NCT02937857

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

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 240 (estimated)
• Sponsor: Jiangxi Qingfeng Pharmaceutical Co. Ltd. · Industry
• Sex: All
• Age: 1 Year – 3 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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

Conditions

• Bronchitis

Interventions

Type	Name	Description
DRUG	Standard treatment only	standard treatment， such as antiasthmatic,expectorant,antipyretic
DRUG	Standard treatment+Xiyanping injection	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.

Timeline

• Start date: 2016-08-01
• Primary completion: 2020-04-01
• Completion: 2020-08-01
• First posted: 2016-10-19
• Last updated: 2017-12-06

Locations

1 site across 1 country: China