Efficiency Study of Traditional Chinese Medicine (TCM) Versus Western Medicine (WM) on Ischemic Stroke

Completed

Phase N/A Results N/A

Trial Description

Complex project of Traditional Chinese Medicine (TCM) with Western Medicine (WM) project under stroke unit mode contrast,assuming that the efficiency of TCM on early rehabilitation and secondary prevention of ischemic stroke is same or better than that of WM.

Detailed Description

As a multi-site randomized controlled clinical trial,through a central system,patients were randomly assigned to the intervention group or the control group.In the intervention group, patients were treated with the traditional Chinese medicine comprehensive rehabilitation program, which includes traditional Chinese medicine syndrome differentiation herbs, Chinese medicine injection, wash foam Chinese medicine, acupuncture,massage, and Chinese medicine health education. In the control group, patients were treated with Western-based treatment plus modern rehabilitation techniques.All patients were treated for 2 weeks. At the first day after the treatment and the 14 days after treatment, each patient was evaluated for the following three clinical indications: (1)evaluation of neurological deficits by U.S. National Institutes of Health Stroke Scale (NIHSS);(2) evaluation of motor function by the short form Fugl-Meyer motor function scoring system (FMI); and (3) assessment of limb spasticity by the modified Ashworth spasticity rating scale.

Conditions

Interventions

  • Standard Medical Care Procedure
    Intervention Desc: per the National Guidelines for Stroke.
  • Traditional Chinese Medicine Other
    Other Names: Acupuncture; Tuina; Herbs; Moxabustion
    Intervention Desc: acupuncture, massage and basic Chinese medicine treatment
  • Acupuncture, massage and basic TCM treatment Other
    Other Names: 863 TCM project for ischemic stroke-TCM group
    Intervention Desc: During hospitalization:Patients accept TCM rehabilitation and basic treatment including WM basic treatment and Chinese medicine injection,decoction,herb soak treatment and health education. After discharge from hospital: In the TCM group,add prescriptions according to two conditions:a. patients using A injection (one Chinese herb injection admitted by SFDA) will take A' capsule (one Chinese herb capsule admitted by SFDA) for 6 months;b.patients using B injection (ditto) will take B' capsule (ditto) for 6 months.Both of them will accept TCM health education.In the WM group, patients are suggested with targeted rehabilitation programs according to different causes.
    ARM 1: Kind: Experimental
    Label: TCM integrated group
    Description: 800 patients with acupuncture, massage and basic Chinese medicine treatment
  • Rehabilitation and WM basic treatment Other
    Other Names: 863 TCM project for ischemic stroke-WM group
    Intervention Desc: there two steps: during hospitalization: patients accept modern rehabilitation and basic treatment of life supporting and medicine using and health education After discharge: make rehabilitation plans for patients including management of anticoagulant drugs, blood pressure, blood lipid and blood glucose, health education, and some suggestions for resisting alcohol ,smoking and reasonable diet
    ARM 1: Kind: Experimental
    Label: Western Medicine group
    Description: 400 patients with modern rehabilitation techniques and Western Medicine basic treatment

Trial Design

  • Allocation: Randomized
  • Masking: Open Label
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Patient Involvement

Patients will be randomly assigned to the intervention group or the control group. In the intervention group, patients were treated with the traditional Chinese medicine comprehensive rehabilitation program, which includes traditional Chinese medicine syndrome differentiation herbs, Chinese medicine injection, wash foam Chinese medicine, acupuncture, massage, and Chinese medicine health education. In the control group, patients were treated with Western-based treatment plus modern rehabilitation techniques. All patients are treated for 2 weeks. At the first day after the treatment and the 14 days after treatment, each patient was evaluated for the following three clinical indications: (1)evaluation of neurological deficits by U.S. National Institutes of Health Stroke Scale (NIHSS);(2) evaluation of motor function by the short form Fugl-Meyer motor function scoring system (FMI); and (3) assessment of limb spasticity by the modified Ashworth spasticity rating scale.

Outcomes

Type Measure Time Frame Safety Issue
Primary NIHSS Stroke Scale, relapse rate.
Secondary Adverse event.
Primary NIHSS Stroke Scale, relapse rate 360 days No
Secondary adverse event 360 days Yes

Sponsors