The Secondary Prevention Trial for Ischemic Stroke With DengzhanShengmai Capsule "SPIRITDZSM1"

Completed

Phase 4 Results N/A

Trial Description

In order to observe the secondary preventive effect of the Dengzhanshengmai capsule on ischemic stroke, the investigators hold the large randomized control trial (RCT). 3143 subjects are included in 83 clinical research centers all over China. The subjects are randomly grouped into two groups. The basic therapy included antiplatelet aggregation, stroke health education, management of blood pressure, blood lipid and blood glucose, etc. The treating group will take the compound Chinese Medicine Deng Zhan Sheng Mai capsule and the contrast group will take the placebo for twelve months. Then all of the subjects are visited on the 30th, 90th, 180th, 360th day after inclusion. The recurrence of stroke, cardiovascular events, and peripheral arterial events are observed.

Detailed Description

Objective:To observe the secondary clinical effect of the Deng Zhan Sheng Mai capsule on ischemic stroke patients.
Methods:3143 subjects suffering from acute ischemic stroke are included in 83 clinical research centers all over China. The subjects are randomly divided into two groups:The treating group and the placebo group.Both groups accept the basic therapy and test drug.The basic therapy included antiplatelet aggregation,stroke health education,management of blood pressure,blood lipid and blood glucose,etc.The patients in Dengzhan Shengmaigroup take Deng Zhan Sheng Mai capsule and the placebo group take the placebo drug for twelve months.Then all of the subjects are visited on the 30th,90th,180th,360th day after inclusion. Primary endpoints(cerebral infarction,intracerebral hemorrhage,subarachnoid hemorrhage) and secondary endpoints(cardiovascular events,peripheral arterial disease),functional disability are observed at each follow up.

Conditions

Interventions

  • Placebo Drug
    Intervention Desc: Capsule, 0.18g, 2#, Bid*1year
    ARM 1: Kind: Experimental
    Label: 2
    ARM 2: Kind: Experimental
    Label: Placebo
    Description: Placebo 0.18g by mouth twice a day for 1year
  • Dengzhan Shengmai capsule Drug
    Other Names: DZSM
    Intervention Desc: Capsule, 0.18g, 2#, Bid*1year
    ARM 1: Kind: Experimental
    Label: 1
    ARM 2: Kind: Experimental
    Label: Dengzhan Shengmai capsule
    Description: Dengzhan Shengmai capsule 0.18g by mouth twice a day for 1year

Trial Design

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

Outcomes

Type Measure Time Frame Safety Issue
Primary recurrence of stroke 1 year Yes
Secondary incidence rate of cardiovascular events, and peripheral arterial events 1 year Yes

Sponsors