Study on the Effectiveness and Safety of Shuxinin Injection in the Treatment of Acute Ischemic Stroke

Acute Ischemic Stroke Clinical Trial

Official title: A Randomized, Double-blind, Placebo-parallel-controlled, Multicenter Clinical Trial of the Efficacy and Safety of Shuxinin Injection in the Treatment of Acute Ischemic Stroke

Status Recruiting

Clinical Trial Summary

This is a randomized, double-blind, placebo-parallel-controlled multiplier designed to observe and evaluate the efficacy and safety of Shuxuening injection in the treatment of acute ischemic stroke for 10 days and continue follow-up to 90 days after the onset of the disease.

Clinical Trial Description

Cerebral infarction (CI), also known as ischemic stroke, refers to the softening and necrosis of local brain tissue due to blood circulation disorders, ischemia, and hypoxia. According to the 2016 Stroke Epidemiology Report [4], there are currently 70 million stroke patients in my country, 2 million new strokes occur each year, and 1.65 million deaths due to stroke each year. There is one Chinese every 12 seconds. Stroke occurs, and one Chinese person dies of a stroke every 21 seconds. Chinese people who die from a stroke each year account for 22.45% of all deaths. According to the results of the study on the incidence and mortality of stroke in the Chinese population, stroke is currently the number one cause of death in China, accounting for 20% of deaths in urban populations and 19% in rural areas. Cerebral infarction is a disease with high morbidity, high disability, high mortality and high recurrence rate in China, and it has gradually attracted widespread attention from the whole society. Shuxuening injection is developed by Shiyao Yinhu Pharmaceutical Co., Ltd., and is a sterile aqueous solution made of ginkgo biloba or ginkgo biloba extract. The auxiliary materials are ethanol and vitamin C. Its main function is to expand blood vessels and improve microcirculation. It is used for ischemic cardiovascular and cerebrovascular diseases, coronary heart disease, angina pectoris, cerebral embolism, cerebral vasospasm, etc. This trial is a randomized, double-blind, placebo-controlled multicenter clinical trial. The aim was to observe the effectiveness and safety of Shuxuening injection in the treatment of acute ischemic stroke for 10 days, and to continue follow-up to 90 days after the onset. ;

Related Conditions & MeSH terms

• Acute Ischemic Stroke
• Cerebral Infarction
• Ischemia
• Stroke

• NCT number: NCT04950790
• Study type: Interventional
• Source: Peking University Third Hospital
• Contact: Xiaogang Li
• Phone: 13501095002
• Email: xgangli2002@163.com
• Status: Recruiting
• Phase: Phase 4
• Start date: April 1, 2018
• Completion date: December 1, 2021