Asthmatic Bronchitis in Children
Conditions
Interventions
Experimental Group:Z Oral Solution + in combination with (Ipratropium Bromide) Nebulized Inhalation
Control Group:Z Oral Solution Placebo Plus + Budesonide in combination with Ipratropium Bromide via nebulized inhalation
Sponsors
Henan University of Traditional Chinese Medicine First Affiliated Hospital
Eligibility
Sex/Gender
All
Age
2 Years to 6 Years
Inclusion criteria
Inclusion criteria: (1) Meets the diagnostic criteria for asthmatic bronchitis in Western medicine; (2) Meets the diagnostic criteria of Traditional Chinese Medicine (TCM), with the syndrome type being either wind-cold attacking the lung pattern or phlegm-dampness obstructing the lung pattern; (3) Age between 2-6 years old; (4) Duration of illness (wheezing and cough symptoms) =48 hours; (5) Body temperature within 24 hours prior to consultation =38.5?, and a severity score for pediatric bronchitis (BSS-ped) =5 points; (6) No use of other Western or Chinese medicine for asthma relief within the past week; (7) Parents have signed the informed consent form and have good compliance.
Exclusion criteria
Exclusion criteria: (1) Laboratory tests (blood collection on the day or within 24 hours) meet any of the following criteria, confirmed upon re-examination and deemed clinically significant by the investigator: a) ALT or AST > 1.5 × ULN, TBil > 1.5 × ULN; b) Scr > 1.2 × agespecific ULN or eGFR 38.5°C, or febrile seizures; (7) Coexisting severe heart, liver, lung, or hematological diseases, or other severe diseases affecting survival; (8) Coexisting severe immunodeficiency, malnutrition, or mental disorders in children; (9) Unable to cooperate with clinical examinations; (10) Known allergy to components of the investigational drug; (11) Participation in other clinical studies within 1 month prior to screening or currently participating; (12) Deemed by the investigator to be unsuitable for participation in this clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Major Symptoms and Signs Scoring; | — |
Secondary
| Measure | Time frame |
|---|---|
| Total Symptom Score (Primary Symptom Score + Secondary Symptom Score);Time of disappearance of clinical symptoms and signs (time until resolution of cough, wheezing, and stridor);Pulmonary function: For children under 5 years old, measure the peak expiratory flow volume ratio (VPEF/VE), peak expiratory time ratio (TPTEF/TE), tidal volume (VT), and respiratory rate (RR) during tidal breathing. For children 5 years old and above, measure the forced expiratory volume in the first second (FEV1), the percentage of the predicted value of FEV1 (FEV1%), and the ratio of FEV1 to the forced vital capacity (FEV1/FVC).;Recurrence rate; | — |
Countries
China
Contacts
Public ContactZhang Xia
Henan University of Traditional Chinese Medicine First Affiliated Hospital
Outcome results
None listed