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

Primary Purpose

Cerebral Infarction

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Erigeron breviscapus injection
hua tuo zai zao wan (a herbal medicine pill)
Compound stroke herbal medicine (8 herbal)
Sponsored by
Guangzhou University of Traditional Chinese Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Infarction focused on measuring acute intracerebral infarction

Eligibility Criteria

40 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Dongzhimen Hospital of Beijing University of Traditional Chinese Medicine
  • Foshan Hospital of Traditional Chinese Medicine
  • 2nd hospital of Zhongshan University
  • Neurology Center, Guangdong Province Hospital of Tradtional Chinese Medicine
  • Zhongshan Hospital of Traditional Chinese Medicine
  • Ruikang Hospital of Traditional Chinese Medicine
  • 1st Hospital of Guangxi college of Traditional Chinese Medicine
  • The 1st Hospital of He'nan College of Traditional Chinese Medicine
  • The teahing hospital of Hubei College of Traditional Chinese Medicine
  • Taizhou Hospital of Traditional Chinese Medicine
  • Jinan Hospital of Traditional Chinese Medicine
  • Longhua Hospital of Shanghai University of Traditional Chinese Medicine
  • Shanghai Hospital of Traditional Chinese Medicine
  • Shuguang Hospital of Shanghai University of Traditional Chinese Medicine
  • Yueyang Hospital of Shanghai University of Traditional Chinese Medicine
  • zhongshan hospital of Fudan Unversity
  • Huashan Hospital of Fudan Unveristy
  • The Hosptial of Shanxi College of Traditional Chinese Medicine
  • The People's Hospital of Sichuan Province
  • Xinjiang Uygur Autonomous Region Hospital of Traditional Chinese Medicine
  • Zhejiang Province Hospital of Traditional Chinese Medicine
  • The 2nd Hospital of Wenzhou Medical College

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Chinese herbal medicine

placebo

Arm Description

Outcomes

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)

Full Information

First Posted
July 12, 2006
Last Updated
August 5, 2013
Sponsor
Guangzhou University of Traditional Chinese Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT00351806
Brief Title
AISTCM-Outcome Measurement of Acute Ischemic Stroke With Traditional Chinese Medicine
Official Title
AISTCM-The Pathological Pattern Differentiation and Outcome Measurement of Acute Ischemic Stroke Treated With Traditional Chinese Medicine
Study Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
July 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Guangzhou University of Traditional Chinese Medicine

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Infarction
Keywords
acute intracerebral infarction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
500 (false)

8. Arms, Groups, and Interventions

Arm Title
Chinese herbal medicine
Arm Type
Experimental
Arm Title
placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Erigeron breviscapus injection
Intervention Type
Drug
Intervention Name(s)
hua tuo zai zao wan (a herbal medicine pill)
Intervention Type
Drug
Intervention Name(s)
Compound stroke herbal medicine (8 herbal)
Primary Outcome Measure Information:
Title
death rate, Barthel Index
Secondary Outcome Measure Information:
Title
Glasgow Outcome Scale (GOS)
Title
Modified Rankin Scale (mRS)
Title
National Institute of Health Stroke Scale (NIHSS)
Title
Stroke Specific Quality of Life (SSQOL)
Title
Scale of Traditional Chinese Medicine (SSTCM)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Longhui Yang, Chairmam
Organizational Affiliation
Branch of Science and Education
Official's Role
Study Chair
Facility Information:
Facility Name
Dongzhimen Hospital of Beijing University of Traditional Chinese Medicine
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100700
Country
China
Facility Name
Foshan Hospital of Traditional Chinese Medicine
City
Foshan
State/Province
Guangdong
ZIP/Postal Code
528000
Country
China
Facility Name
2nd hospital of Zhongshan University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510120
Country
China
Facility Name
Neurology Center, Guangdong Province Hospital of Tradtional Chinese Medicine
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510120
Country
China
Facility Name
Zhongshan Hospital of Traditional Chinese Medicine
City
Zhongshan
State/Province
Guangdong
Country
China
Facility Name
Ruikang Hospital of Traditional Chinese Medicine
City
Nan Ning
State/Province
Guangxi
ZIP/Postal Code
530011
Country
China
Facility Name
1st Hospital of Guangxi college of Traditional Chinese Medicine
City
Nanning
State/Province
Guangxi
ZIP/Postal Code
530023
Country
China
Facility Name
The 1st Hospital of He'nan College of Traditional Chinese Medicine
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450006
Country
China
Facility Name
The teahing hospital of Hubei College of Traditional Chinese Medicine
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430006
Country
China
Facility Name
Taizhou Hospital of Traditional Chinese Medicine
City
Taizhou
State/Province
Jiangsu
Country
China
Facility Name
Jinan Hospital of Traditional Chinese Medicine
City
Jinan
State/Province
Shandong
Country
China
Facility Name
Longhua Hospital of Shanghai University of Traditional Chinese Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200000
Country
China
Facility Name
Shanghai Hospital of Traditional Chinese Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200000
Country
China
Facility Name
Shuguang Hospital of Shanghai University of Traditional Chinese Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200000
Country
China
Facility Name
Yueyang Hospital of Shanghai University of Traditional Chinese Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200000
Country
China
Facility Name
zhongshan hospital of Fudan Unversity
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Facility Name
Huashan Hospital of Fudan Unveristy
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200040
Country
China
Facility Name
The Hosptial of Shanxi College of Traditional Chinese Medicine
City
Xian yang
State/Province
Shanxi
ZIP/Postal Code
712000
Country
China
Facility Name
The People's Hospital of Sichuan Province
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610072
Country
China
Facility Name
Xinjiang Uygur Autonomous Region Hospital of Traditional Chinese Medicine
City
Urumqi
State/Province
Xinjiang
ZIP/Postal Code
830001
Country
China
Facility Name
Zhejiang Province Hospital of Traditional Chinese Medicine
City
Hangzhou
State/Province
Zhejiang
Country
China
Facility Name
The 2nd Hospital of Wenzhou Medical College
City
Wenzhou
State/Province
Zhejiang
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
20456839
Citation
Huang Y, Guo JW; Project Group for Demonstration Study of Syndrome Differentiation Protocol and Effect Evaluation of Acute Ischemic Stroke. Outcome and safety assessment of an herbal medicine treatment protocol for yin pattern of acute ischemic stroke. Zhong Xi Yi Jie He Xue Bao. 2010 May;8(5):417-26. doi: 10.3736/jcim20100504.
Results Reference
derived

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

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