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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2016 by Jiangxi Qingfeng Pharmaceutical Co. Ltd.
Sponsor:
Information provided by (Responsible Party):
Jiangxi Qingfeng Pharmaceutical Co. Ltd.
ClinicalTrials.gov Identifier:
NCT02937857
First received: September 20, 2016
Last updated: October 18, 2016
Last verified: September 2016
  Purpose
This is a multicenter, randomized, open Label,add-on study.

Condition Intervention Phase
Bronchitis
Drug: Standard treatment only
Drug: Standard treatment+Xiyanping injection
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Open Label, Add-on Study to Assess Efficacy and Safety of Xiyanping Injection in Subjects With Pediatric Bronchitis

Resource links provided by NLM:


Further study details as provided by Jiangxi Qingfeng Pharmaceutical Co. Ltd.:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 240
Study Start Date: August 2016
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

  Eligibility

Ages Eligible for Study:   1 Year to 3 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02937857

Contacts
Contact: Chen Xiao 010-84682600 chenxiao@sh-qingfeng.net

Locations
China, Guangdong
Guangzhou women and children health care center Recruiting
Guangzhou, Guangdong, China, 510623
Contact: Deng Li, professor    020-38076348    drdengli@126.com   
Sponsors and Collaborators
Jiangxi Qingfeng Pharmaceutical Co. Ltd.
Investigators
Principal Investigator: Liu Han Min, professor Sichuan University
  More Information

Responsible Party: Jiangxi Qingfeng Pharmaceutical Co. Ltd.
ClinicalTrials.gov Identifier: NCT02937857     History of Changes
Other Study ID Numbers: JXQF-XYP-1606
Study First Received: September 20, 2016
Last Updated: October 18, 2016
Individual Participant Data  
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Bronchitis
Acute Disease
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections
Disease Attributes
Pathologic Processes
Antipyretics
Expectorants
Anti-Asthmatic Agents
Physiological Effects of Drugs
Respiratory System Agents

ClinicalTrials.gov processed this record on March 24, 2017