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

December 4, 2017 updated by: Jiangxi Qingfeng Pharmaceutical Co. Ltd.

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

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

Study Overview

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

Study Type

Interventional

Enrollment (Anticipated)

240

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Guangdong
      • Guangzhou, Guangdong, China, 510623
        • Recruiting
        • Guangzhou women and children health care center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 3 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard treatment only
Standard treatment only such as antiasthmatic, expectorant and antipyretic
standard treatment, such as antiasthmatic,expectorant,antipyretic
Other Names:
  • 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.
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 Names:
  • antiasthmatic,expectorant,antipyretic + Xiyanping injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
up to 30 days after the last Administration

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The total efficiency rate
Time Frame: Day 3 and Day 5
Day 3 and Day 5
Time to defervescence
Time Frame: up to 30 days after the last Administration
up to 30 days after the last Administration
Day(s) of Hospital Stay
Time Frame: up to 30 days after the last Administration
up to 30 days after the last Administration
Signs and Symptoms Score from baseline
Time Frame: up to 30 days after the last Administration
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
up to 30 days after the last Administration
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
up to 30 days after the last Administration
Incidence of complication
Time Frame: up to 30 days after the last Administration
record the incidence of new complication after treatment.
up to 30 days after the last Administration
Sputum status
Time Frame: up to 30 days after the last Administration
record the incidence of expectoration and the day of expectoration disappear
up to 30 days after the last Administration
Expenditure of therapeutic drug
Time Frame: up to 30 days after the last Administration
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
up to 30 days after the last Administration
incidence of adverse events
Time Frame: up to 30 days after the last Administration
up to 30 days after the last Administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Liu Han Min, professor, Sichuan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2016

Primary Completion (Anticipated)

April 1, 2020

Study Completion (Anticipated)

August 1, 2020

Study Registration Dates

First Submitted

September 20, 2016

First Submitted That Met QC Criteria

October 17, 2016

First Posted (Estimate)

October 19, 2016

Study Record Updates

Last Update Posted (Actual)

December 6, 2017

Last Update Submitted That Met QC Criteria

December 4, 2017

Last Verified

September 1, 2016

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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