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

Guangzhou University of Traditional Chinese Medicine500 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

500

Conditions

Cerebral Infarction

Interventions

Erigeron breviscapus injectionDRUG

hua tuo zai zao wan (a herbal medicine pill)DRUG

Compound stroke herbal medicine (8 herbal)DRUG

Eligibility

Sex: ALLMin age: 40 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (22)

Outcomes

Primary Outcomes

death rate, Barthel Index

Secondary Outcomes

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)

Data from ClinicalTrials.gov

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