Universitycollaborator
- Shunde district hospital of TCMcollaborator
- Shenzhen People's Hospitalcollaborator
- Anyue County Hospital of Traditional Chinesecollaborator
- Chengdu Integrated TCM&Western Medicine Hospitalcollaborator
- Guangzhou Red Cross Hospitalcollaborator
- Jiangsu Provincial People's Hospitalcollaborator
- Ankang Hospital of Traditional Chinese Medicinecollaborator
- Qishan county hospital of shaanxi provincecollaborator
- Zongrui Hospitalcollaborator
- First Affiliated Hospital of Xinjiang Medical Universitycollaborator
- Lianyungang Chinese Medicine Hospitalcollaborator
- Yufu City Hospital of TCM in Guangdong Provincecollaborator
- 169 Military Hospital of Chinacollaborator
- Affiliated Hospital of Liaoning University of Traditional Chinese Medicinecollaborator
- The second affiliated hospital of shanxi college of TCMcollaborator
- URUMQI Hospital of Traditional Chinese Medicinecollaborator
- Hubei General Hospitalcollaborator
- The People's Hospital of Leshancollaborator
- Guagnzhou Liwan district Hospital of TCMcollaborator
- Longhua Hospitalcollaborator
- Shanghai Jiao Tong University School of Medicinecollaborator
- Hangzhou City Hospital of TCMcollaborator
- Dongguan city hospital of TCMcollaborator
- Liuzhou City hospital of TCMcollaborator
- Maoming city hospital of TCMcollaborator
- Beijing Tiantan Hospitalcollaborator
- Affiliated Hospital of Nantong Universitycollaborator
- Xi'an city hospital of TCMcollaborator
- Jiangsu province hospital of TCMcollaborator
- The Third People's Hospital of Chengducollaborator
- Huizhou Municipal Central Hospitalcollaborator
- Zhejiang Provincial Hospital of TCMcollaborator
- The Second People's Hospital of Yibincollaborator
- Shanxi Provincial People's Hospitalcollaborator
- The First Affiliated Hospital of Guangzhou Medical Universitycollaborator
- Guangxi Ruikang Hospitalcollaborator
- Third Affiliated Hospital, Sun Yat-Sen Universitycollaborator
- First Teaching Hospital of Tianjin University of Traditional Chinese Medicinecollaborator
- Affiliated Hospital of North Sichuan Medical Collegecollaborator
- Third Affiliated Hospital of Henan University of Traditional Chinese Medicinecollaborator
- ZhuHai Hospitalcollaborator
- Nanfang Hospital, Southern Medical Universitycollaborator
- West China Hospitalcollaborator
- Guangdong Second Provincial Traditional Chinese Medicine Hospitalcollaborator
- Handan First Hospitalcollaborator
- The First Affiliated Hospital of Anhui University of Traditional Chinese Medicinecollaborator
- Conghua city hospital of TCMcollaborator
- The First Affiliated Hospital of Guangxi University of Chinese Medicinecollaborator
- Hubei Hospital of Traditional Chinese Medicinecollaborator
- Jinan city hospital of TCMcollaborator
- Shaanxi Hospital of Traditional Chinese Medicinecollaborator
- Suining People's Hospitalcollaborator
- Wuzhou Red Cross Hospitalcollaborator
- Wuhan Interated ＆Western Hospitalcollaborator
- Second Affiliated Hospital of Xi'an Jiaotong Universitycollaborator
- Xi'an Central Hospitalcollaborator
- Zhengzhou City Hospital of Traditional Chinese Medicinecollaborator
- Xiangya Hospital of Central South Universitycollaborator
- Second Affiliated Hospital, Sun Yat-Sen Universitycollaborator
- The First Affiliated Hospital of Henan University of Traditional Chinese Medicinecollaborator
- ShuGuang Hospitalcollaborator
- Zhongshan Hospital Of Traditional Chinese Medicinecollaborator
- Foshan Hospital of Traditional Chinese Medicinecollaborator
- Teaching Hospital of Chengdu University of TCMcollaborator
- Jiangmen Wuyi Hospital of Traditional Chinese Medicinecollaborator
- Guangdong Provincial Hospital of Traditional Chinese Medicinecollaborator
Study Sites (84)
Anhui College of Traditional Chinese Medicine First Affiliated Hospital
Hefei, Anhui, 230031, China
Xuanwu Hospital of Capital University of Medical Sciences
Beijing, Beijing Municipality, 10053, China
First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, 350005, China
Dongguan City Chinese medicine hospital
Dongguan, Guangdong, 523005, China
Chinese medicine hospital in Foshan city
Foshan, Guangdong, 528000, China
Foshan First People's Hospital
Foshan, Guangdong, 528000, China
Integrated Hospital in Guangdong Province
Foshan, Guangdong, 528200, China
Foshan Shunde Area Integrated Hospital in Guangdong Province
Foshan, Guangdong, 528333, China
The second Chinese medicine hospital in Guangdong Province
Guangzhou, Guangdong, 510095, China
Guangdong Province Hospital of Tradtional Chinese Medicine
Guangzhou, Guangdong, 510120, China
Second Affiliated Hospital of Zhongshan University
Guangzhou, Guangdong, 510120, China
The First Affiliated Hospital of Guangzhou Medical College
Guangzhou, Guangdong, 510120, China
Yuexiu area Hospital of TCM in Guangzhou
Guangzhou, Guangdong, 510120, China
Chinese medicine hospital in Liwan District of Guangzhou City
Guangzhou, Guangdong, 510140, China
Third Affiliated Hospital of Guangzhou Medical College
Guangzhou, Guangdong, 510150, China
Guangzhou Red Cross Hospital
Guangzhou, Guangdong, 510220, China
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, 510515, China
Third Affiliated Hospital of Zhongshan University
Guangzhou, Guangdong, 510630, China
People's Hospital of Huizhou City Center
Huizhou, Guangdong, 516001, China
Huizhou People Hospital in Guangdong Province
Huizhou, Guangdong, 516002, China
Jiangmen Wuyi Chinese medicine hospital
Jiangmen, Guangdong, 529000, China
Chinese medicine hospital Conghua City
Jiekou, Guangdong, 5109000, China
Chinese medicine hospital in Maoming City
Maoming, Guangdong, 525000, China
Shenzhen City People's Hospital
Shenzhen, Guangdong, China
Taishan Hospital of TCM in Guangdong Province
Taishan, Guangdong, 529200, China
Xinhui Hospital of TCM in Guangdong Province
Xinhui District, Guangdong, 529100, China
Yangjiang Hospital of TCM in Guangdong Province
Yangjiang, Guangdong, 529500, China
Xinxing Hospitla of TCM in Guangdong Province
Yunfu, Guangdong, 527400, China
Chinese medicine hospital in Zhongshan City, Guangdong Province
Zhongshan, Guangdong, 528400, China
Chinese medicine hospital in Zhuhai, Guangdong Province Hospital
Zhuhai, Guangdong, 519015, China
Liuzhou Hospital of TCM in Guangxi
Liuchow, Guangxi, 545001, China
Ruikang Hospital Guangxi College of Traditional Chinese Medicine
Nanning, Guangxi, 530011, China
First Affiliated Hospital of Guangxi College of Traditional Chinese Medicine
Nanning, Guangxi, 530023, China
Guangxi Wuzhou Red Cross Hospital
Wuzhou, Guangxi, 543002, China
First Hospital of Handan City, Hebei Province
Handan, Hebei, 56002, China
The First Affiliated Hospital of Henan College of Traditional Chinese Medicine
Zhengzhou, Henan, 450000, China
Chinese medicine hospital in Zhengzhou City in Henan Province
Zhengzhou, Henan, 450007, China
Henan Province, the Third Affiliated Hospital of College of Traditional Chinese Medicine
Zhengzhou, Henan, 450008, China
Chinese medicine hospital in Hubei Province
Wuhan, Hubei, 430006, China
First Hospital of Wuhan City
Wuhan, Hubei, 430022, China
Wuhan University People's Hospital
Wuhan, Hubei, 430060, China
Xiangya Hospital Central South University
Changsha, Hunan, 410008, China
Hengyang Central Hospital
Hengyang, Hunan, 421001, China
The 169th Hospital of PLA
Hengyang, Hunan, 421002, China
Lianyungang Hospital of TCM in Jiangsu Province
Lianyungang, Jiangsu, 222004, China
Chinese medicine hospital in Jiangsu Province
Nanjing, Jiangsu, 210029, China
Jiangsu Provincial People's Hospital
Nanjing, Jiangsu, 210029, China
Affiliated Hospital of Nantong University
Nantong, Jiangxi, 226001, China
Liaoning University of Traditional Chinese Medicine Affiliated Hospital
Shenyang, Liaoning, 110032, China
Chinese Medicine Hospital of Jinan City
Jinan, Shandong, 250011, China
Subsidiary of Shanghai University of Traditional Chinese Medicine, Longhua Hospital
Shanghai, Shanghai Municipality, 200032, China
Pudong New Area People Hospital in Shanghai
Shanghai, Shanghai Municipality, 201200, China
Ankang Hospital of TCM in Shanxi Province
Ankang, Shanxi, 725000, China
Qishan Hospital in Shanxi Province
Qishan, Shanxi, 722400, China
The 2nd affiliated Hospital fo Shanxi college of TCM
Taiyuan, Shanxi, 030024, China
Affiliated Hospital of Shaanxi College of Traditional Chinese Medicine
Xianyang, Shanxi, 712000, China
Chinese medicine hospital in Xi'an
Xi’an, Shanxi, 710001, China
Xi'an Central Hospital
Xi’an, Shanxi, 710001, China
Shaanxi Provincial People's Hospital
Xi’an, Shanxi, 710068, China
The Second Affiliated Hospital of Xi'an Jiaotong University Medical College
Xi’an, Shanxi, China
Chengdu Integrated Hospital
Chengdu, Sichuan, 610016, China
The Affiliated Hospital of Chengdu University of Traditional Chinese Medicine
Chengdu, Sichuan, 610036, China
West China Hospital of Sichuan University
Chengdu, Sichuan, 610041, China
People's Hospital of Sichuan Province
Chengdu, Sichuan, 610072, China
The 2nd People Hospital of Chengdu City
Chengdu, Sichuan, 621000, China
Guangyuan Hospital of TCM in Sichuan Province
Guangyuan, Sichuan, 628000, China
Jianyang Hospital of TCM in Sichuang Province
Jiancheng, Sichuan, 641400, China
Leshan City People's Hospital
Leshan, Sichuan, 614000, China
Affiliated Hospital of Luzhou Medical College
Luzhou, Sichuan, 646000, China
The Affiliated Hospital of TCM of Luzhou Medical School
Luzhou, Sichuan, 646000, China
Mianyang Hospital of TCM in Sichuan Province
Mianyang, Sichuan, 621000, China
Affiliated Hospital of North Sichuan Medical College
Nanchong, Sichuan, 637000, China
Anyue Hospital of TCM in Sichuan Province
Yueyang, Sichuan, 642350, China
Wulumuqi Hospital of TCM
Ürümqi, Xinjiang, 830000, China
Xinjiang Medical University Affiliated Hospital of First Clinical
Ürümqi, Xinjiang, 830054, China
The First Affiliated Hospital of Zhejiang University of Traditional Chinese Medicine
Hangzhou, Zhejiang, 310006, China
Zhejiang University School of Medicine Second Affiliated Hospital
Hangzhou, Zhejiang, 313000, China
Chinese medicine hospital in Hangzhou
Hangzhou, Zhejiang, China
Ningbo City, Zhejiang Province zhongRui hospital
Ningbo, Zhejiang, 315806, China
Tiantan Hospital Capital University of Medical Sciences
Beijing, 100050, China
The Second Affiliated Hospital of Chongqing Third Military Medical University
Chongqing, 400037, China
Medical College of Shanghai Jiaotong University Yan Chai Hospital
Shanghai, 200001, China
Shanghai Jiaotong University Medical College Ruijin Hospital
Shanghai, 200025, China
Subsidiary of Shanghai University of Traditional Chinese Medicine ,Shuguang Hospital
Shanghai, 200032, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yan Huang, Bachelor
Guangdong Provincial Hospital of Tradtional Chinese Medicine
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
October 11, 2007
First Posted
October 23, 2007
Study Start
December 1, 2007
Primary Completion
January 1, 2011
Study Completion
January 1, 2011
Last Updated
August 7, 2013
Record last verified: 2013-08