Efficacy and Safety of Intramuscular Injection of Xiyanping Injection in the Treatment of Acute Bronchitis in Children: a Multicenter, Randomized, Parallel Controlled Clinical Study
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 主要终点
- Total clinical effective rate
研究概览
简要总结
Any pathogen that causes an upper respiratory tract infection can cause bronchitis.The primary pathogen is virus. On the basis of virus infection, pathogenic bacteria may cause secondary infection or co-infection。Xiyanping injection is mainly used in the treatment of bronchitis by intravenous injection。
详细描述
To further verify the clinical value and safety of intramuscular injection of Xiyanping injection in the treatment of acute bronchitis in children, provide reference for subsequent validation studies, and provide more reasonable and standard application guidance and basis for clinical practice.A multicenter, randomized, parallel controlled study was conducted on the treatment of acute bronchitis by intramuscular injection of Xiyanping injection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 1-6 years (>1 years, ≤6years);
- •Children who meet the diagnosis criteria of acute bronchitis in children;
- •All symptoms, including cough, had been present for less than 72 hours at the time of inclusion screening;
- •The informed consent process complies with the regulations, and the legal guardian signs the informed consent.
排除标准
- •Have used Chinese medicine injection containing andrographolide and similar functions (clearing heat and detoxifying, relieving cough and stopping dysentery) or oral dosage within 72 hours.
- •Children with severe bronchitis or early pneumonia;
- •Children with acute infectious diseases such as measles, pertussis,influenza and hand-foot-and-mouth disease;
- •Children with diseases such as acute upper respiratory tract infection, suppurative tonsillitis, wheezing bronchitis, bronchial asthma, bronchiolitis pneumonia, tuberculosis, tumor;
- •neutrophil granulocyte>80%, or those who need antibiotic therapy;
- •Children with severe malnutrition and immunodeficiency;
- •Children with severe primary diseases such as heart, liver, kidney, digestion and hematopoietic system;
- •Allergic constitution and children allergic to the drug used in this study;
- •Children who are taking epinephrine, isoproterenol and other catecholamines;
- •Children who are taking MAO inhibitors or tricyclic antidepressants
- •Children who are taking non-selective β-blockers such as Propranolol;
- •Those who are not included based on the investigators judgment.
研究组 & 干预措施
Xiyanping injection combined with routine treatment
干预措施: Xiyanping injection (Drug)
结局指标
主要结局
Total clinical effective rate
时间窗: up to day 7
The children were evaluated according to the improvement of body temperature (axillary temperature), cough, expectoration, lung rales and other symptoms and signs and the improvement time
次要结局
- Fever relief(up to day 7)
- Cough easing(up to day 7)
- Lung rales relieved(up to day 7)