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

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.

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

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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