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

• Status: Unknown status
• Trial end date: 2020-08-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a multicenter, randomized, open Label,add-on study.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jiangxi Qingfeng Pharmaceutical Co. Ltd.
• Treatments: Anti-Asthmatic Agents; Antipyretics; Expectorants

Criteria

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