Acute bronchitis
Conditions
Interventions
Experimental group:Xiao'er Huangjin Zhike Granules: For oral administration, 2 sachets each time, twice a day
Ambroxol Hydrochloride Oral Solution (trade name: Mucosolvan): For oral administration, 2.5ml (0.6%) each time, three times a day.
Control group:Ambroxol Hydrochloride Oral Solution (trade name: Mucosolvan): For oral administration, 2.5ml (0.6%) each time, three times a day.
Sponsors
Shanghai Children's Hospital
Eligibility
Sex/Gender
All
Age
3 Years to 7 Years
Inclusion criteria
Inclusion criteria: 1. Aged 3 to 7 years (inclusive), with no restriction on gender; 2. Meeting the Western medicine diagnostic criteria for acute bronchitis; 3. Meeting the traditional Chinese medicine syndrome differentiation criteria for phlegm-heat obstructing the lung syndrome; 4. Course of disease = 3 points; 6. The legal guardian of the child subject agrees to participate in the clinical trial and signs the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Children with other respiratory diseases such as bronchial asthma, bronchiolitis, asthmatic bronchitis, and bronchopneumonia; 2. Children with acute infectious diseases such as measles, whooping cough, and influenza; 3. Children with a maximum body temperature > 38.5? within 24 hours before enrollment; 4. Children with malnutrition, immunodeficiency, or severe primary diseases of various systems; 5. Those with deficiency-cold of the spleen and stomach, poor appetite, and loose stools; 6. Children with phenylketonuria or diabetes; 7. Children with mental diseases such as mania, schizophrenia, or those who cannot cooperate with the observation and research for other reasons; 8. Those with allergic diathesis or allergies to the trial drugs or their components; 9. Patients who participated in other clinical trials within 3 months before enrollment; 10. Other situations deemed inappropriate for participation in this trial by the researcher.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of subjects with complete/basically complete resolution of cough at Visit 5: Complete/basically complete resolution of cough: cough symptom score (daytime + nighttime) = 1 point and maintained for 24 hours or more; | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of subjects with complete/basically complete resolution of cough each day during the medication period;Time to complete/basically complete resolution of cough;Overall effective rate of disease efficacy at Visit 5:;Time to onset of antitussive effect: Onset of antitussive effect: The cough symptom score (daytime + nighttime) decreases by 1 point and persists for 24 hours or more.;Proportion of subjects with the onset of antitussive effect each day during the medication period;Changes in each score in the daily symptom score table compared with the baseline during the medication period;Changes in inflammatory indicators (white blood cells, C-reactive protein, etc.) from baseline at Visit 5;Changes in the total score of TCM syndromes from baseline at Visit 5;Changes in scores of individual TCM symptoms/signs from baseline at Visit 5; | — |
Countries
China
Contacts
Public ContactDong Xiaoyan
Shanghai Children's Hospital
Outcome results
None listed