An Add-on Study to Evaluate the Efficacy and Safety of Xiyanping Injection in Pediatric Bronchitis Patients.
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|ClinicalTrials.gov Identifier: NCT02937857|
Recruitment Status : Recruiting
First Posted : October 19, 2016
Last Update Posted : December 6, 2017
|Condition or disease||Intervention/treatment||Phase|
|Bronchitis||Drug: Standard treatment only Drug: Standard treatment+Xiyanping injection||Phase 4|
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
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||240 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multicenter, Randomized, Open Label, Add-on Study to Assess Efficacy and Safety of Xiyanping Injection in Subjects With Pediatric Bronchitis|
|Study Start Date :||August 2016|
|Estimated Primary Completion Date :||April 2020|
|Estimated Study Completion Date :||August 2020|
Active Comparator: Standard treatment only
Standard treatment only such as antiasthmatic, expectorant and antipyretic
Drug: Standard treatment only
standard treatment， such as antiasthmatic,expectorant,antipyretic
Other Name: antiasthmatic,expectorant,antipyretic
Experimental: 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.
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.
Other Name: antiasthmatic,expectorant,antipyretic + Xiyanping injection
- 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 ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02937857
|Contact: Chen Xiaoemail@example.com|
|Guangzhou women and children health care center||Recruiting|
|Guangzhou, Guangdong, China, 510623|
|Contact: Deng Li, professor 020-38076348 firstname.lastname@example.org|
|Principal Investigator:||Liu Han Min, professor||Sichuan University|