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

February 13, 2012 updated by: Yanming Xie, China Academy of Chinese Medical Sciences

Program of TCM on Early Rehabilitation and Secondary Prevention of Ischemic Stroke

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

1151

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100700
        • China Academy of Chinese Medical Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: TCM integrated group
800 patients with acupuncture, massage and basic Chinese medicine treatment
Other: 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.
Other Names:
  • 863 TCM project for ischemic stroke-TCM group
Active Comparator: Western Medicine group
400 patients with modern rehabilitation techniques and Western Medicine basic treatment
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
Other Names:
  • 863 TCM project for ischemic stroke-WM group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
NIHSS Stroke Scale, relapse rate
Time Frame: 360 days
360 days

Secondary Outcome Measures

Outcome Measure
Time Frame
adverse event
Time Frame: 360 days
360 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

China Academy of Chinese Medical Sciences

Collaborators

Beijing Tiantan Hospital
Dongzhimen Hospital, Beijing

Investigators

  • Principal Investigator: Xie Y m, China Academy of Chinese Medical Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2007

Primary Completion (Actual)

February 1, 2009

Study Completion (Actual)

November 1, 2010

Study Registration Dates

First Submitted

February 12, 2009

First Submitted That Met QC Criteria

February 12, 2009

First Posted (Estimate)

February 13, 2009

Study Record Updates

Last Update Posted (Estimate)

February 15, 2012

Last Update Submitted That Met QC Criteria

February 13, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2007AA02Z4B2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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