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

Phase 4
Completed
Conditions
Cerebral Infarction
Interventions
Drug: Erigeron breviscapus injection
Drug: hua tuo zai zao wan (a herbal medicine pill)
Drug: Compound stroke herbal medicine (8 herbal)
Registration Number
NCT00351806
Lead Sponsor
Guangzhou University of Traditional Chinese Medicine
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
500
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 & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Chinese herbal medicineErigeron breviscapus injection-
Chinese herbal medicinehua tuo zai zao wan (a herbal medicine pill)-
Chinese herbal medicineCompound stroke herbal medicine (8 herbal)-
Primary Outcome Measures
NameTimeMethod
death rate, Barthel Index
Secondary Outcome Measures
NameTimeMethod
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)

Trial Locations

Locations (22)

Foshan Hospital of Traditional Chinese Medicine

🇨🇳

Foshan, Guangdong, China

2nd hospital of Zhongshan University

🇨🇳

Guangzhou, Guangdong, China

Yueyang Hospital of Shanghai University of Traditional Chinese Medicine

🇨🇳

Shanghai, Shanghai, China

zhongshan hospital of Fudan Unversity

🇨🇳

Shanghai, Shanghai, China

Ruikang Hospital of Traditional Chinese Medicine

🇨🇳

Nan Ning, Guangxi, China

Neurology Center, Guangdong Province Hospital of Tradtional Chinese Medicine

🇨🇳

Guangzhou, Guangdong, China

1st Hospital of Guangxi college of Traditional Chinese Medicine

🇨🇳

Nanning, Guangxi, China

Taizhou Hospital of Traditional Chinese Medicine

🇨🇳

Taizhou, Jiangsu, China

Jinan Hospital of Traditional Chinese Medicine

🇨🇳

Jinan, Shandong, China

The Hosptial of Shanxi College of Traditional Chinese Medicine

🇨🇳

Xian yang, Shanxi, China

The People's Hospital of Sichuan Province

🇨🇳

Chengdu, Sichuan, China

Xinjiang Uygur Autonomous Region Hospital of Traditional Chinese Medicine

🇨🇳

Urumqi, Xinjiang, China

Longhua Hospital of Shanghai University of Traditional Chinese Medicine

🇨🇳

Shanghai, Shanghai, China

The 2nd Hospital of Wenzhou Medical College

🇨🇳

Wenzhou, Zhejiang, China

Huashan Hospital of Fudan Unveristy

🇨🇳

Shanghai, Shanghai, China

Zhejiang Province Hospital of Traditional Chinese Medicine

🇨🇳

Hangzhou, Zhejiang, China

The 1st Hospital of He'nan College of Traditional Chinese Medicine

🇨🇳

Zhengzhou, Henan, China

The teahing hospital of Hubei College of Traditional Chinese Medicine

🇨🇳

Wuhan, Hubei, China

Shanghai Hospital of Traditional Chinese Medicine

🇨🇳

Shanghai, Shanghai, China

Shuguang Hospital of Shanghai University of Traditional Chinese Medicine

🇨🇳

Shanghai, Shanghai, China

Dongzhimen Hospital of Beijing University of Traditional Chinese Medicine

🇨🇳

Beijing, Beijing, China

Zhongshan Hospital of Traditional Chinese Medicine

🇨🇳

Zhongshan, Guangdong, China

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