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

Completed

Phase 4 Results N/A

Trial Description

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

Conditions

Interventions

  • Aspirin,chinese herbs; Drug
    Other Names: Bayer
    Intervention Desc: aspirin 300mg/100mg,qd,chinese herbs, one dose ,qd
    ARM 1: Kind: Experimental
    Label: pathway
    Description: aspirin?Chinese herbs?acupuncture?rehabilitation?health education?

Trial Design

  • Allocation: Non-Randomized
  • Masking: Open Label
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary death rate;average hospital day;cost of hospitalization 3 months;discharge day No
Secondary Modified Rankin Scale (mRS) National Institute of Health Stroke Scale (NIHSS) Barthel Index degree of satisfaction 7 day;30 day;3 months No

Sponsors