- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02454166
The Analysis of Chinese Medical Syndromes Differentiation on Acute Ischemic Stroke
May 26, 2015 updated by: Chang Gung Memorial Hospital
The Study of Chinese Medical Syndromes on Common Diseases: The Analysis of Chinese Medical Syndromes Differentiation on Acute Ischemic Stroke
Background and objective: Stroke, which means sudden onset of cerebral vascular accident.
The earliest document was found in "Neijing".
The ancient physicians had different opinions and points of view on the etiology and pathogenesis of stroke.
Before the Tang and Song dynasty, the "exopathic wind" theory was talked about.
And, after then, the "endogenous wind" theory was put forward.
While in the Ming dynasty, Zhang Jing-Yue advocated that "Stroke is not caused by wind etiology'', highlighting the much difference of the thinking.
Until nowadays, many famous physicians have their own unique way to determine the etiologic factor based on differentiation.
To be practical, objectivity differentiating and determining the etiologic factor of stroke is the foundation of establishing the treatment guidelines.
The investigators aim to establish the scientific epidemiological standard of traditional Chinese Medicine (TCM) syndromes of acute ischemic stroke in Taiwan.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
Methods: The investigators use the ischemic stroke TCM syndromes Diagnostic Scale (ISTCMDS) and the Meridian Energy Analysis Device (M.E.A.D.) to objectively analyze the diagnostic elements and detect the deficiency or excess performance of meridians of acute ischemic stroke patients from Stroke Center at Linkou Chang Gung Memorial Hospital.
The onset of stroke is set Within 7 days, and the investigators expected to collect 300 patients.
The investigators initially establish the scientific epidemiological study of acute ischemic stroke with TCM syndromes and deficiency or excess of meridian performances through statistical analysis to become a standard of Chinese and Western medicine integration.
The data collection can gradually become a library, which will facilitate the assessment of the clinical efficacy of TCM adjuvant therapy and become a basis to assist Western and Chinese medicine integration.
Study Type
Observational
Enrollment (Anticipated)
300
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
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
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Acute ischemic stroke patients from Stroke Center at Linkou Chang Gung Memorial Hospital.
The onset of stroke is set Within 7 days.
Description
Inclusion Criteria:
- Patient with acute ischemic stroke, approved by brain CT or MRI
- Onset within 7 days
- No other severe organic diseases
- Stroke for the first time or recurrent stroke with previous Rankin's scale ≦1 status
- Signed Inform Consent
Exclusion Criteria:
- Not meet the above diagnostic and inclusion criteria
- Complicated with sepsis or other infections
- Refuse to accept Chinese Medical syndromes differentiation, the Meridian Energy Analysis Device (M.E.A.D.), or refuse to sign Inform Consent
- Unconsciousness
- With pacemaker or pregnancy
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Chinese medical syndromes differentiation by Ischemic stroke TCM syndromes Diagnostic Scale (ISTCMDS) in acute stroke patients
Time Frame: within 7 days from the onset of the stroke
|
within 7 days from the onset of the stroke
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Shu-chen Cheng, Department of Traditional Chinese Medicine, Chang Gung Memorial Hospital at Linkou
- Study Chair: YEU-JHY CHANG, Stroke Center and Department of Neurology, Chang Gung Memorial Hospital at Linkou
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
May 1, 2015
Primary Completion (Anticipated)
March 1, 2016
Study Completion (Anticipated)
March 1, 2016
Study Registration Dates
First Submitted
May 22, 2015
First Submitted That Met QC Criteria
May 26, 2015
First Posted (Estimate)
May 27, 2015
Study Record Updates
Last Update Posted (Estimate)
May 27, 2015
Last Update Submitted That Met QC Criteria
May 26, 2015
Last Verified
April 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 104-2081B
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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