Pediatric Mycoplasma pneumoniae infection bronchitis
Conditions
Interventions
Experimental Group:Azithromycin powder for suspension + KZ5 Chinese herbal formula granules
Control Group:Azithromycin dry powder for suspension + KZ5 Chinese herbal formula granules placebo
Sponsors
China Academy of Traditional Chinese Medicine, Xiyuan Hospital
Eligibility
Sex/Gender
All
Age
3 Years to 14 Years
Inclusion criteria
Inclusion criteria: 1. Meets the diagnostic criteria for Mycoplasma pneumoniae infection bronchitis in Western medicine; 2. Meets the diagnostic criteria for cough with Wind-Heat invading the Lung pattern in Traditional Chinese Medicine; 3. No gender restrictions, age 3 to 14 years old (inclusive of 3 and 14 years); 4. Disease duration =72 hours; 5. Severity of cough (daytime cough + nighttime cough) score =3 points; 6. The subject's guardian understands and signs the informed consent form; if the subject is already 8 years old or older, they must also sign the informed consent form; if the subject is under 8 years old but can express agreement, their consent must be clearly documented.
Exclusion criteria
Exclusion criteria: 1. Participants with acute infectious diseases such as measles, pertussis, influenza, suppurative tonsillitis, acute infectious laryngitis, bronchiolitis, wheezing bronchitis, lung abscess, and tuberculosis; 2. Participants with a history of febrile seizures; 3. Participants with a total white blood cell count >13.0×109/L, neutrophil count =1.2 ULN, or C-reactive protein >30.0 mg/L, and those who need to be excluded based on the investigator's judgment; 4. Participants who have used cough-relieving and expectorant drugs within 12 hours prior to enrollment or drugs that may interfere with the evaluation of trial efficacy within 48 hours; 5. Participants with severe underlying diseases of the heart, liver, kidneys, digestive system, or hematopoietic system, including those with aspartate aminotransferase (AST), alanine aminotransferase (ALT), and blood urea nitrogen (BUN) exceeding 1.5 times the upper limit of normal values, or creatinine (Cr) exceeding the upper limit of normal values; 6. Participants with immunodeficiency; 7. Participants with severe diseases such as malignant tumors, liver and kidney diseases, hematological diseases, or mental disorders; 8. Participants with a history of allergy to the investigational drug or its components; 9. Participants who have participated in other clinical studies within 30 days prior to the screening period; 10. Other situations deemed unsuitable for participation in the study by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in cough severity score after 7 days of treatment compared to baseline.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Cough symptom disappearance rate;cough suppressant time to effectiveness;Time when cough basically disappears;The time when coughing up phlegm has basically disappeared.;Clinical cure rate;Severe conversion rate;Fever Evaluation;Efficacy rate of Traditional Chinese Medicine syndromes;Laboratory examination indicators: Improvement of C-reactive protein.;The usage of antipyretics and antibiotics; | — |
Countries
China
Contacts
Public ContactLi Qiuyan, Huang Jing
China Academy of Traditional Chinese Medicine, Xiyuan Hospital
Outcome results
None listed