Clinical efficacy and safety trial of adding Tanreqing Injection for pediatric lobar pneumonia (sputum heat closed lung syndrome)
- Conditions
- Mycoplasma pneumoniae pneumonia in children presenting with lobar pneumonia
- Registration Number
- ITMCTR2023000060
- Lead Sponsor
- YANCHENG NO.1 PEOPLE'S HOSPITA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- Not specified
(1) Inpatients who meet the Western medicine diagnostic criteria of Mycoplasma pneumoniae pneumonia in children presenting with lobar pneumonia;
(2) Meet the diagnostic criteria of TCM syndrome differentiation, phlegm, heat and closed lung syndrome;
(3) Between 2 and 14 years old, without gender limitation;
(4) The legal guardian understands and signs the informed consent form (children aged 10 years old and above who can understand and sign their own name should also sign it).
(1) Patients with other respiratory diseases except mycoplasma pneumoniae pneumonia manifested by lobar pneumonia;
(2) Patients with severe primary diseases and mental diseases such as heart (congenital heart disease, myocarditis, etc.), liver (upper limit of AST and ALT), kidney (BUN, upper limit of Scr> normal value) and hematopoietic system (anemia above moderate degree);
(3) Serious abnormal blood oxygen saturation (<85%);
(4) People who are allergic to the recommended use of drugs;
(5) Children with acute infectious diseases such as measles and pertussis;
(6) Children with severe malnutrition and immunodeficiency;
(7) Patients who have participated in or are participating in the clinical trials of other drugs within the past one month;
(8) The investigator is not unsuitable for inclusion in the clinical trial.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Time to the disappearance of all symptoms;
- Secondary Outcome Measures
Name Time Method Imaging changes (normalization, improvement, no change, aggravation);The antipyretic time;length of stay;Change in the total integral of TCM syndrome;All symptoms resolved for time;The disappearance of individual symptom;Subtraction rate for all symptom improvements;The subtraction rate of the improvement of TCM syndrome;recurernce rate;Individual TCM symptoms continue to disappear;All TCM symptoms continue to disappear;