Stroke
Conditions
Keywords
Stroke, ischemic, Acute
Brief summary
Stroke has the characteristics of high morbidity, disability and fatality rate, which brings heavy spiritual and economic burdens to the family, society and the country. In my country, 33%-50% of ischemic strokes are attributed to intracranial atherosclerosis. Studies have shown that oxidative stress, increased blood viscosity, and damage to vascular endothelial cells are important mechanisms for the development of cerebral infarction. Salvia miltiorrhiza is a commonly used traditional Chinese medicine in traditional medicine in my country. Salvia miltiorrhiza polyphenolic acid is the effective ingredient of salvia miltiorrhiza. It is the water-soluble active part of salvia miltiorrhiza. It can resist oxidation, anticoagulation, antiplatelet, cell protection, and expand blood vessels, thereby achieving protection Cardiovascular system. The purpose of this study was to evaluate the effects and adverse effects of salvianolic acid on acute ischemic stroke onset within 72 hours, and to evaluate the improvement of patients' ischemic area perfusion and clinical function scores.
Interventions
DRUGSalvianolic Acid
salvianolic acid, injection, 100mg+0.9%NaCl 250ml, qd, 14 days
DRUG0.9% NaCl
0.9% NaCl
Sponsors
First Affiliated Hospital of Wenzhou Medical University
Second Affiliated Hospital of Wenzhou Medical University
Zhejiang University
Ningbo No. 1 Hospital
Zhejiang Hospital
Zhejiang Provincial Tongde Hospital
The First Affiliated Hospital of Zhejiang Chinese Medical University
Xiaoshan People's Hospital
Red Cross Hospital, Hangzhou, China
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Acute ischemic stroke with the first onset, or a history of cerebral infarction but with a modified Rankin Scale (mRS) score ≤1, onset within 72h; 2. CT examination to rule out cerebral hemorrhage; 3. With clear signs of nervous system positioning, the National Institutes of Health Stroke Scale (NIHSS) score ≥ 4
Exclusion criteria
1. Diseases with bleeding tendency; 2. Liver and kidney dysfunction; 3. Malignant tumors or those undergoing anti-tumor treatment; 4. Allergic physique, allergic to aspirin or Salvianolic Acid; 5. Heart failure, multiple system failure; 6. Pregnant or breastfeeding women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| MRS score | 90 days | MRS score ≤2 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cerebral blood flow volume (CBV) | 90 days | Cerebral blood flow volume |
| Cerebral blood flow (CBF) | 90 days | Cerebral blood flow |
| NIHSS score | 90 days | NIHSS score |
| Adverse drug reactions (ADR) | 90 days | Adverse drug reactions |
Countries
China
Outcome results
None listed