AISTCM
Outcome Measurement of Acute Ischemic Stroke With Traditional Chinese Medicine
|
Status:
Ongoing. Trial began in July 2005 and completed in December 2006 with 606 cases.
Purpose:
To determine if the use of Traditional Chinese Medicine (TCM) is able to improve the outcome of acute ischemic stroke and to observe its safety.
Year Started:
2005
Year Finished:
2006
Design:
Interventional, randomized, single blind, placebo control, parallel assignment, safety/efficacy study.
Inclusion Criteria
Ischemic stroke diagnosis by CT/MRI scan; yin pattern of Traditional Chinese Medicine Theory; 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.
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.
Patient Involvement:
Patients take medication and return for follow-up as instructed.
Primary Outcome:
Mortality rate, Barthel Index.
Secondary Outcome:
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).
Results:
The baseline characters of are comparable Between Group A and Group B (P＞0.05). 5 cases died in Group A and 7 cases died in Group B, which had no significant difference, (P＞0.05); Compared with the group B, the neurological deficit score (National Institute of Health Stroke Scale, NIHSS) determined on the 21st day after treatment was ameliorated in the treatment group (P<0.05). Moreover, the 90-day followup showed that the severe disability rate was lower (BI<75，20％VS 26.3% ) (P<0.01), the complete rehabilitation and mild disability rate (mRS 0－1，59.3%Vs 67.9%) were higher（P<0.05）in the Group A than those in the Group B . 76 cases of adverse reaction/events happened; which manifested as digestive symptom, skin action, bleeding tendency and aminopherase higher, but had no statistical difference in two groups.
Conclusion The HMP used in this study may improve neural function of patients in 21 days, and reduce the severe disability rate in those after 90 days’ treatment, with little noncorrelation adverse reaction with HMP.
|
Source of Information:
ClinicalTrials.gov
|
Web Links and Publications:
|
|
This information last updated on: 5/28/2008
Reviewed on: 10/19/2009.
|
Trials
Directories