Efficacy and Safety of Salvianolic Acid on AIS

Not Applicable

Terminated

• Conditions: Stroke
• Interventions: Drug: Salvianolic Acid; Drug: 0.9% NaCl

• Registration Number: NCT04931628
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-06-14
• Study First Submitted QC: 2021-06-17
• Study First Posted: 2021-06-18
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-02
• Study Start: 2023-02-03
• Primary Completion: 2023-02-03
• Study Completion: 2023-02-03
• Last Update Posted: 2023-02-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
salvianolic acid group	Salvianolic Acid	salvianolic acid group 100mg+0.9%NaCl 250ml, injection, 14 days
0.9% NaCl	0.9% NaCl	0.9%NaCl 250ml, injection, 14 days

Primary Outcome Measures

Name	Time	Method
MRS score	90 days	MRS score ≤2

Secondary Outcome Measures

Name	Time	Method
NIHSS score	90 days	NIHSS score
Cerebral blood flow volume (CBV)	90 days	Cerebral blood flow volume
Cerebral blood flow (CBF)	90 days	Cerebral blood flow
Adverse drug reactions (ADR)	90 days	Adverse drug reactions

Trial Locations

Locations (1)

Dai Haibin; 🇨🇳 Hangzhou, Zhejiang, China