Efficacy and Safety of Salvianolic Acid on AIS

Study Overview
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Brief Summary
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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.

Official Title
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Efficacy and Safety of Salvianolic Acid on Acute Ischemic Stroke

Conditions
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Stroke

Intervention / Treatment
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* Drug: Salvianolic Acid
* Drug: 0.9% NaCl


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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; CT examination to rule out cerebral hemorrhage; With clear signs of nervous system positioning, the National Institutes of Health Stroke Scale (NIHSS) score ≥ 4 Exclusion Criteria: Diseases with bleeding tendency; Liver and kidney dysfunction; Malignant tumors or those undergoing anti-tumor treatment; Allergic physique, allergic to aspirin or Salvianolic Acid; Heart failure, multiple system failure; Pregnant or breastfeeding women

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: salvianolic acid group<br>salvianolic acid group 100mg+0.9%NaCl 250ml, injection, 14 days | Drug: Salvianolic Acid<br>* salvianolic acid, injection, 100mg+0.9%NaCl 250ml, qd, 14 days<br>|
| Placebo Comparator: 0.9% NaCl<br>0.9%NaCl 250ml, injection, 14 days | Drug: 0.9% NaCl<br>* 0.9% NaCl<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MRS score | MRS score ≤2 | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cerebral blood flow volume (CBV) | Cerebral blood flow volume | 90 days | 
| Cerebral blood flow (CBF) | Cerebral blood flow | 90 days | 
| NIHSS score | NIHSS score | 90 days | 
| Adverse drug reactions (ADR) | Adverse drug reactions | 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stroke, ischemic, Acute