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Efficacy and Safety of Qizhitongluo Capsule in the Recovery Phase of Ischemic Stroke With Qi Deficiency and Blood Stasis Syndrome: a Multicenter, Randomized,Double-blind，Placebo- and Active-controlled Adaptive Study
This is a 20-week study consisting of a 12-week multicenter, randomized,double-blind adaptive study to compare efficacy and safety of Qizhitongluo Capsule,Naoxintong Capsule and placebo in the recovery phase of ischemic stroke with qi deficiency and blood stasis syndrome, and a 8-week post-treatment safety follow-up.After 312 patients complete 12 weeks of treatment there will be an interim analysis.
Details
| Lead sponsor | China Academy of Chinese Medical Sciences |
|---|---|
| Phase | Phase 4 |
| Status | COMPLETED |
| Enrolment | 622 |
| Start date | 2013-10 |
| Completion | 2016-10 |
Conditions
- Ischemic Stroke
Interventions
- Qizhitongluo Capsule
- Naoxintong Capsule
- Aspirin Enteric-coated Tablets
- the routine recovery training
- placebo
Primary outcomes
- change in the Lower Extremity Fugl-Meyer score — baseline, after 4,12 weeks of treatment, after 90 days of onset.
Countries
China