Acute bronchitis in children
Conditions
Interventions
Sponsors
Shanghai Traditional Chinese Medicine Hospital
Eligibility
Sex/Gender
All
Age
6 Years to 14 Years
Inclusion criteria
Inclusion criteria: 1. Meet the diagnostic criteria of western medicine for acute bronchitis in children; 2. TCM syndrome differentiation accords with phlegm-heat stagnation syndrome; 3. 6 years old <= age <= 14 years old, no gender limit; 4. Course of disease <= 48h; 5. Parents or guardians voluntarily agree and sign the informed consent form, and the children = 8 years old participate in the informed consent and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Severe bronchitis and pneumonia are difficult to distinguish in the early stage; 2. Suffer from acute infectious diseases such as measles, whooping cough and influenza; 3. Children with acute upper respiratory tract infection, bronchial asthma, bronchiolitis, bronchopneumonia and other respiratory diseases; 4. Children with acute attacks of chronic bronchitis; 5. The total number of white blood cells > 12 x 10^9/L, and the percentage of neutrophils > 70%; 6. Children with malnutrition and immunodeficiency; 7. Children whose body temperature exceeds 38.0 degrees C; 8. Liver function test values (ALT, AST) > upper limit of normal value, blood creatinine > upper limit of normal value; 9. Those who are allergic to the test drug or its components; 10. Children who have used antibiotics, cough-reducing and phlegm-resolving medicines and other Chinese and Western medicines that have an impact on cough within 24 hours before treatment; 11. Combined with serious primary diseases such as severe heart, liver, kidney, digestive and hematopoietic system; 12. According to the judgment of the investigator, there are other diseases or conditions that reduce the possibility of enrollment or complicate enrollment, such as unstable living environment, inconvenient transportation, etc. that may easily cause loss to follow-up.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical recovery time of disease ; | — |
Secondary
| Measure | Time frame |
|---|---|
| Cough disappearance time, once every 24h (1d) after treatment ;Bronchitis severity score, baseline and treatment endpoint records ;TCM syndrome score, baseline, 3 days of treatment and treatment endpoint record ;Single symptoms (cough, expectoration, phlegm in the throat, shortness of breath/wheezing, fever, sore throat, thirst, red face, short urine, dry stool) disappearance rate, treatment endpoint evaluation ;Complication rate, antibiotic usage rate, treatment endpoint evaluation ;Efficacy of TCM syndromes, treatment endpoint evaluation; | — |
Countries
China
Contacts
Public ContactZhang Jie
Lei Yunshang Pharmaceutical Group Co., Ltd.
Outcome results
None listed