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 ]

the primary endpoint is at 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