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.

Study Timeline

• Study Start: 2005-07
• Study First Submitted: 2006-07-12
• Study First Submitted QC: 2006-07-12
• Study First Posted: 2006-07-13
• Study Completion: 2006-11
• Status Verified: 2013-08
• Last Update Submitted: 2013-08-05
• Last Update Posted: 2013-08-07

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

Group	Intervention	Description
Chinese herbal medicine	Erigeron breviscapus injection	-
Chinese herbal medicine	hua tuo zai zao wan (a herbal medicine pill)	-
Chinese herbal medicine	Compound stroke herbal medicine (8 herbal)	-

Primary Outcome Measures

Name	Time	Method
death rate, Barthel Index

Secondary Outcome Measures

Name	Time	Method
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)

Dongzhimen Hospital of Beijing University of Traditional Chinese Medicine; 🇨🇳 Beijing, Beijing, China

Foshan Hospital of Traditional Chinese Medicine; 🇨🇳 Foshan, Guangdong, China

2nd hospital of Zhongshan University; 🇨🇳 Guangzhou, Guangdong, China

Neurology Center, Guangdong Province Hospital of Tradtional Chinese Medicine; 🇨🇳 Guangzhou, Guangdong, China

Zhongshan Hospital of Traditional Chinese Medicine; 🇨🇳 Zhongshan, Guangdong, China

Ruikang Hospital of Traditional Chinese Medicine; 🇨🇳 Nan Ning, Guangxi, China

1st Hospital of Guangxi college of Traditional Chinese Medicine; 🇨🇳 Nanning, Guangxi, 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

Taizhou Hospital of Traditional Chinese Medicine; 🇨🇳 Taizhou, Jiangsu, China

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