Clinical trial NCT00843765: Efficiency Study of Traditional Chinese Medicine (TCM) Versus Western Medicine (WM) on Ischemic Stroke
Official title: Program of TCM on Early Rehabilitation and Secondary Prevention of Ischemic Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Stroke
Traditional Chinese Medicine
Rehabilitation
Lead sponsor: China Academy of Chinese Medical Sciences
Sponsor class: OTHER
Collaborators: name: Dongzhimen Hospital, Beijing
name: Beijing Tiantan Hospital
First posted: 2009-02-13
Enrollment: 1151
Sex: ALL
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: NIHSS Stroke Scale, relapse rate
timeFrame: 360 days
Secondary outcomes:
measure: adverse event
timeFrame: 360 days
Other outcomes:
Locations:
city: Beijing
country: China
facility: China Academy of Chinese Medical Sciences
state: Beijing
Study officials:
affiliation: China Academy of Chinese Medical Sciences
name: Xie Y m
role: PRINCIPAL_INVESTIGATOR
References:
citation: Langhorne P, Ramachandra S; Stroke Unit Trialists' Collaboration. Organised inpatient (stroke unit) care for stroke: network meta-analysis. Cochrane Database Syst Rev. 2020 Apr 23;4(4):CD000197. doi: 10.1002/14651858.CD000197.pub4.