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

This study has been completed.
Sponsor:
Information provided by:
Guangzhou University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier:
NCT00966316
First received: August 25, 2009
Last updated: May 14, 2011
Last verified: May 2011
  Purpose

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


Condition Intervention Phase
Acute Ischemic Stroke
Drug: aspirin,chinese herbs;
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Establishment and Evaluation to the Effects of a Clinical Pathway for Acute Ischemic Stroke

Resource links provided by NLM:


Further study details as provided by Guangzhou University of Traditional Chinese Medicine:

Primary Outcome Measures:
  • death rate;average hospital day;cost of hospitalization [ Time Frame: 3 months;discharge day ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Modified Rankin Scale (mRS) National Institute of Health Stroke Scale (NIHSS) Barthel Index degree of satisfaction [ Time Frame: 7 day;30 day;3 months ] [ Designated as safety issue: No ]

Enrollment: 314
Study Start Date: May 2009
Study Completion Date: January 2011
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: pathway
aspirin,Chinese herbs;acupuncture;rehabilitation;health education;
Drug: aspirin,chinese herbs;
aspirin 300mg/100mg,qd,chinese herbs, one dose ,qd
Other Name: Bayer

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

  Eligibility

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00966316

Locations
China, Guangdong
Guangdong Provincial Hospital of Chinese Medicine
Guangzhou, Guangdong, China, 510120
Sponsors and Collaborators
Guangzhou University of Traditional Chinese Medicine
Investigators
Study Chair: yefeng cai, postgraduate Guangdong Provincial Hospital of Traditional Chinese Medicine
  More Information

Additional Information:
Publications:
Responsible Party: Yefeng,Cai, Guangdong Provincial Hospital of Chinese Medicine
ClinicalTrials.gov Identifier: NCT00966316     History of Changes
Other Study ID Numbers: 200707004
Study First Received: August 25, 2009
Last Updated: May 14, 2011
Health Authority: China: Food and Drug Administration

Keywords provided by Guangzhou University of Traditional Chinese Medicine:
Acute Ischemic Stroke;clinical pathway;TCM;

Additional relevant MeSH terms:
Ischemia
Stroke
Cerebral Infarction
Pathologic Processes
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia
Aspirin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors

ClinicalTrials.gov processed this record on July 22, 2014