The Secondary Prevention Trial for Ischemic Stroke With DengzhanShengmai Capsule (SPIRITDZSM1)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00548223 |
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Recruitment Status :
Completed
First Posted : October 23, 2007
Last Update Posted : August 7, 2013
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Sponsor:
Guangzhou University of Traditional Chinese Medicine
Collaborators:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Nanhai Hospital of Traditional Chinese Medicine
People's hospital of Huizhou city
Taishan city hospital of TCM
Ruijin Hospital
First Affiliated Hospital of Fujian Medical University
Yangjiang City Hospital of TCM in Guangdong Province
Xinxing county hospital of TCM
Southern branch of yuexiu district hospital of TCM
Xinhui hospital of TCM of Jiangmen
Shanghai Pudong New Area People's Hospital
People's hospital of Jianyang city
Luzhou Medical College
Mianyang city hospital of TCM
Guangyuan city hospital of TCM of Sichuan Province
The Third Affiliated Hospital of Guangzhou Medical University
Shunde district hospital of TCM
Shenzhen People's Hospital
Anyue County Hospital of Traditional Chinese
Chengdu Integrated TCM&Western Medicine Hospital
Guangzhou Red Cross Hospital
Jiangsu Provincial People's Hospital
Ankang Hospital of Traditional Chinese Medicine
Qishan county hospital of shaanxi province
Zongrui Hospital
First Affiliated Hospital of Xinjiang Medical University
Lianyungang Chinese Medicine Hospital
Yufu City Hospital of TCM in Guangdong Province
169 Military Hospital of China
The affiliated hospital of Liaoning University of Traditional Chinese Medicine
The second affiliated hospital of shanxi college of TCM
URUMQI Hospital of Traditional Chinese Medicine
Hubei General Hospital
The People's Hospital of Leshan
Guagnzhou Liwan district Hospital of TCM
Longhua Hospital
Shanghai Jiao Tong University School of Medicine
Hangzhou City Hospital of TCM
Dongguan city hospital of TCM
Liuzhou City hospital of TCM
Maoming city hospital of TCM
Beijing Tiantan Hospital
Affiliated Hospital of Nantong University
Xi'an city hospital of TCM
Jiangsu province hospital of TCM
The Third People's Hospital of Chengdu
Huizhou Municipal Central Hospital
Zhejiang Provincial Hospital of TCM
The Second People's Hospital of Yibin
Shanxi Provincial People's Hospital
The First Affiliated Hospital of Guangzhou Medical University
Guangxi Ruikang Hospital
Third Affiliated Hospital, Sun Yat-Sen University
First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Affiliated Hospital of North Sichuan Medical College
The Third Affiliated Hospital of Henan University of Traditional Chinese Medicine
ZhuHai Hospital
Nanfang Hospital of Southern Medical University
West China Hospital
Guangdong Second Provincial Traditional Chinese Medicine Hospital
The First Hospital of Handan City
The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine
Conghua city hospital of TCM
The First Affiliated Hospital of Guangxi University of Chinese Medicine
Hubei Hospital of Traditional Chinese Medicine
Jinan city hospital of TCM
Shaanxi Hospital of Traditional Chinese Medicine
Suining People's Hospital
Wuzhou Red Cross Hospital
Wuhan Interated ＆Western Hospital
Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an Central Hospital
Zhengzhou City Hospital of Traditional Chinese Medicine
Xiangya Hospital of Central South University
Second Affiliated Hospital, Sun Yat-Sen University
The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
ShuGuang Hospital
Zhongshan Hospital Of Traditional Chinese Medicine
Foshan Hospital of Traditional Chinese Medicine
Teaching Hospital of Chengdu University of TCM
Jiangmen Wuyi Traditional Chinese Medicine Hospital
Guangdong Provincial Hospital of Traditional Chinese Medicine
Information provided by (Responsible Party):
jianwen guo, MD, Guangzhou University of Traditional Chinese Medicine
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Stroke | Drug: Dengzhan Shengmai capsule Drug: placebo | Phase 4 |
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 (Clinical Trial) |
| Actual Enrollment : | 3143 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Prevention |
| Official Title: | Model Study on the Comprehensive Treating Protocol and Effect Evaluation of Ischemic Stroke With Traditional Chinese Medicine |
| Study Start Date : | December 2007 |
| Actual Primary Completion Date : | January 2011 |
| Actual Study Completion Date : | January 2011 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Ischemic Stroke
| Arm | Intervention/treatment |
|---|---|
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Experimental: Dengzhan Shengmai capsule
Dengzhan Shengmai capsule 0.18g by mouth twice a day for 1year
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Drug: Dengzhan Shengmai capsule
Capsule, 0.18g, 2#, Bid*1year
Other Name: DZSM |
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Placebo Comparator: Placebo
Placebo 0.18g by mouth twice a day for 1year
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Drug: placebo
Capsule, 0.18g, 2#, Bid*1year
Other Name: DZSMP |
Primary Outcome Measures :
- recurrence of stroke [ Time Frame: 1 year ]
Secondary Outcome Measures :
- incidence rate of cardiovascular events, and peripheral arterial events [ Time Frame: 1 year ]
Information from the National Library of Medicine
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| Ages Eligible for Study: | 40 Years to 75 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00548223
Locations
Show 84 study locations
Sponsors and Collaborators
Guangzhou University of Traditional Chinese Medicine
Second Affiliated Hospital, School of Medicine, Zhejiang University
Nanhai Hospital of Traditional Chinese Medicine
People's hospital of Huizhou city
Taishan city hospital of TCM
Ruijin Hospital
First Affiliated Hospital of Fujian Medical University
Yangjiang City Hospital of TCM in Guangdong Province
Xinxing county hospital of TCM
Southern branch of yuexiu district hospital of TCM
Xinhui hospital of TCM of Jiangmen
Shanghai Pudong New Area People's Hospital
People's hospital of Jianyang city
Luzhou Medical College
Mianyang city hospital of TCM
Guangyuan city hospital of TCM of Sichuan Province
The Third Affiliated Hospital of Guangzhou Medical University
Shunde district hospital of TCM
Shenzhen People's Hospital
Anyue County Hospital of Traditional Chinese
Chengdu Integrated TCM&Western Medicine Hospital
Guangzhou Red Cross Hospital
Jiangsu Provincial People's Hospital
Ankang Hospital of Traditional Chinese Medicine
Qishan county hospital of shaanxi province
Zongrui Hospital
First Affiliated Hospital of Xinjiang Medical University
Lianyungang Chinese Medicine Hospital
Yufu City Hospital of TCM in Guangdong Province
169 Military Hospital of China
The affiliated hospital of Liaoning University of Traditional Chinese Medicine
The second affiliated hospital of shanxi college of TCM
URUMQI Hospital of Traditional Chinese Medicine
Hubei General Hospital
The People's Hospital of Leshan
Guagnzhou Liwan district Hospital of TCM
Longhua Hospital
Shanghai Jiao Tong University School of Medicine
Hangzhou City Hospital of TCM
Dongguan city hospital of TCM
Liuzhou City hospital of TCM
Maoming city hospital of TCM
Beijing Tiantan Hospital
Affiliated Hospital of Nantong University
Xi'an city hospital of TCM
Jiangsu province hospital of TCM
The Third People's Hospital of Chengdu
Huizhou Municipal Central Hospital
Zhejiang Provincial Hospital of TCM
The Second People's Hospital of Yibin
Shanxi Provincial People's Hospital
The First Affiliated Hospital of Guangzhou Medical University
Guangxi Ruikang Hospital
Third Affiliated Hospital, Sun Yat-Sen University
First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Affiliated Hospital of North Sichuan Medical College
The Third Affiliated Hospital of Henan University of Traditional Chinese Medicine
ZhuHai Hospital
Nanfang Hospital of Southern Medical University
West China Hospital
Guangdong Second Provincial Traditional Chinese Medicine Hospital
The First Hospital of Handan City
The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine
Conghua city hospital of TCM
The First Affiliated Hospital of Guangxi University of Chinese Medicine
Hubei Hospital of Traditional Chinese Medicine
Jinan city hospital of TCM
Shaanxi Hospital of Traditional Chinese Medicine
Suining People's Hospital
Wuzhou Red Cross Hospital
Wuhan Interated ＆Western Hospital
Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an Central Hospital
Zhengzhou City Hospital of Traditional Chinese Medicine
Xiangya Hospital of Central South University
Second Affiliated Hospital, Sun Yat-Sen University
The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
ShuGuang Hospital
Zhongshan Hospital Of Traditional Chinese Medicine
Foshan Hospital of Traditional Chinese Medicine
Teaching Hospital of Chengdu University of TCM
Jiangmen Wuyi Traditional Chinese Medicine Hospital
Guangdong Provincial Hospital of Traditional Chinese Medicine
Investigators
| Principal Investigator: | Yan Huang, Bachelor | Guangdong Provincial Hospital of Tradtional Chinese Medicine |
Additional Information:
| Responsible Party: | jianwen guo, MD, Professor, Guangzhou University of Traditional Chinese Medicine |
| ClinicalTrials.gov Identifier: | NCT00548223 |
| Other Study ID Numbers: |
2006BAI04A02 2006BAI04A02 ( Other Grant/Funding Number: "Eleventh Five" program of China ) |
| First Posted: | October 23, 2007 Key Record Dates |
| Last Update Posted: | August 7, 2013 |
| Last Verified: | August 2013 |
Keywords provided by jianwen guo, MD, Guangzhou University of Traditional Chinese Medicine:
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recurrence of stroke Dengzhan Shengmai Capsule Traditional Chinese Medicine |
Additional relevant MeSH terms:
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Stroke Ischemic Stroke Cerebrovascular Disorders Brain Diseases |
Central Nervous System Diseases Nervous System Diseases Vascular Diseases Cardiovascular Diseases |