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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
622
The First Affiliated Hospital of Guangxi University of Chinese Medicine
Nanning, Guangxi, China
Langfang TCM Hospital
Langfang, Hebei, China
Luohe Hospital of Chinese Medicine
change in the Lower Extremity Fugl-Meyer score
Time frame: baseline, after 4,12 weeks of treatment, after 90 days of onset.
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
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Luohe, Henan, China
the First affiliated Hospital of Henan University of TCM
Zhengzhou, Henan, China
the affiliated Hospital to Changchun University of Chinese Medicine
Changchun, Jilin, China
201 Hospital of People's Liberation Army
Dalian, Liaoning, China
Zhongshan Hospital Dalian University
Dalian, Liaoning, China
Second Hospital affiliated to Liaoning University of Traditional Chinese Medicine
Shenyang, Liaoning, China
Teaching Hospital of Chengdu University of Traditional Chinese Medicine
Chengdu, Sichuan, China
West China Hospital,Sichuan University
Chengdu, Sichuan, China
...and 3 more locations
all cause mortality
Time frame: during the 20-weeks