A Multicenter, Randomized, Open Label, Add-on Study to Assess Efficacy and Safety of Xiyanping Injection in Subjects With Pediatric Bronchitis
试验速览
- 阶段
- 4 期
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- time to total score of the clinical symptoms/signs decreased more than 70% from baseline
研究概览
简要总结
This is a multicenter, randomized, open Label,add-on study.
详细描述
This is an add-on study of efficacy and safety of intravenous injection of Xiyanping injection in subjects with pediatric bronchitis.
The purpose to determine the efficacy and safety of conventional treatment combined with or without Xiyanping injection in the treatment of pediatric bronchitis and to further evaluate the clinical value of Xiyanping injection in shortening the course of pediatric bronchitis
The study will enroll 240 Pediatric bronchitis volunteers, who will be randomized into 2 groups (1:1 ratio): volunteers from the first group will receive Routine treatment for pediatric bronchitis and Xiyanping injection; volunteers from the second group will receive Routine treatment for pediatric bronchitis. Xiyanping injection will be administration as intravenous injection of 0.2-0.4mL/kg/day once daily for 5 days concomitantly with Routine treatment for pediatric bronchitis
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 3 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of pediatric bronchitis with hospital treatment needed
- •Males and female subjects
- •Age between 1 and 3 years old
- •With fever, cough, gasp and expectoration symptoms
- •Have wheeze and/ or mid-fine rales on one's lungs
- •White blood cell count < 12 x 109 / L, categorized priority to leukocyte
- •C-reactive protein≤8mg/L or normal Super C- reactive protein
- •Had experienced ≤48 h course before enrollment
- •Previous Wheezing episodes≤2
- •Written informed consent
排除标准
- •Participants with severe clinical symptoms, meet any of the following：
- •SaO2≤0.92;（2）Shock or disturbance of consciousness;（3） Significantly speed up breathing , rapid pulse accompany with severe respiratory distress; or（4）Repeated occurrence of apnea or slow and irregular respiration;
- •Acute infectious disease such as measles, pertussis and influenza
- •Participants with bronchial asthma, bronchopneumonia and other respiratory diseases
- •Chronic lung diseases
- •Participants with complicated pyopneumothorax, airway obstruction, toxic encephalopathy, cardiac failure or respiratory failure
- •Participants with complicated severe underlying myocardial, liver, kidney, digestive and hematopoietic system diseases
- •Severe malnutrition and history of immune deficiency which may seriously affect the self-limiting process of the course
- •Participants with epilepsy and other disturbances of central nervous system
- •Participants with congenital diseases and psychosis
- •use of any other antiviral drugs within the 2 weeks before enrollment
- •use of systemic hormone within the 2 weeks before enrollment
- •Participants had a history of allergic constitution and drug allergy; Allergenic to XiYanPing injection and Andrographolide
- •Participants participated in other clinical research in the last three months
- •Any condition which would make the subject, in the opinion of the investigator or designee, not suitable for the study for any reason
研究组 & 干预措施
Standard treatment only
Standard treatment only such as antiasthmatic, expectorant and antipyretic
干预措施: Standard treatment only (Drug)
Standard treatment+Xiyanping injection
Standard Treatment such as antiasthmatic, expectorant and antipyretic plus Xiyanping injection intravenous administration of 0.2-0.4mL/kg/day ,QD for 5 days.
干预措施: Standard treatment+Xiyanping injection (Drug)
结局指标
主要结局
time to total score of the clinical symptoms/signs decreased more than 70% from baseline
时间窗: up to 30 days after the last Administration
次要结局
- Time to defervescence(up to 30 days after the last Administration)
- Day(s) of Hospital Stay(up to 30 days after the last Administration)
- The total efficiency rate(Day 3 and Day 5)
- Usage of Inhaled corticosteroids(up to 30 days after the last Administration)
- Incidence of complication(up to 30 days after the last Administration)
- The total expenditure of treatment(up to 30 days after the last Administration)
- Expenditure of therapeutic drug(up to 30 days after the last Administration)
- Signs and Symptoms Score from baseline(up to 30 days after the last Administration)
- Antibiotic consumption(up to 30 days after the last Administration)
- Sputum status(up to 30 days after the last Administration)
- incidence of adverse events(up to 30 days after the last Administration)