NCT01762163

Efficacy and Safety of Qizhitongluo Capsule in the Recovery Phase of Ischemic Stroke

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 622 (actual)
• Sponsor: China Academy of Chinese Medical Sciences · Academic / Other
• Sex: All
• Age: 35 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Ischemic Stroke

Interventions

Type	Name	Description
DRUG	Qizhitongluo Capsule
DRUG	Naoxintong Capsule
DRUG	Aspirin Enteric-coated Tablets
BEHAVIORAL	the routine recovery training
DRUG	placebo

Timeline

• Start date: 2013-10-01
• Primary completion: 2016-10-01
• Completion: 2016-10-01
• First posted: 2013-01-07
• Last updated: 2016-10-12

Locations

13 sites across 1 country: China