An Add-on Study to Evaluate the Efficacy and Safety of Xiyanping Injection in Pediatric Bronchitis Patients.
NCT ID: NCT02937857
Last Updated: 2017-12-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE4
240 participants
INTERVENTIONAL
2016-08-31
2020-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Standard treatment only
Standard treatment only such as antiasthmatic, expectorant and antipyretic
Standard treatment only
standard treatment， such as antiasthmatic,expectorant,antipyretic
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+Xiyanping injection:standard treatment， such as antiasthmatic, expectorant and antipyretic plus Xiyanping injection,0.2-0.4mL/kg/day,qd for 5 days.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
1 Year
3 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Jiangxi Qingfeng Pharmaceutical Co. Ltd.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Liu Han Min, professor
Role: PRINCIPAL_INVESTIGATOR
Sichuan University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Guangzhou women and children health care center
Guangzhou, Guangdong, China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Deng Li, professor
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
JXQF-XYP-1606
Identifier Type: -
Identifier Source: org_study_id