Ischemic StrokeNCT02454166
The Analysis of Chinese Medical Syndromes Differentiation on Acute Ischemic Stroke
An observational study of Ischemic Stroke, run by Chang Gung Memorial Hospital.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- Ischemic stroke TCM syndromes Diagnostic Scale and Meridian Energy Analysis Device
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- May 2015to Mar 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Acute ischemic stroke patients from Stroke Center at Linkou Chang Gung Memorial Hospital. The onset of stroke is set Within 7 days.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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.
- Conditions
- Ischemic Stroke
- Being tested
- Ischemic stroke TCM syndromes Diagnostic Scale, Meridian Energy Analysis Device
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ischemic stroke TCM syndromes Diagnostic ScaleOther
A scale for Chinese medical differentiation
Meridian Energy Analysis DeviceOther
A Device to assess involving meridian in certain diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Chinese medical syndromes differentiation by Ischemic stroke TCM syndromes Diagnostic Scale (ISTCMDS) in acute stroke patients
Measured: within 7 days from the onset of the stroke
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2015 (estimated)
- Study startMay 2015
- Primary completionMar 2016 (estimated)
- Study completionMar 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shu-chen Cheng, Study chair, Department of Traditional Chinese Medicine, Chang Gung Memorial Hospital at LinkouYEU-JHY CHANG, Study chair, Stroke Center and Department of Neurology, Chang Gung Memorial Hospital at Linkou
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02454166
- Sponsor's protocol ID
- 104-2081B
- Status last verified
- Apr 2015
- First submitted
- 22 May 2015
- Last updated
- 27 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Study of Chinese Medical Syndromes on Common Diseases: The Analysis of Chinese Medical Syndromes Differentiation on Acute Ischemic Stroke
- ClinicalTrials.gov ID
- NCT02454166
- Acronym / sponsor ID
- 104-2081B
- Conditions
- Ischemic Stroke
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Mar 2016 (estimated)
- Study completion
- Mar 2016 (estimated)
- First posted
- 27 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Acute ischemic stroke patients from Stroke Center at Linkou Chang Gung Memorial Hospital. The onset of stroke is set Within 7 days.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ischemic stroke TCM syndromes Diagnostic ScaleA scale for Chinese medical differentiation | Other | – |
| Meridian Energy Analysis DeviceA Device to assess involving meridian in certain diseases | Other | – |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shu-chen Cheng study chair
Department of Traditional Chinese Medicine, Chang Gung Memorial Hospital at Linkou
YEU-JHY CHANG study chair
Stroke Center and Department of Neurology, Chang Gung Memorial Hospital at Linkou
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemic Stroke, run by Chang Gung Memorial Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 May 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shu-chen Cheng (+886-3-3196200 ext. 2613, kkaren0330@yahoo.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2015.