Curative Efficacy of Secondary Prevention for Patients With Ischemic Stroke Through Syndrome Differentiation of TCM

Recruiting

Phase 4 Results N/A

Trial Description

The purpose of this study is to assess the efficacy and safety of Naoxintong Capsule in the secondary prevention of ischemic stroke by the multi-center, randomized,double-blind,placebo-controlled trial design project.

Detailed Description

The research employs a random, double-blind, multicenter, placebo parallel and controlled design to observe the clinical effect of Naoxintong capsule in the treatment in ischemic stroke of the blood stasis syndrome on the secondary prevention,which is funded by Science and Technology Commission of Shanghai Municipality.The therapeutic drug of the research is Naoxintong capsule on the market for treatment and prevention of stroke, applicable to stroke patients caused by qi deficiency, blood stasis and venation stasis.The research will be carried out in 24 hospitals.It is a total number of 2200 volunteers,who will meet the inclusion criteria other than the exclusion criteria and agree to participate in the research.Volunteers will be randomly assigned to the experimental group or the control group. The trial drug for the experimental group is Naoxintong capsule, while that for the control group is a kind of placebo capsule.Volunteers will be regularly followed up during the experimental period of 2 years. It will be to evaluate the clinical efficacy of Naoxintong capsule on the secondary prevention by the stroke recurrence and mortality.

Conditions

Interventions

  • Placebo Drug
    Intervention Desc: placebo capsule has the same as Naoxintong capsule in the appearance, shape,colour and content tinct.
    ARM 1: Kind: Experimental
    Label: Control group
    Description: On the basis of the secondary prevention of ischemic stroke,Volunteers will be taken Placebo capsule,which is identical with Naoxintong capsule in the appearance, shape, color and content, 2 times a day, three granule per time
  • Naoxintong Capsule Drug
    Other Names: Chinese Herbal Compound
    Intervention Desc: This is Naoxintong capsule,which is composed of Huangqi,Chishao,Danshen,Danggui, Chuanxiong,Taoren,Honghua,Ruxiang,Moyao,Jixueteng,Niuxi,Guizhi,Sangzhi,Dilong,Quanxie,etal.
    ARM 1: Kind: Experimental
    Label: Experimental group
    Description: On the basis of the secondary prevention of ischemic stroke,Volunteers will be taken Naoxintong capsule, 2 times a day, three granule per time

Trial Design

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

Outcomes

Type Measure Time Frame Safety Issue
Primary Stroke recurrence rate and Stroke mortality 2 years No
Secondary The incidence rate of myocardial infarction 2 years No
Secondary All-cause mortality 2 years No

Sponsors