A Phase 4 interventional study of Tongxinluo capsule and placebo capsule in Ischemic Stroke, sponsored by yongjun wang. Completed at 1 site in China. Open to participants aged 35 Years to 75 Years. Per ClinicalTrials.gov, last updated 2017-01-04.
Sponsored by yongjun wang · Phase 4, Interventional, and Treatment
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.
7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.
This study's enrollment of 2,007 is above the median of 50 across 5,369 interventional studies indexed under Stroke.
Browse Stroke studies →yongjun wang is the lead sponsor of 5 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Tongxinluo capsule,4 granules,t.i.d. po,for 90 days
Drug: Tongxinluo capsule
placebo capsule,4 granules,t.i.d. po,for 90 days
Drug: placebo capsule
for 90 days
Also known as: Yiling Pharmaceutical，Z19980015
for 90 days
Also known as: placebo
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
MR indicated symptomatic or non-symptomatic cerebral infarction emerging
Compared with baseline MRI, re-examination of MRI shows new infarct diagnosed by DWI or FLARI (including new infarct and enlargement of infarct size) in areas other than the original infarct in DWI and FLAIR-sequence.
Time frame: 90 days
Plan to share: No
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This study is completed, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.
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