Qushi Tongluo decoction combined with azithromycin in the treatment of Mycoplasma pneumoniae pneumonia in childre

Phase 1

Recruiting

• Conditions: Mycoplasma pneumoniae pneumonia in children

• Registration Number: ITMCTR2100004309
• Lead Sponsor: Affiliated Hospital of Shandong University of Traditional Chinese Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Patients who meet the diagnostic criteria of Western medicine for Mycoplasma pneumoniae pneumonia in children;
2. Patients who meet the diagnostic criteria of damp heat obstructing lung syndrome;
3. Hospitalized children aged 1-12 years;
4. Patients with pneumonia within 48 hours of diagnosis;
5. For those subjects whose informed consent process meets the requirements, the legal representative should sign the informed consent form (>= 8 years old children should sign the informed consent form at the same time).

Exclusion Criteria

1. Patients with severe Mycoplasma pneumoniae pneumonia;
2. Patients with obvious pulmonary tumor and tuberculosis on chest X-ray;
3. Patients with measles, pertussis, influenza and other acute infectious diseases;
4. Patients with acute upper respiratory tract infection, asthmatic bronchitis, bronchial asthma, bronchial foreign body and other respiratory diseases;
5. Children with severe malnutrition and immunodeficiency;
6. Patients with severe primary diseases such as heart, liver, kidney, digestive and hematopoietic system;
7. Patients who have participated in or are participating in clinical trials of other drugs in the past three months;
8. Patients with allergic constitution (allergic to more than 2 kinds of substances), or allergic to azithromycin, Qushi Tongluo formula and its components;
9. Patients considered unsuitable by researchers.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
routine blood test;electrocardiogram;Stool routine;Chest radiograph;urinalysis;Myocardial enzymes;Vital signs;Kidney function;liver function;