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

August 5, 2013 updated by: Guangzhou University of 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

500

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100700
        • Dongzhimen Hospital of Beijing University of Traditional Chinese Medicine
    • Guangdong
      • Foshan, Guangdong, China, 528000
        • Foshan Hospital of Traditional Chinese Medicine
      • Guangzhou, Guangdong, China, 510120
        • 2nd hospital of Zhongshan University
      • Guangzhou, Guangdong, China, 510120
        • Neurology Center, Guangdong Province Hospital of Tradtional Chinese Medicine
      • Zhongshan, Guangdong, China
        • Zhongshan Hospital of Traditional Chinese Medicine
    • Guangxi
      • Nan Ning, Guangxi, China, 530011
        • Ruikang Hospital of Traditional Chinese Medicine
      • Nanning, Guangxi, China, 530023
        • 1st Hospital of Guangxi college of Traditional Chinese Medicine
    • Henan
      • Zhengzhou, Henan, China, 450006
        • The 1st Hospital of He'nan College of Traditional Chinese Medicine
    • Hubei
      • Wuhan, Hubei, China, 430006
        • The teahing hospital of Hubei College of Traditional Chinese Medicine
    • Jiangsu
      • Taizhou, Jiangsu, China
        • Taizhou Hospital of Traditional Chinese Medicine
    • Shandong
      • Jinan, Shandong, China
        • Jinan hospital of traditional Chinese Medicine
    • Shanghai
      • 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
        • Shuguang hospital of Shanghai university of traditional Chinese medicine
      • Shanghai, Shanghai, China, 200000
        • Yueyang Hospital of Shanghai University of Traditional Chinese Medicine
      • Shanghai, Shanghai, China, 200032
        • zhongshan hospital of Fudan Unversity
      • Shanghai, Shanghai, China, 200040
        • Huashan Hospital of Fudan Unveristy
    • Shanxi
      • Xian yang, Shanxi, China, 712000
        • The Hosptial of Shanxi College of Traditional Chinese Medicine
    • Sichuan
      • Chengdu, Sichuan, China, 610072
        • The People's Hospital of Sichuan Province
    • Xinjiang
      • Urumqi, Xinjiang, China, 830001
        • Xinjiang Uygur Autonomous Region Hospital of Traditional Chinese Medicine
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • Zhejiang Province Hospital of Traditional Chinese Medicine
      • Wenzhou, Zhejiang, China
        • The 2nd Hospital of Wenzhou Medical College

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: placebo
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
death rate, Barthel Index

Secondary Outcome Measures

Outcome Measure
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guangzhou University of Traditional Chinese Medicine

Investigators

  • Study Chair: Longhui Yang, Chairmam, Branch of Science and Education

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2005

Study Completion

November 1, 2006

Study Registration Dates

First Submitted

July 12, 2006

First Submitted That Met QC Criteria

July 12, 2006

First Posted (Estimate)

July 13, 2006

Study Record Updates

Last Update Posted (Estimate)

August 7, 2013

Last Update Submitted That Met QC Criteria

August 5, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2004BA721A02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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