Tongxinluo Capsule in Ischemic Stroke Patients(TISS)

Not yet recruiting

Phase 4 Results N/A

Trial Description

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.

Detailed Description

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.

Conditions

Interventions

  • Tongxinluo capsule Drug
    Intervention Desc: for 90 days
    ARM 1: Kind: Experimental
    Label: Tongxinluo capsule
    Description: Tongxinluo capsule,4 granules,t.i.d. po,for 90 days
  • Placebo capsule Drug
    Intervention Desc: for 90 days
    ARM 1: Kind: Experimental
    Label: placebo capsule
    Description: placebo capsule,4 granules,t.i.d. po,for 90 days

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Proportion of patients with Modified Rankin Scale (mRS) less than or equal to 1 at 90 days. 90 days No
Secondary Proportion of patients with National Institutes of Health Stroke Score (NIHSS) reaching 0-1 or reduction 4 points . Baseline, 7days, discharge date, 90 days No
Secondary Proportion of patients with Bathel Index(BI)score more than 85. Baseline, 7days, discharge date, 90 days No
Secondary Continuous changes of Modified Rankin Scale score. Baseline, 7days, discharge date, 90 days No
Secondary Incidence of ischemic cerebrovascular disease (ischemic stroke/TIA/ new ischemic lesion in MRI Images). 90 days Yes
Secondary Incidence of new combination clinical vascular events (ischemic stroke/ hemorrhagic stroke/ TIA/ MI/ vascular death). 90 days Yes

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