Efficiency Study of Traditional Chinese Medicine (TCM) Versus Western Medicine (WM) on Ischemic Stroke
Program of TCM on Early Rehabilitation and Secondary Prevention of Ischemic Stroke
1 other identifier
interventional
1,151
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable stroke
Started Dec 2007
Typical duration for not_applicable stroke
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2009
CompletedFirst Submitted
Initial submission to the registry
February 12, 2009
CompletedFirst Posted
Study publicly available on registry
February 13, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2010
CompletedFebruary 15, 2012
February 1, 2012
1.2 years
February 12, 2009
February 13, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
NIHSS Stroke Scale, relapse rate
360 days
Secondary Outcomes (1)
adverse event
360 days
Study Arms (2)
TCM integrated group
ACTIVE COMPARATOR800 patients with acupuncture, massage and basic Chinese medicine treatment
Western Medicine group
ACTIVE COMPARATOR400 patients with modern rehabilitation techniques and Western Medicine basic treatment
Interventions
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.
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- China Academy of Chinese Medical Scienceslead
- Dongzhimen Hospital, Beijingcollaborator
- Beijing Tiantan Hospitalcollaborator
Study Sites (1)
China Academy of Chinese Medical Sciences
Beijing, Beijing Municipality, 100700, China
Related Publications (1)
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.
PMID: 32324916DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Xie Y m
China Academy of Chinese Medical Sciences
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Deputy Director
Study Record Dates
First Submitted
February 12, 2009
First Posted
February 13, 2009
Study Start
December 1, 2007
Primary Completion
February 1, 2009
Study Completion
November 1, 2010
Last Updated
February 15, 2012
Record last verified: 2012-02