Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:48 PM
Ignite Modification Date:
2025-12-24 @ 6:48 PM
NCT ID:
NCT02937857
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Year
Maximum Age:
3 Years
Study:
NCT02937857
Study Brief:
Protocol Section:
NCT02937857