The Second Prevention Trial for Ischemic Stroke With Dengzhan Shengmai Capsule (SPIRIT-DZSM-1)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2008 by Guangzhou University of Traditional Chinese Medicine.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Guangzhou University of Traditional Chinese Medicine
Information provided by:
Guangzhou University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier:
NCT00548223
First received: October 11, 2007
Last updated: September 16, 2008
Last verified: September 2008
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Purpose
In order to observe the secondary preventive effect of the Deng Zhan Sheng Mai capsule on ischemic stroke, the investigators hold the large randomized control trial (RCT). From January 2008 to December 2009, 3000 subjects are included in 60 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 | Intervention | Phase |
|---|---|---|
|
Stroke |
Drug: Dengzhan Shengmai capsule Drug: placebo |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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 |
Further study details as provided by Guangzhou University of Traditional Chinese Medicine:
Primary Outcome Measures:
- recurrence of stroke [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- incidence rate of cardiovascular events, and peripheral arterial events [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 3000 |
| Study Start Date: | January 2008 |
| Estimated Study Completion Date: | December 2009 |
| Estimated Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: Dengzhan Shengmai capsule
Capsule, 0.18g, 2#, Bid*1year
|
| Placebo Comparator: 2 |
Drug: placebo
Capsule, 0.18g, 2#, Bid*1year
|
Eligibility| Ages Eligible for Study: | 40 Years to 75 Years |
| Genders Eligible for Study: | Both |
| 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00548223
Contacts
| Contact: Yan fm Huang, Bachelor | (08620)81887233 ext 34530 | huang61@medmail.com.cn |
| Contact: Yefeng m Cai, Master | (08620)81887233 ext 34530 | caiyefeng@126.com |
Locations
| China, Guangdong | |
| Guangdong Province Hospital of Tradtional Chinese Medicine | Recruiting |
| Guangzhou, Guangdong, China, 510120 | |
| Contact: Yefeng Cai, Master (08620)81887233 ext 34530 caiyefeng@126.com | |
| Contact: Lixin Wang, MD (08620)81887233 ext 34530 plawlx@126.com | |
| Sub-Investigator: Yefeng Cai, Master | |
Sponsors and Collaborators
Guangzhou University of Traditional Chinese Medicine
Investigators
| Principal Investigator: | Yan Huang, Bachelor | Guangdong Province Hospital of Tradtional Chinese Medicine |
More Information
No publications provided
| Responsible Party: | Yan Huang/ Profeesor, Guangzhou University of Traditional Chinese Medicine |
| ClinicalTrials.gov Identifier: | NCT00548223 History of Changes |
| Other Study ID Numbers: | 2006BAI04A02, 2006BAI04A02 |
| Study First Received: | October 11, 2007 |
| Last Updated: | September 16, 2008 |
| Health Authority: | China: Ethics Committee China: Ministry of Health China: Food and Drug Administration |
Keywords provided by Guangzhou University of Traditional Chinese Medicine:
|
recurrence of stroke Dengzhan Shengmai Capsule Traditional Chinese Medicine |
Additional relevant MeSH terms:
|
Stroke Cerebral Infarction Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Vascular Diseases Cardiovascular Diseases Brain Infarction Brain Ischemia |
ClinicalTrials.gov processed this record on June 18, 2013