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

AISTCM-The Pathological Pattern Differentiation and Outcome Measurement of Acute Ischemic Stroke Treated With Traditional Chinese Medicine

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00351806

Enrollment

500

Registered

2006-07-13

Start date

2005-07-31

Completion date

2006-11-30

Last updated

2013-08-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebral Infarction

Keywords

acute intracerebral infarction

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.

Interventions

DRUGErigeron breviscapus injection

DRUGhua tuo zai zao wan (a herbal medicine pill)

DRUGCompound stroke herbal medicine (8 herbal)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE

Eligibility

Sex/Gender

ALL

Age

40 Years to 85 Years

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

Design outcomes

Primary

Measure	Time frame
death rate, Barthel Index	—

Secondary

Measure	Time frame
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)	—

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026