Stroke Clinical Trial
Official title:
Efficacy and Safety of Salvianolic Acid on Acute Ischemic Stroke
Verified date | February 2023 |
Source | Second Affiliated Hospital, School of Medicine, Zhejiang University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 1 |
Est. completion date | February 3, 2023 |
Est. primary completion date | February 3, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
China | Dai Haibin | Hangzhou | Zhejiang |
Lead Sponsor | Collaborator |
---|---|
Second Affiliated Hospital, School of Medicine, Zhejiang University | First Affiliated Hospital of Wenzhou Medical University, Ningbo No. 1 Hospital, Red Cross Hospital, Hangzhou, China, Second Affiliated Hospital of Wenzhou Medical University, The First Affiliated Hospital of Zhejiang Chinese Medical University, Xiaoshan People's Hospital, Zhejiang Hospital, Zhejiang Provincial Tongde Hospital, Zhejiang University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | MRS score | MRS score =2 | 90 days | |
Secondary | Cerebral blood flow volume (CBV) | Cerebral blood flow volume | 90 days | |
Secondary | Cerebral blood flow (CBF) | Cerebral blood flow | 90 days | |
Secondary | NIHSS score | NIHSS score | 90 days | |
Secondary | Adverse drug reactions (ADR) | Adverse drug reactions | 90 days |
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