Clinical trial NCT02454166: The Analysis of Chinese Medical Syndromes Differentiation on Acute Ischemic Stroke
Official title: The Study of Chinese Medical Syndromes on Common Diseases: The Analysis of Chinese Medical Syndromes Differentiation on Acute Ischemic Stroke
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ischemic Stroke
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2015-05-27
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Chinese medical syndromes differentiation by Ischemic stroke TCM syndromes Diagnostic Scale (ISTCMDS) in acute stroke patients
timeFrame: within 7 days from the onset of the stroke
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Department of Traditional Chinese Medicine, Chang Gung Memorial Hospital at Linkou
name: Shu-chen Cheng
role: STUDY_CHAIR
affiliation: Stroke Center and Department of Neurology, Chang Gung Memorial Hospital at Linkou
name: YEU-JHY CHANG
role: STUDY_CHAIR
References: