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Completed

NCT Number: NCT00966316

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

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

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Key information

Conditions

Acute Ischemic Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Ischemic Stroke Nervous System Diseases Stroke Vascular Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Guangdong Provincial Hospital of Chinese Medicine

Guangzhou, Guangdong, 510120, China

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

aspirin，chinese herbs；

Drug

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

Other names: Bayer

Primary outcomes

  1. death rate；average hospital day；cost of hospitalization

    Time frame: 3 months；discharge day

Secondary outcomes

  1. Modified Rankin Scale (mRS) National Institute of Health Stroke Scale (NIHSS) Barthel Index degree of satisfaction

    Time frame: 7 day；30 day；3 months

Sponsors and collaborators

Lead sponsor

Guangzhou University of Traditional Chinese Medicine

Other

Registry information

Acronym: PAIS

Important dates

Study start
2009
Primary completion
2010
Study completion
2011
First posted
Aug 26, 2009
Registry last updated
May 17, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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