Establishment and Evaluation to the Effects of a Clinical Pathway for Acute Ischemic Stroke

NCT ID: NCT00966316

Last Updated: 2011-05-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

314 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-31

Study Completion Date

2011-01-31

Brief Summary

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The purpose of this study is to determine whether the clinical pathway for acute ischemic stroke(with combination of traditional Chinese medicine and western medicine) is able to improve the outcome of acute ischemic stroke and evaluate its effect on hospital day and cost, etc. Meanwhile, the study will discuss the safety and efficiency of this kind of Clinical Pathway

Detailed Description

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Eligibility Ages Eligible for Study: 18 Years to 85 Years Genders Eligible for Study: Both Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

Those clinically diagnosed with acute ischemic stroke ; 18-85 years old; Over 6 hours and within 14 days from onset 4\<=NIHSS \<=22; Informed consent signed by patient or his/her family ;

Exclusion Criteria:

Hemorrhagic stroke; Cerebral hernia; Serious heart, liver, lung, kidney functional failure,malignancy; Not cooperative with physician; Psychological disorder; Already taken part in other clinical drug trial within the past 3 months

Conditions

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Acute Ischemic Stroke

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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pathway

aspirin,Chinese herbs;acupuncture;rehabilitation;health education;

Group Type EXPERIMENTAL

aspirin,chinese herbs;

Intervention Type DRUG

aspirin 300mg/100mg,qd,chinese herbs, one dose ,qd

Interventions

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aspirin,chinese herbs;

aspirin 300mg/100mg,qd,chinese herbs, one dose ,qd

Intervention Type DRUG

Other Intervention Names

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Bayer

Eligibility Criteria

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Inclusion Criteria

* Ischemic stroke diagnosed with both criteria of traditional Chinese medicine and western medicine;
* 18-85 years old;
* Over 6 hours and within 14 days from onset
* 4\<=NIHSS \<=22;
* Informed consent signed by patient or his/her family ;

Exclusion Criteria

* Hemorrhagic stroke;
* Cerebral hernia;
* Serious heart, liver, lung, kidney functional failure,malignancy;
* Not cooperative with physician;
* Psychological disorder;
* Already taken part in other clinical drug trial within the past 3 months
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Guangzhou University of Traditional Chinese Medicine

OTHER

Sponsor Role lead

Responsible Party

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Guangdong Provincial Hospital of Chinese Medicine

Principal Investigators

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yefeng cai, postgraduate

Role: STUDY_CHAIR

Guangdong Provincial Hospital of Traditional Chinese Medicine

Locations

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Guangdong Provincial Hospital of Chinese Medicine

Guangzhou, Guangdong, China

Site Status

Countries

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China

References

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Adams HP Jr, del Zoppo G, Alberts MJ, Bhatt DL, Brass L, Furlan A, Grubb RL, Higashida RT, Jauch EC, Kidwell C, Lyden PD, Morgenstern LB, Qureshi AI, Rosenwasser RH, Scott PA, Wijdicks EF; American Heart Association/American Stroke Association Stroke Council; American Heart Association/American Stroke Association Clinical Cardiology Council; American Heart Association/American Stroke Association Cardiovascular Radiology and Intervention Council; Atherosclerotic Peripheral Vascular Disease Working Group; Quality of Care Outcomes in Research Interdisciplinary Working Group. Guidelines for the early management of adults with ischemic stroke: a guideline from the American Heart Association/American Stroke Association Stroke Council, Clinical Cardiology Council, Cardiovascular Radiology and Intervention Council, and the Atherosclerotic Peripheral Vascular Disease and Quality of Care Outcomes in Research Interdisciplinary Working Groups: The American Academy of Neurology affirms the value of this guideline as an educational tool for neurologists. Circulation. 2007 May 22;115(20):e478-534. doi: 10.1161/CIRCULATIONAHA.107.181486.

Reference Type RESULT
PMID: 17515473 (View on PubMed)

Related Links

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Other Identifiers

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200707004

Identifier Type: -

Identifier Source: org_study_id

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