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A randomized, double-blind, parallel-controlled, multicenter trial to evaluate the effectiveness and safety of Xiyanping injection combined with azithromycin and azithromycin in the treatment of mycoplasma pneumoniae pneumonia in children

A randomized, double-blind, parallel-controlled, multicenter trial to evaluate the effectiveness and safety of Xiyanping injection combined with azithromycin and azithromycin in the treatment of mycoplasma pneumoniae pneumonia in children

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2000003093
Enrollment
Unknown
Registered
2020-03-07
Start date
2020-03-04
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

Interventions

Sponsors

The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
5 Years to 14 Years

Inclusion criteria

Inclusion criteria: 1. Aged 5 to 14 years at the time of screening; 2. Children who meet the Western medicine clinical diagnosis standard of Mycoplasma pneumoniae (Chinese hospitals also need to meet the Chinese medicine syndrome standard of "wind-heat-closed-lung / phlegm-heat-closed-lung / toxic-heat-closed-lung syndrome"), and the mycoplasma pneumoniae IgM antibody titer >=1:80, or Mycoplasma pneumoniae DNA or RNA (PCR) test positive, or rapid identification of Mycoplasma pneumoniae antibodies positive; 3. Heat course =8 years of age need to voluntarily sign the informed consent form); 6. According to the researcher's judgment, the subject / legal guardian is believed to be reliable and able to comply with this plan, visit plan and medication arrangement.

Exclusion criteria

Exclusion criteria: 1. Have diseases that need to be distinguished from Mycoplasma pneumoniae pneumonia (MPP), such as tuberculosis, bacterial or viral pneumonia, hospital-acquired pneumonia, and other pathogenic microorganisms pneumonia; 2. Patients with basic diseases such as primary immunodeficiency disease, acquired immunodeficiency syndrome, congenital respiratory malformation, abnormal lung development, aspiration pneumonia, lung malignancies, etc .; 3. Those who have been diagnosed with Mycoplasma pneumoniae in the past 3 months.

Design outcomes

Primary

MeasureTime frame
Incidence of severe CAP or refractory MPP;Clinical recovery time;Cough relief time;fever;

Countries

China

Contacts

Public ContactXinmin Li

The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine

tjtcmlxm@163.com+86 022-27432299

Outcome results

None listed

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