Skip to content

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

Qushi Tongluo decoction combined with azithromycin in the treatment of Mycoplasma pneumoniae pneumonia in children: a randomized, double-blind, single simulation, placebo-controlled, multicenter clinical trial

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2100004309
Enrollment
Unknown
Registered
2021-01-23
Start date
2021-03-01
Completion date
Unknown
Last updated
2023-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mycoplasma pneumoniae pneumonia in children

Interventions

Sponsors

Affiliated Hospital of Shandong University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
routine blood test;electrocardiogram;Stool routine;Chest radiograph;urinalysis;Myocardial enzymes;Vital signs;Kidney function;liver function;

Countries

China

Contacts

Public ContactZhang Baoqing

Affiliated Hospital of Shandong University of traditional Chinese Medicine

baoqing09009@126.com+86 13793188117

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026