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

Phase 4

Completed

• Conditions: Acute Ischemic Stroke
• Interventions: Drug: aspirin，chinese herbs；

• Registration Number: NCT00966316
• Lead Sponsor: Guangzhou University of Traditional Chinese Medicine

Brief Summary

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

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

Study Timeline

• Study Start: 2009-05
• Study First Submitted: 2009-08-25
• Study First Submitted QC: 2009-08-25
• Study First Posted: 2009-08-26
• Primary Completion: 2010-08
• Study Completion: 2011-01
• Status Verified: 2011-05
• Last Update Submitted: 2011-05-14
• Last Update Posted: 2011-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 314

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
pathway	aspirin，chinese herbs；	aspirin，Chinese herbs；acupuncture；rehabilitation；health education；

Primary Outcome Measures

Name	Time	Method
death rate；average hospital day；cost of hospitalization	3 months；discharge day

Secondary Outcome Measures

Name	Time	Method
Modified Rankin Scale (mRS) National Institute of Health Stroke Scale (NIHSS) Barthel Index degree of satisfaction	7 day；30 day；3 months

Trial Locations

Locations (1)

Guangdong Provincial Hospital of Chinese Medicine; 🇨🇳 Guangzhou, Guangdong, China