An Add-on Study to Evaluate the Efficacy and Safety of Xiyanping Injection in Pediatric Bronchitis Patients.

Study Overview
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Brief Summary
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This is a multicenter, randomized, open Label,add-on study.

Detailed Description
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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

Official Title
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A Multicenter, Randomized, Open Label, Add-on Study to Assess Efficacy and Safety of Xiyanping Injection in Subjects With Pediatric Bronchitis

Conditions
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Bronchitis

Intervention / Treatment
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* Drug: Standard treatment only
* Drug: Standard treatment+Xiyanping injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 3 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard treatment only<br>Standard treatment only such as antiasthmatic, expectorant and antipyretic | Drug: Standard treatment only<br>* standard treatment， such as antiasthmatic,expectorant,antipyretic<br>* Other names: antiasthmatic,expectorant,antipyretic;|
| Experimental: Standard treatment+Xiyanping injection<br>Standard Treatment such as antiasthmatic, expectorant and antipyretic plus Xiyanping injection intravenous administration of 0.2-0.4mL/kg/day ,QD for 5 days. | Drug: Standard treatment+Xiyanping injection<br>* standard treatment+Xiyanping injection:standard treatment， such as antiasthmatic, expectorant and antipyretic plus Xiyanping injection,0.2-0.4mL/kg/day,qd for 5 days.<br>* Other names: antiasthmatic,expectorant,antipyretic + Xiyanping injection;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time to total score of the clinical symptoms/signs decreased more than 70% from baseline |  | up to 30 days after the last Administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The total efficiency rate |  | Day 3 and Day 5 | 
| Time to defervescence |  | up to 30 days after the last Administration | 
| Day(s) of Hospital Stay |  | up to 30 days after the last Administration | 
| Signs and Symptoms Score from baseline |  | up to 30 days after the last Administration | 
| Antibiotic consumption | check and record the usage of antibiotic,including durg Utilization Rate and the duration of usage | up to 30 days after the last Administration | 
| Usage of Inhaled corticosteroids | check and record the usage of Inhaled corticosteroids,including durg Utilization Rate and the duration of usage | up to 30 days after the last Administration | 
| Incidence of complication | record the incidence of new complication after treatment. | up to 30 days after the last Administration | 
| Sputum status | record the incidence of expectoration and the day of expectoration disappear | up to 30 days after the last Administration | 
| Expenditure of therapeutic drug |  | up to 30 days after the last Administration | 
| The total expenditure of treatment | Expenditure of treatment include the cost of durg, hospitalization,examination | up to 30 days after the last Administration | 
| incidence of adverse events |  | up to 30 days after the last Administration |