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

Guangzhou University of Traditional Chinese Medicine

Status and phase: Completed; Phase 4

Conditions: Cerebral Infarction

Treatments: Drug: Compound stroke herbal medicine (8 herbal); Drug: Erigeron breviscapus injection; Drug: hua tuo zai zao wan (a herbal medicine pill)

Study type: Interventional

Funder types: Other

Identifiers

NCT00351806

2004BA721A02

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 40 to 85 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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500 participants in 2 patient groups, including a placebo group

Chinese herbal medicine

Experimental group

Treatment:

Drug: Compound stroke herbal medicine (8 herbal)

Drug: Erigeron breviscapus injection

Drug: hua tuo zai zao wan (a herbal medicine pill)

placebo

Placebo Comparator group