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

Not Applicable

Completed

• Conditions: Stroke
• Interventions: Other: acupuncture, massage and basic TCM treatment; Other: rehabilitation and WM basic treatment

• Registration Number: NCT00843765
• Lead Sponsor: China Academy of Chinese Medical Sciences

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.

Study Timeline

• Study Start: 2007-12
• Primary Completion: 2009-02
• Study First Submitted: 2009-02-12
• Study First Submitted QC: 2009-02-12
• Study First Posted: 2009-02-13
• Study Completion: 2010-11
• Status Verified: 2012-02
• Last Update Submitted: 2012-02-13
• Last Update Posted: 2012-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1151

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TCM integrated group	acupuncture, massage and basic TCM treatment	800 patients with acupuncture, massage and basic Chinese medicine treatment
Western Medicine group	rehabilitation and WM basic treatment	400 patients with modern rehabilitation techniques and Western Medicine basic treatment

Primary Outcome Measures

Name	Time	Method
NIHSS Stroke Scale, relapse rate	360 days

Secondary Outcome Measures

Name	Time	Method
adverse event	360 days

Trial Locations

Locations (1)

China Academy of Chinese Medical Sciences; 🇨🇳 Beijing, Beijing, China