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AISTCM-Outcome Measurement of Acute Ischemic Stroke With Traditional Chinese Medicine

This study has been completed.
Sponsor:
Information provided by:
Guangzhou University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier:
NCT00351806
First received: July 12, 2006
Last updated: June 20, 2009
Last verified: June 2006
History of Changes

July 12, 2006
June 20, 2009
July 2005
Not Provided
death rate, Barthel Index
death rate, Barthal Index
Complete list of historical versions of study NCT00351806 on ClinicalTrials.gov Archive Site
  • Glasgow Outcome Scale (GOS)
  • Modified Rankin Scale (mRS)
  • National Institute of Health Stroke Scale (NIHSS)
  • Stroke Specific Quality of Life (SSQOL)
  • Scale of Traditional Chinese Medicine (SSTCM)
  • Glowsger outcome scale(GOS), Modified rankin scale(mRS), National Institute of Health stroke Scale(NIHSS),
  • stroke special quality of life (SSQOL), scale of traditional Chinese Medicine
Not Provided
Not Provided
 
AISTCM-Outcome Measurement of Acute Ischemic Stroke With Traditional Chinese Medicine
AISTCM-The Pathological Pattern Differentiation and Outcome Measurement of Acute Ischemic Stroke Treated With Traditional Chinese Medicine

The purpose of this study is to determine whether Traditional Chinese Medicine (TCM) is able to improve the outcome of acute ischemic stroke and to observe its safety.

The purpose of this study is to determine whether Traditional Chinese Medicine (TCM) is able to improve the outcome of acute ischemic stroke and safety.
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Cerebral Infarction
  • Drug: Erigeron breviscapus injection
  • Drug: hua tuo zai zao wan (a herbal medicine pill)
  • Drug: Compound stroke herbal medicine (8 herbal)
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
500
November 2006
Not Provided

Inclusion Criteria:

  • Ischemic stroke diagnosis by CT/MRI scan
  • Yin pattern of Traditional Chinese Medicine Theory
  • 40-85 years old
  • Total anterior circulation infarcts (TACI), partial anterior territory cerebral infarction (PACI), lacunar anterior circulation infarcts (LACI) type under Oxfordshire Community Stroke Project (OCSP) standard
  • NIHSS >=4;
  • Glasgow coma scale (GCS) >=7;
  • Modified Rankin Scale less than 2 degrees before onset of this stroke
  • Informed consent signed by patient or his/her family

Exclusion Criteria:

  • Hemorrhagic stroke;
  • Coma, GCS<=7;
  • Cerebral hernia;
  • Serious heart, liver, lung, kidney functional failure;
  • Gastrointestinal (GI) bleeding;
  • Thrombolysis drugs or surgery was administrated to the patient;
  • Not cooperative with physician;
  • Psychological disorder;
  • Already taken part in other clinical drug trial within the past 3 months
Both
40 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT00351806
2004BA721A02
Not Provided
Not Provided
Guangzhou University of Traditional Chinese Medicine
Not Provided
Study Chair: Longhui Yang, Chairmam Branch of Science and Education
Guangzhou University of Traditional Chinese Medicine
June 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP