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

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
acupuncture, massage and basic TCM treatment
rehabilitation and WM basic treatment
Sponsored by
China Academy of Chinese Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Stroke, Traditional Chinese Medicine, Rehabilitation

Eligibility Criteria

35 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • China Academy of Chinese Medical Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

TCM integrated group

Western Medicine group

Arm Description

800 patients with acupuncture, massage and basic Chinese medicine treatment

400 patients with modern rehabilitation techniques and Western Medicine basic treatment

Outcomes

Primary Outcome Measures

NIHSS Stroke Scale, relapse rate

Secondary Outcome Measures

adverse event

Full Information

First Posted
February 12, 2009
Last Updated
February 13, 2012
Sponsor
China Academy of Chinese Medical Sciences
Collaborators
Dongzhimen Hospital, Beijing, Beijing Tiantan Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00843765
Brief Title
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

2. Study Status

Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
December 2007 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
November 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
China Academy of Chinese Medical Sciences
Collaborators
Dongzhimen Hospital, Beijing, Beijing Tiantan Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Stroke, Traditional Chinese Medicine, Rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1151 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TCM integrated group
Arm Type
Active Comparator
Arm Description
800 patients with acupuncture, massage and basic Chinese medicine treatment
Arm Title
Western Medicine group
Arm Type
Active Comparator
Arm Description
400 patients with modern rehabilitation techniques and Western Medicine basic treatment
Intervention Type
Other
Intervention Name(s)
acupuncture, massage and basic TCM treatment
Other Intervention Name(s)
863 TCM project for ischemic stroke-TCM group
Intervention Description
During hospitalization:Patients accept TCM rehabilitation and basic treatment including WM basic treatment and Chinese medicine injection,decoction,herb soak treatment and health education. 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
Intervention Name(s)
rehabilitation and WM basic treatment
Other Intervention Name(s)
863 TCM project for ischemic stroke-WM group
Intervention Description
there two steps: during hospitalization: patients accept modern rehabilitation and basic treatment of life supporting and medicine using and health education 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
Primary Outcome Measure Information:
Title
NIHSS Stroke Scale, relapse rate
Time Frame
360 days
Secondary Outcome Measure Information:
Title
adverse event
Time Frame
360 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xie Y m
Organizational Affiliation
China Academy of Chinese Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
China Academy of Chinese Medical Sciences
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100700
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
32324916
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.
Results Reference
derived

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

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