Phase II Clinical Trial of Qingke Pingchuan Granules in Treating Acute Bronchitis in Childre
- Conditions
- Acute bronchitis in children
- Registration Number
- ITMCTR2100004581
- Lead Sponsor
- Shanghai Traditional Chinese Medicine Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
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.
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.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Clinical recovery time of disease ;
- Secondary Outcome Measures
Name Time Method Cough disappearance time, once every 24h (1d) after treatment ;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 ;Bronchitis severity score, baseline and treatment endpoint records ;Efficacy of TCM syndromes, treatment endpoint evaluation;Complication rate, antibiotic usage rate, treatment endpoint evaluation ;