Acute bronchitis
Conditions
Interventions
Control group:Very low dose Qingke Pingchuan granules, 6-9 years old group: 1 bag (6g)/times, 10-14 years old group: 1 bag (8g)/times, taken with boiling water, 3 times a day.
Experimental group:Qingke Pingchuan granules 6-9 years old group: 1 bag (6g)/times 10-14 years old group: 1 bag (8g)/times taken with boiling water 3 times a day.
Sponsors
The First Affiliated Hospital of Henan University of Chinese Medicine
Eligibility
Sex/Gender
All
Age
6 Years to 14 Years
Inclusion criteria
Inclusion criteria: (1) Meet the Western diagnostic criteria for acute bronchitis in children; (2) TCM syndrome differentiation is phlegm-heat stagnation lung syndrome; (3) 6 years old = age =14 years old gender is not limited; (4) Duration =48 hours; Course of disease: From the onset of symptoms of acute bronchitis (cough phlegm lung rales chest pain with cough dyspnea) to the time of random admission. (5) Bronchitis severity score (BSS) >=5 points; (6) Cough symptom score >=2 points during the day or at night; (7) Legal guardian or children >=8 years old informed consent and signed informed consent.
Exclusion criteria
Exclusion criteria: (1) severe bronchitis and pneumonia are difficult to distinguish in early stage; (2) suffering from acute infectious diseases such as measles whooping cough and influenza; (3) Children with acute upper respiratory tract infection suppurative tonsillitis acute infectious laryngitis bronchiolitis bronchoppneumonia pulmonary abscess tuberculosis COVID-19 infection and other respiratory tract diseases; (4) Children with bronchial asthma multi-factor induced asthma and positive asthma prediction index; (5) Children with acute onset of chronic bronchitis; (6) The total number of white blood cells was > 12×10^9/L the percentage of neutrophil was > 70% and the investigators determined that the bacteria were infected; (7) Children with malnutrition and immune deficiency; (8) Children with body temperature (axillary temperature) exceeding 38.0? at the time of screening and 24h before screening or with febrile convulsion within the previous year; (9) Liver function test values (ALT AST) > 1.5 times the upper limit of no
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of subjects meeting disease efficacy criteria on day 5; | — |
Secondary
| Measure | Time frame |
|---|---|
| Emergency drug use and times of use during the test;The rate of cough disappearance on the 3rd, 5th and 7th day of medication;Clinical recovery time of the disease after medication;Evaluation of the curative effect of TCM syndromes on the 5th and 7th day of medication (recovery rate, apparent rate, total effective rate);The disappearance rate of TCM single symptoms (cough, expectoration, phlegm in throat, shortness of breath/wheezing, fever, sore throat, thirst, red face, short red urine, dry stool) on the 5th and 7th day of medication;Onset time of cough relief after medication administration;Disappearance rates of individual major symptoms (cough expectoration pulmonary rales chest pain during coughing dyspnea) on Day 5 and Day 7 of medication;Time for cough to disappear after medication;Incidence of pneumonia in children during the trial.;Clinical recovery rate on the 5th and 7th day of medication;The amount and frequency of antibiotic use during the trial;Time of disappearance of the single major symptoms (cough, sputum, chest pain during cough, dyspnea) after medication;The disappearance rate of single major symptoms (cough, sputum, pulmonary rales, chest pain during cough, dyspnea) on the 5th and 7th day of medication; | — |
Countries
China
Contacts
Public ContactRen Xianqing
The First Affiliated Hospital of Henan University of Chinese Medicine
Outcome results
None listed