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

May 14, 2011 updated by: Guangzhou University of Traditional Chinese Medicine
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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

314

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510120
        • Guangdong Provincial Hospital of Chinese Medicine

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

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 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

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: pathway
aspirin，Chinese herbs；acupuncture；rehabilitation；health education；
Drug: aspirin，chinese herbs；
aspirin 300mg/100mg,qd,chinese herbs, one dose ，qd
Other Names:
  • Bayer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
death rate；average hospital day；cost of hospitalization
Time Frame: 3 months；discharge day
3 months；discharge day

Secondary Outcome Measures

Outcome Measure
Time Frame
Modified Rankin Scale (mRS) National Institute of Health Stroke Scale (NIHSS) Barthel Index degree of satisfaction
Time Frame: 7 day；30 day；3 months
7 day；30 day；3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guangzhou University of Traditional Chinese Medicine

Investigators

  • Study Chair: yefeng cai, postgraduate, Guangdong Provincial Hospital of Traditional Chinese Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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, 2009

Primary Completion (Actual)

August 1, 2010

Study Completion (Actual)

January 1, 2011

Study Registration Dates

First Submitted

August 25, 2009

First Submitted That Met QC Criteria

August 25, 2009

First Posted (Estimate)

August 26, 2009

Study Record Updates

Last Update Posted (Estimate)

May 17, 2011

Last Update Submitted That Met QC Criteria

May 14, 2011

Last Verified

May 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 200707004

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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