ischemic stroke
Conditions
Interventions
Test group:Yiqi Fumai for injection (lyophilized) (0.65g/ bottle) 8 bottles added to conventional therapies
Control group:0.9% NaClinjection added to conventional therapies
Sponsors
Dongzhimen Hospital, Beijing University of Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Diagnosed as acute ischemic stroke; 2. Diagnosed as large artery atherosclerosis stroke according to TOAST classification; 3. Acute ischemic stroke within 48 hours of symptom onset; 4. 18-80 years old; 5. National Institutes of Health Stroke Scale score 4-18 points; 6. The average of systolic blood pressure (at least 3 times) measured before the enrollment=155mmHg; 7. Patient or legally authorized representative has signed informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients who have already received intravenous thrombolysis or endovascular treatment; 2. Posterior circulation infarction; 3. Secondary stroke caused by tumors; 4. Previous history of stroke and mRS = 2 points before the onset of this stroke; 5. NIHSS 1a >2 points; 6.Patients with yellow and greasy tongue fur; 7. Patients with other diseases that render the evaluation of neurological function or follow-up; 8. Patients with significant hepatic or renal insufficiency (defined as a serum creatinine concentration, alanine aminotransferase, or aspartate aminotransferase value that is twice greater than the upper limit of normal); 9. Suffering from other serious life-threatening diseases with an expected survival time of less than 3 months; 10. Known to be pregnant, planning to be pregnant, or breastfeeding; 11. Currently participating in other interventional clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of patients with favorable functional outcomes (mRS=2) ; | — |
Secondary
| Measure | Time frame |
|---|---|
| proportion of NIHSS score increased by >= 2 points;The proportion of patients with mRS=3,mRS=1;The change value of TCM syndrome efficacy, total score and individual score compared with baseline;Barthel index score;MMSE score;Proportion of patients with new cerebrovascular events; | — |
Countries
China
Contacts
Public ContactKegang Cao
Dongzhimen Hospital, Beijing University of Chinese Medicine,
Outcome results
None listed