The purpose of this study is to assess the effects in improving life self-care ability of stroke patients after taking Tongxinluo Capsule(within 72 hours after onset) versus Placebos for 90 days.
The study is a randomized, double-blind, placebo controlled, multi-center trial. We aim to enroll a total of 1968 individuals(984 cases in each group) with acute ischemic stroke less than 72 hours after onset. Participants will be randomized into Tongxinluo capsule treatment group with the capsule administration of 4 granules tid. for 90 days, while the patients in the control group receive placebo capsule. NIH Stroke Score of the subjects is 4-22 at randomization. Evaluations of efficacy and safety will be taken at baseline, 7 days, discharge date and 90 days. Neuroimaging \[magnetic resonance imaging (MRI) scans\] will be obtained at baseline and 90 days after therapy. The primary efficacy endpoint is the proportion of Modified Rankin Scale (mRS) ≤1 at 90 days.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
2,007
for 90 days
for 90 days
Beijing TianTan Hospital,Capital Medical University
Beijing, China
Proportion of patients with Modified Rankin Scale (mRS) less than or equal to 1 at 90 days.
Time frame: 90 days
Proportion of patients with National Institutes of Health Stroke Score (NIHSS) reaching 0-1 or reduction 4 points .
Time frame: Baseline, 7days, discharge date, 90 days
Proportion of patients with Bathel Index(BI)score more than 85.
Time frame: Baseline, 7days, discharge date, 90 days
Continuous changes of Modified Rankin Scale score.
Time frame: Baseline, 7days, discharge date, 90 days
Incidence of ischemic cerebrovascular disease (ischemic stroke/TIA/ new ischemic lesion in MRI Images.
Time frame: 90 days
Incidence of new combination clinical vascular events (ischemic stroke/ hemorrhagic stroke/ TIA/ MI/ vascular death).
Time frame: 90 days
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