Efficacy and Safety of Salvianolic Acid on AIS

Zhejiang University

Status: Terminated

Conditions: Stroke

Treatments: Drug: 0.9% NaCl; Drug: Salvianolic Acid

Study type: Interventional

Funder types: Other

Identifiers

NCT04931628

2017-092

Details and patient eligibility

About

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.

Enrollment: 1 patient

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1 participants in 2 patient groups, including a placebo group

salvianolic acid group

Active Comparator group

Description:

salvianolic acid group 100mg+0.9%NaCl 250ml, injection, 14 days

Treatment:

Drug: Salvianolic Acid

0.9% NaCl

Placebo Comparator group

Description:

0.9%NaCl 250ml, injection, 14 days

Treatment:

Drug: 0.9% NaCl