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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-07-31

Study Completion Date

2006-11-30

Brief Summary

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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

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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.

Conditions

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Cerebral Infarction

Keywords

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acute intracerebral infarction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Study Groups

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Chinese herbal medicine

Group Type EXPERIMENTAL

Erigeron breviscapus injection

Intervention Type DRUG

hua tuo zai zao wan (a herbal medicine pill)

Intervention Type DRUG

Compound stroke herbal medicine (8 herbal)

Intervention Type DRUG

placebo

Group Type PLACEBO_COMPARATOR

No interventions assigned to this group

Interventions

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Erigeron breviscapus injection

Intervention Type DRUG

hua tuo zai zao wan (a herbal medicine pill)

Intervention Type DRUG

Compound stroke herbal medicine (8 herbal)

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Longhui Yang, Chairmam

Role: STUDY_CHAIR

Branch of Science and Education

Locations

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Dongzhimen Hospital of Beijing University of Traditional Chinese Medicine

Beijing, Beijing Municipality, China

Site Status

Foshan Hospital of Traditional Chinese Medicine

Foshan, Guangdong, China

Site Status

2nd hospital of Zhongshan University

Guangzhou, Guangdong, China

Site Status

Neurology Center, Guangdong Province Hospital of Tradtional Chinese Medicine

Guangzhou, Guangdong, China

Site Status

Zhongshan Hospital of Traditional Chinese Medicine

Zhongshan, Guangdong, China

Site Status

Ruikang Hospital of Traditional Chinese Medicine

Nanning, Guangxi, China

Site Status

1st Hospital of Guangxi college of Traditional Chinese Medicine

Nanning, Guangxi, China

Site Status

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

Zhengzhou, Henan, China

Site Status

The teahing hospital of Hubei College of Traditional Chinese Medicine

Wuhan, Hubei, China

Site Status

Taizhou Hospital of Traditional Chinese Medicine

Taizhou, Jiangsu, China

Site Status