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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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

Detailed Summary:

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


Sponsor: Jiangxi Qingfeng Pharmaceutical Co. Ltd.

Current Primary Outcome: time to total score of the clinical symptoms/signs decreased more than 70% from baseline [ Time Frame: up to 30 days after the last Administration ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

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


Original Secondary Outcome:

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


Information By: Jiangxi Qingfeng Pharmaceutical Co. Ltd.

Dates:
Date Received: September 20, 2016
Date Started: August 2016
Date Completion: December 2017
Last Updated: October 18, 2016
Last Verified: September 2016