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

Bronchitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02937857
• Other study ID #: JXQF-XYP-1606
• Status: Recruiting
• Phase: Phase 4
• First received: September 20, 2016
• Last updated: December 4, 2017
• Start date: August 2016
• Est. completion date: August 2020

Study information

• Verified date: September 2016
• Source: Jiangxi Qingfeng Pharmaceutical Co. Ltd.
• Contact: Chen Xiao
• Phone: 010-84682600
• Email: chenxiao[@]sh-qingfeng.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: August 2020
• Est. primary completion date: April 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 3 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Disease
• Bronchitis

Intervention

Drug:
• Standard treatment only
standard treatment, such as antiasthmatic,expectorant,antipyretic
• 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.

Locations

Country	Name	City	State
China	Guangzhou women and children health care center	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Jiangxi Qingfeng Pharmaceutical Co. Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	time to total score of the clinical symptoms/signs decreased more than 70% from baseline		up to 30 days after the last Administration
Secondary	The total efficiency rate		Day 3 and Day 5
Secondary	Time to defervescence		up to 30 days after the last Administration
Secondary	Day(s) of Hospital Stay		up to 30 days after the last Administration
Secondary	Signs and Symptoms Score from baseline		up to 30 days after the last Administration
Secondary	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
Secondary	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
Secondary	Incidence of complication	record the incidence of new complication after treatment.	up to 30 days after the last Administration
Secondary	Sputum status	record the incidence of expectoration and the day of expectoration disappear	up to 30 days after the last Administration
Secondary	Expenditure of therapeutic drug		up to 30 days after the last Administration
Secondary	The total expenditure of treatment	Expenditure of treatment include the cost of durg, hospitalization,examination	up to 30 days after the last Administration
Secondary	incidence of adverse events		up to 30 days after the last Administration