Small artery occlusive ischemic stroke
Conditions
Interventions
Experimental group:Western medicine basic treatment combined with Zhishe Tongluo Capsules
Control group :Basic Western Medicine Treatment
Sponsors
The First Affiliated Hospital of Henan University of TCM
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Meets the diagnostic criteria for acute ischemic stroke, with TOAST classification of small artery occlusive ischemic stroke; 2. Diagnosis of Qi deficiency and Blood stasis syndrome elements in accordance with the Diagnostic Scale for Ischemic Stroke Syndrome Elements; 3. Within 72 hours of onset; 4. 18 years old = 7.0%; 6. Voluntarily sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. MRS score >= 2 points before enrollment; 2. Patients with a history of severe mental illness or dementia who are unable to cooperate with the study; 3. History of coagulation disorders, systemic bleeding, previous history of coagulation disorders or systemic bleeding, previous history of thrombocytopenia or neutropenia; 4. Individuals with abnormal liver and kidney function (serum ALT>2 × ULN, serum Cr>1.5 × ULN); 5. Pregnant, pregnant, or breastfeeding women; 6. Merge life-threatening serious illnesses with an estimated survival period of less than 12 months; 7. Individuals who have participated in other drug trials within the past 3 months prior to enrollment; 8. Clearly allergic to Zhishe Tongluo Capsules.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of composite vascular events occurring within one year after randomization; | — |
Secondary
| Measure | Time frame |
|---|---|
| The proportion of early neurological deterioration (NIHSS score increase >= 4 points or NIHSS motor score increase >= 1 point) within 7 days after randomization;The proportion of good functional outcomes at 90 days, 180 days, and 1 year after randomization (mRS score 0-1), MoCA score, QOL score, HADS score;One year after randomization, Fazekas grading and glycated hemoglobin levels;The proportion of stroke, non fatal myocardial infarction, emergency coronary revascularization, all-cause mortality, and TIA events occurring one year after randomization; | — |
Countries
China
Contacts
Public ContactZhao Min
The First Affiliated Hospital of Henan University of TCM
Outcome results
None listed