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: August 5, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention Phase
Cerebral Infarction
Drug: Erigeron breviscapus injection
Drug: hua tuo zai zao wan (a herbal medicine pill)
Drug: Compound stroke herbal medicine (8 herbal)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: AISTCM-The Pathological Pattern Differentiation and Outcome Measurement of Acute Ischemic Stroke Treated With Traditional Chinese Medicine

Resource links provided by NLM:


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

Primary Outcome Measures:
  • death rate, Barthel Index

Secondary Outcome Measures:
  • 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)

Estimated Enrollment: 500
Study Start Date: July 2005
Estimated Study Completion Date: November 2006
Arms Assigned Interventions
Experimental: Chinese herbal medicine Drug: Erigeron breviscapus injection Drug: hua tuo zai zao wan (a herbal medicine pill) Drug: Compound stroke herbal medicine (8 herbal)
Placebo Comparator: placebo

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   40 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT00351806

Locations
China, Beijing
Dongzhimen Hospital of Beijing University of Traditional Chinese Medicine
Beijing, Beijing, China, 100700
China, Guangdong
Foshan Hospital of Traditional Chinese Medicine
Foshan, Guangdong, China, 528000
2nd hospital of Zhongshan University
Guangzhou, Guangdong, China, 510120
Neurology Center, Guangdong Province Hospital of Tradtional Chinese Medicine
Guangzhou, Guangdong, China, 510120
Zhongshan Hospital of Traditional Chinese Medicine
Zhongshan, Guangdong, China
China, Guangxi
Ruikang Hospital of Traditional Chinese Medicine
Nan Ning, Guangxi, China, 530011
1st Hospital of Guangxi college of Traditional Chinese Medicine
Nanning, Guangxi, China, 530023
China, Henan
The 1st Hospital of He'nan College of Traditional Chinese Medicine
Zhengzhou, Henan, China, 450006
China, Hubei
The teahing hospital of Hubei College of Traditional Chinese Medicine
Wuhan, Hubei, China, 430006
China, Jiangsu
Taizhou Hospital of Traditional Chinese Medicine
Taizhou, Jiangsu, China
China, Shandong
Jinan Hospital of Traditional Chinese Medicine
Jinan, Shandong, China
China, Shanghai
Shuguang Hospital of Shanghai University of Traditional Chinese Medicine
Shanghai, Shanghai, China, 200000
Huashan Hospital of Fudan Unveristy
Shanghai, Shanghai, China, 200040
zhongshan hospital of Fudan Unversity
Shanghai, Shanghai, China, 200032
Yueyang Hospital of Shanghai University of Traditional Chinese Medicine
Shanghai, Shanghai, China, 200000
Longhua Hospital of Shanghai University of Traditional Chinese Medicine
Shanghai, Shanghai, China, 200000
Shanghai Hospital of Traditional Chinese Medicine
Shanghai, Shanghai, China, 200000
China, Shanxi
The Hosptial of Shanxi College of Traditional Chinese Medicine
Xian yang, Shanxi, China, 712000
China, Sichuan
The People's Hospital of Sichuan Province
Chengdu, Sichuan, China, 610072
China, Xinjiang
Xinjiang Uygur Autonomous Region Hospital of Traditional Chinese Medicine
Urumqi, Xinjiang, China, 830001
China, Zhejiang
Zhejiang Province Hospital of Traditional Chinese Medicine
Hangzhou, Zhejiang, China
The 2nd Hospital of Wenzhou Medical College
Wenzhou, Zhejiang, China
Sponsors and Collaborators
Guangzhou University of Traditional Chinese Medicine
Investigators
Study Chair: Longhui Yang, Chairmam Branch of Science and Education
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00351806     History of Changes
Other Study ID Numbers: 2004BA721A02
Study First Received: July 12, 2006
Last Updated: August 5, 2013
Health Authority: China: Ministry of Science & Technology (MOST) of the People's Republic of China

Keywords provided by Guangzhou University of Traditional Chinese Medicine:
acute intracerebral infarction

Additional relevant MeSH terms:
Infarction
Cerebral Infarction
Stroke
Ischemia
Pathologic Processes
Necrosis
Brain Infarction
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 16, 2014