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

NCT ID: NCT00843765

Last Updated: 2012-02-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1151 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-12-31

Study Completion Date

2010-11-30

Brief Summary

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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

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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

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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TCM integrated group

800 patients with acupuncture, massage and basic Chinese medicine treatment

Group Type ACTIVE_COMPARATOR

acupuncture, massage and basic TCM treatment

Intervention Type OTHER

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.

Western Medicine group

400 patients with modern rehabilitation techniques and Western Medicine basic treatment

Group Type ACTIVE_COMPARATOR

rehabilitation and WM basic treatment

Intervention Type OTHER

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

Interventions

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acupuncture, 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.

Intervention Type OTHER

rehabilitation 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

Intervention Type OTHER

Other Intervention Names

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863 TCM project for ischemic stroke-TCM group 863 TCM project for ischemic stroke-WM group

Eligibility Criteria

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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
Minimum Eligible Age

35 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dongzhimen Hospital, Beijing

OTHER

Sponsor Role collaborator

Beijing Tiantan Hospital

OTHER

Sponsor Role collaborator

China Academy of Chinese Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Yanming Xie

Deputy Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Xie Y m

Role: PRINCIPAL_INVESTIGATOR

China Academy of Chinese Medical Sciences

Locations

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China Academy of Chinese Medical Sciences

Beijing, Beijing Municipality, China

Site Status

Countries

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China

References

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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.

Reference Type DERIVED
PMID: 32324916 (View on PubMed)

Other Identifiers

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2007AA02Z4B2

Identifier Type: -

Identifier Source: org_study_id

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