The Secondary Prevention Trial for Ischemic Stroke With DengzhanShengmai Capsule (SPIRITDZSM1)
August 5, 2013 updated by: jianwen guo, MD, Guangzhou University of Traditional Chinese Medicine
Model Study on the Comprehensive Treating Protocol and Effect Evaluation of Ischemic Stroke With Traditional Chinese Medicine
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
3143
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Beijing, China, 100050
- Tiantan Hospital Capital University of Medical Sciences
-
Chongqing, China, 400037
- The Second Affiliated Hospital of Chongqing Third Military Medical University
-
Shanghai, China, 200001
- Medical College of Shanghai Jiaotong University Yan Chai Hospital
-
Shanghai, China, 200025
- Shanghai Jiaotong University Medical College Ruijin Hospital
-
Shanghai, China, 200032
- Subsidiary of Shanghai University of Traditional Chinese Medicine ,Shuguang Hospital
-
-
Anhui
-
Hefei, Anhui, China, 230031
- Anhui College of Traditional Chinese Medicine First Affiliated Hospital
-
-
Beijing
-
Beijing, Beijing, China, 10053
- Xuanwu Hospital of Capital University of Medical Sciences
-
-
Fujian
-
Fuzhou, Fujian, China, 350005
- First Affiliated Hospital of Fujian Medical University
-
-
Guangdong
-
Conghua, Guangdong, China, 5109000
- Chinese medicine hospital Conghua City
-
Dongguan, Guangdong, China, 523005
- Dongguan City Chinese medicine hospital
-
Foshan, Guangdong, China, 528000
- Foshan First People's Hospital
-
Foshan, Guangdong, China, 528000
- Chinese medicine hospital in Foshan city
-
Foshan, Guangdong, China, 528200
- Integrated Hospital in Guangdong Province
-
Foshan, Guangdong, China, 528333
- Foshan Shunde Area Integrated Hospital in Guangdong Province
-
Guangzhou, Guangdong, China, 510120
- Second Affiliated Hospital of Zhongshan University
-
Guangzhou, Guangdong, China, 510515
- Nanfang Hospital, Southern Medical University
-
Guangzhou, Guangdong, China, 510220
- Guangzhou red cross hospital
-
Guangzhou, Guangdong, China, 510120
- The First Affiliated Hospital of Guangzhou Medical College
-
Guangzhou, Guangdong, China, 510095
- The second Chinese medicine hospital in Guangdong Province
-
Guangzhou, Guangdong, China, 510120
- Guangdong Province Hospital of Tradtional Chinese Medicine
-
Guangzhou, Guangdong, China, 510120
- Yuexiu area Hospital of TCM in Guangzhou
-
Guangzhou, Guangdong, China, 510140
- Chinese medicine hospital in Liwan District of Guangzhou City
-
Guangzhou, Guangdong, China, 510150
- Third Affiliated Hospital of Guangzhou Medical College
-
Guangzhou, Guangdong, China, 510630
- Third Affiliated Hospital of Zhongshan University
-
Huizhou, Guangdong, China, 516001
- People's Hospital of Huizhou City Center
-
Huizhou, Guangdong, China, 516002
- Huizhou People Hospital in Guangdong Province
-
Jiangmen, Guangdong, China, 529000
- Jiangmen Wuyi Chinese medicine hospital
-
Maoming, Guangdong, China, 525000
- Chinese medicine hospital in Maoming City
-
Shenzhen, Guangdong, China
- Shenzhen city people's hospital
-
Taishan, Guangdong, China, 529200
- Taishan Hospital of TCM in Guangdong Province
-
Xinhui, Guangdong, China, 529100
- Xinhui Hospital of TCM in Guangdong Province
-
Yangjiang, Guangdong, China, 529500
- Yangjiang Hospital of TCM in Guangdong Province
-
Yunfu, Guangdong, China, 527400
- Xinxing Hospitla of TCM in Guangdong Province
-
Zhongshan, Guangdong, China, 528400
- Chinese medicine hospital in Zhongshan City, Guangdong Province
-
Zhuhai, Guangdong, China, 519015
- Chinese medicine hospital in Zhuhai, Guangdong Province Hospital
-
-
Guangxi
-
Liuzhou, Guangxi, China, 545001
- Liuzhou Hospital of TCM in Guangxi
-
Nanning, Guangxi, China, 530011
- Ruikang Hospital Guangxi College of Traditional Chinese Medicine
-
Nanning, Guangxi, China, 530023
- First Affiliated Hospital of Guangxi College of Traditional Chinese Medicine
-
Wuzhou, Guangxi, China, 543002
- Guangxi Wuzhou Red Cross Hospital
-
-
Hebei
-
Handan, Hebei, China, 56002
- First Hospital of Handan City, Hebei Province
-
-
Henan
-
Zhengzhou, Henan, China, 450000
- The First Affiliated Hospital of Henan College of Traditional Chinese Medicine
-
Zhengzhou, Henan, China, 450007
- Chinese medicine hospital in Zhengzhou City in Henan Province
-
Zhengzhou, Henan, China, 450008
- Henan Province, the Third Affiliated Hospital of College of Traditional Chinese Medicine
-
-
Hubei
-
Wuhan, Hubei, China, 430060
- Wuhan University People's Hospital
-
Wuhan, Hubei, China, 430006
- Chinese medicine hospital in Hubei Province
-
Wuhan, Hubei, China, 430022
- First Hospital of Wuhan City
-
-
Hunan
-
Changsha, Hunan, China, 410008
- Xiangya Hospital Central South University
-
Hengyang, Hunan, China, 421001
- Hengyang Central Hospital
-
Hengyang, Hunan, China, 421002
- The 169th Hospital of PLA
-
-
Jiangsu
-
Lianyungang, Jiangsu, China, 222004
- Lianyungang Hospital of TCM in Jiangsu Province
-
Nanjing, Jiangsu, China, 210029
- Jiangsu Provincial People's Hospital
-
Nanjing, Jiangsu, China, 210029
- Chinese medicine hospital in Jiangsu Province
-
-
Jiangxi
-
Nantong, Jiangxi, China, 226001
- Affiliated Hospital Of Nantong University
-
-
Liaoning
-
Shenyang, Liaoning, China, 110032
- Liaoning University of Traditional Chinese Medicine Affiliated Hospital
-
-
Shandong
-
Jinan, Shandong, China, 250011
- Chinese Medicine Hospital of Jinan City
-
-
Shanghai
-
Shanghai, Shanghai, China, 200032
- Subsidiary of Shanghai University of Traditional Chinese Medicine, Longhua Hospital
-
Shanghai, Shanghai, China, 201200
- Pudong New Area People Hospital in Shanghai
-
-
Shanxi
-
Ankang, Shanxi, China, 725000
- Ankang Hospital of TCM in Shanxi Province
-
Qishan, Shanxi, China, 722400
- Qishan Hospital in Shanxi Province
-
Taiyuan, Shanxi, China, 030024
- The 2nd affiliated Hospital fo Shanxi college of TCM
-
Xi'an, Shanxi, China, 710068
- Shaanxi Provincial People's Hospital
-
Xi'an, Shanxi, China, 710001
- Chinese medicine hospital in Xi'an
-
Xi'an, Shanxi, China, 710001
- Xi'an Central Hospital
-
Xi'an, Shanxi, China
- The Second Affiliated Hospital of Xi'an Jiaotong University Medical College
-
Xianyang, Shanxi, China, 712000
- Affiliated Hospital of Shaanxi College of Traditional Chinese Medicine
-
-
Sichuan
-
Anyue, Sichuan, China, 642350
- Anyue Hospital of TCM in Sichuan Province
-
Chengdu, Sichuan, China, 610041
- West China Hospital of Sichuan University
-
Chengdu, Sichuan, China, 610072
- People's Hospital of Sichuan Province
-
Chengdu, Sichuan, China, 610016
- Chengdu Integrated Hospital
-
Chengdu, Sichuan, China, 610036
- The Affiliated Hospital of Chengdu University of Traditional Chinese Medicine
-
Chengdu, Sichuan, China, 621000
- The 2nd People Hospital of Chengdu City
-
Guangyuan, Sichuan, China, 628000
- Guangyuan Hospital of TCM in Sichuan Province
-
Jianyang, Sichuan, China, 641400
- Jianyang Hospital of TCM in Sichuang Province
-
Leshan, Sichuan, China, 614000
- Leshan City People's Hospital
-
Luzhou, Sichuan, China, 646000
- Affiliated Hospital of Luzhou Medical College
-
Luzhou, Sichuan, China, 646000
- The Affiliated Hospital of TCM of Luzhou Medical School
-
Mianyang, Sichuan, China, 621000
- Mianyang Hospital of TCM in Sichuan Province
-
Nanchong, Sichuan, China, 637000
- Affiliated Hospital of North Sichuan Medical College
-
-
Xinjiang
-
Wulumuqi, Xinjiang, China, 830000
- Wulumuqi Hospital of TCM
-
Wulumuqi, Xinjiang, China, 830054
- Xinjiang Medical University Affiliated Hospital of First Clinical
-
-
Zhejiang
-
Hangzhou, Zhejiang, China, 310006
- The First Affiliated Hospital of Zhejiang University of Traditional Chinese Medicine
-
Hangzhou, Zhejiang, China, 313000
- Zhejiang University School of Medicine Second Affiliated Hospital
-
Hangzhou, Zhejiang, China
- Chinese medicine hospital in Hangzhou
-
Ningbo, Zhejiang, China, 315806
- Ningbo City, Zhejiang Province zhongRui hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 75 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Dengzhan Shengmai capsule
Dengzhan Shengmai capsule 0.18g by mouth twice a day for 1year
|
Capsule, 0.18g, 2#, Bid*1year
Other Names:
|
|
PLACEBO_COMPARATOR: Placebo
Placebo 0.18g by mouth twice a day for 1year
|
Capsule, 0.18g, 2#, Bid*1year
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
recurrence of stroke
Time Frame: 1 year
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
incidence rate of cardiovascular events, and peripheral arterial events
Time Frame: 1 year
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Yan Huang, Bachelor, Guangdong Provincial Hospital of Tradtional Chinese Medicine
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2007
Primary Completion (ACTUAL)
January 1, 2011
Study Completion (ACTUAL)
January 1, 2011
Study Registration Dates
First Submitted
October 11, 2007
First Submitted That Met QC Criteria
October 22, 2007
First Posted (ESTIMATE)
October 23, 2007
Study Record Updates
Last Update Posted (ESTIMATE)
August 7, 2013
Last Update Submitted That Met QC Criteria
August 5, 2013
Last Verified
August 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2006BAI04A02 (OTHER_GRANT: "Eleventh Five" program of China)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Stroke
-
University Hospital, GhentRecruitingStroke | Stroke, Ischemic | Stroke, Acute | Stroke Sequelae | Stroke HemorrhagicBelgium
-
Moleac Pte Ltd.RecruitingStroke | Stroke, Ischemic | Stroke Sequelae | Stroke, Cardiovascular | Strokes Thrombotic | Stroke, Embolic | Stroke, CryptogenicSingapore, Philippines
-
Moleac Pte Ltd.Not yet recruitingStroke | Stroke, Ischemic | Stroke Sequelae | Stroke, Cardiovascular | Strokes Thrombotic | Stroke, Embolic | Stroke, Cryptogenic
-
IRCCS San Camillo, Venezia, ItalyRecruitingStroke | Stroke, Ischemic | Stroke Sequelae | Stroke HemorrhagicItaly
-
Vanderbilt University Medical CenterPatient-Centered Outcomes Research Institute; University of Alabama at BirminghamEnrolling by invitationStroke | Stroke, Ischemic | Stroke, Acute | Stroke Sequelae | Engagement, Patient | Stroke HemorrhagicUnited States
-
University of MinnesotaAmerican Occupational Therapy FoundationRecruitingStroke | Stroke Sequelae | Stroke Hemorrhagic | Stroke IschemicUnited States
-
University of British ColumbiaCanadian Institutes of Health Research (CIHR); Michael Smith Foundation for...RecruitingStroke | Stroke, Ischemic | Stroke Hemorrhagic | Chronic StrokeCanada
-
University of CincinnatiMedical University of South Carolina; University of California, Los Angeles; University...RecruitingStroke | Stroke, Ischemic | Stroke, Acute | Stroke HemorrhagicUnited States
-
Turkish Stroke Research and Clinical Trials NetworkElectroCore INC; Turkish Neurological SocietyCompletedStroke | Stroke, Ischemic | Stroke, Acute | Stroke, HemorrhagicTurkey
-
University of LiegeCompletedStroke, Acute | Stroke Hemorrhagic | Stroke, ComplicationBelgium
Clinical Trials on Dengzhan Shengmai capsule
-
Beijing University of Chinese MedicineBeijing First Hospital of integrated Chinese and Western Medicine; Dongfang... and other collaboratorsUnknownIntradialytic HypotensionChina
-
Guang'anmen Hospital of China Academy of Chinese...UnknownCoronary Heart Disease | Stable Angina
-
Zhejiang Cancer HospitalRecruitingCardiotoxicity Induced by Drug Therapy for Breast CancerChina
-
Quan JiangUnknown
-
Guizhou Bailing Group Pharmaceutical Co LtdWangjing Hospital, China Academy of Chinese Medical Sciences; The First Affiliated... and other collaboratorsUnknownKnee OsteoarthritisChina
-
Jonsson Comprehensive Cancer CenterWithdrawnAcute Graft Versus Host Disease | Gastrointestinal Tract Acute Graft Versus Host Disease | Severe Gastrointestinal Tract Acute Graft Versus Host Disease | Steroid Resistant Gastrointestinal Tract Acute Graft Versus Host DiseaseUnited States
-
Yung Shin Pharm. Ind. Co., Ltd.Changhua Christian HospitalCompletedHot Flashes | PMSTaiwan
-
Hanmi Pharmaceutical Company LimitedUnknownChronic Obstructive Pulmonary Disease
-
Chipscreen Biosciences, Ltd.Not yet recruiting
-
Burapha UniversityCompletedAsparagus Capsule ConsumptionThailand