Clinical Trial: Efficacy and Safety of Qizhitongluo Capsule in the Recovery Phase of Ischemic Stroke
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: 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
Brief 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.
Detailed Summary:
Sponsor: China Academy of Chinese Medical Sciences
Current Primary Outcome: change in the Lower Extremity Fugl-Meyer score [ Time Frame: baseline, after 4,12 weeks of treatment, after 90 days of onset. ]
Original Primary Outcome: the Lower Extremity Fugl-Meyer score [ Time Frame: measured at baseline and 4, 8 and 12 weeks ]
Current Secondary Outcome:
- Change in Aphasia Quotient(AQ) score [ Time Frame: baseline, after 4,12 weeks of treatment, after 90 days of onset. ]
- Change in Barthel Index score and proportion of subjects with Barthel Index score ≥90 [ Time Frame: baseline, after 4,12 weeks of treatment, after 90 days of onset. ]
- Change in the Upper Extremity Fugl-Meyer score [ Time Frame: baseline, after 4,12 weeks of treatment, after 90 days of onset. ]
- Change in the total Fugl-Meyer motor score [ Time Frame: baseline, after 4,12 weeks of treatment, after 90 days of onset. ]
- Change in the syndrome score of Qi Deficiency and Blood Stasis [ Time Frame: baseline, after 4,12 weeks of treatment, after 90 days of onset. ]
- the incidence of New-onset cardiovascular events [ Time Frame: during the 20-weeks ]
- Changes in plasma glucose and lipid concentrations and blood coagulate [ Time Frame: baseline and after 12 weeks of treatment ]
- physical examination、 laboratory tests and ECG [ Time Frame: baseline and after 12 weeks of treatment ]
- the incidence of adverse events [ Time Frame: during the 20-weeks ]
- all cause mortality [ Time Frame: during the 20-weeks ]
Original Secondary Outcome:
- Aphasia Quotient(AQ) score [ Time Frame: measured at baseline and 4, 8 and 12 weeks ]the primary is at 12 weeks.
- the incidence of Barthel Index score ≥90 [ Time Frame: measured at baseline and 4, 8 and 12 weeks ]the primary is at 12 weeks.
- the Upper Extremity Fugl-Meyer score [ Time Frame: measured at baseline and 4, 8 and 12 weeks ]the primary is at 12 weeks.
- the total Fugl-Meyer motor score [ Time Frame: measured at baseline and 4, 8 and 12 weeks ]the primary is at 12 weeks.
- the syndrome score of Qi Deficiency and Blood Stasis [ Time Frame: measured at baseline and 4, 8 and 12 weeks ]the primary is at 12 weeks.
- the incidence of New-onset cardiovascular events [ Time Frame: during the 20-weeks ]
- the level of blood glucose (BG)、Lipid Profile、blood clotting tetrachoric [ Time Frame: measured at baseline and 12 weeks ]
- physical examination、 laboratory tests and ECG [ Time Frame: measured at baseline and 12 weeks ]
- the incidence of adverse events [ Time Frame: during the 20-weeks ]
- all cause mortality [ Time Frame: during the 20-weeks ]
- NHISS score [ Time Frame: measured at baseline and 4, 8 and 12 weeks ]the primary is at 12 weeks.
Information By: China Academy of Chinese Medical Sciences
Dates:
Date Received: January 4, 2013
Date Started: October 2013
Date Completion:
Last Updated: October 11, 2016
Last Verified: October 2016