Stroke
Conditions
Keywords
Stroke, Traditional Chinese Medicine, Rehabilitation
Brief summary
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.
Interventions
OTHERacupuncture, massage and basic TCM treatment
1. During hospitalization:Patients accept TCM rehabilitation and basic treatment including WM basic treatment and Chinese medicine injection,decoction,herb soak treatment and health education. 2. 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.
OTHERrehabilitation and WM basic treatment
there two steps: 1. during hospitalization: patients accept modern rehabilitation and basic treatment of life supporting and medicine using and health education 2. 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
Sponsors
Dongzhimen Hospital, Beijing
Beijing Tiantan Hospital
China Academy of Chinese Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
35 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* According with the stroke diagnosis of Traditional Chinese Medicine * According to atherosclerotic thrombotic cerebral infarction from Western diagnosis such as medical history and CT / MRI examinations * It has attacked in 7 days * The assessment of scale of NIHSS:4-24 points * Age: ≥ 35 years and ≤ 75 years * Patients or their legal guardians sign informed consent form
Exclusion criteria
* The patients with ICH or cerebral hemorrhage or TIA * It has attacked beyond 7 days * Patients with stroke history and the mRS ≥ 2 points before this attack * Mixed type of stroke (infarction after bleeding or bleeding after infarction) * Patients with cerebral infarction by cardiogenic embolism, blood hypercoagulable state and tunica intima exfoliating * Patients with serious heart disease;failure of heart or liver or kidney; cancer;digestive tract bleeding * Women of pregnancy or breast-feeding * Patients who are taking part in other clinical trials that will influence the results of this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| NIHSS Stroke Scale, relapse rate | 360 days |
Secondary
| Measure | Time frame |
|---|---|
| adverse event | 360 days |
Countries
China
Outcome results
None listed