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Model Study on the Comprehensive Treating Protocol and Effect Evaluation of Ischemic Stroke With Traditional Chinese Medicine (SPIRITDZSM1)
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.
Details
| Lead sponsor | Guangzhou University of Traditional Chinese Medicine |
|---|---|
| Phase | Phase 4 |
| Status | COMPLETED |
| Enrolment | 3143 |
| Start date | 2007-12 |
| Completion | 2011-01 |
Conditions
- Stroke
Interventions
- Dengzhan Shengmai capsule
- placebo
Primary outcomes
- recurrence of stroke — 1 year
Countries
China