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Evaluation for the safety and effect of shortening the course and improving the disease of different doses of Jinzhen oral liquid combined with azithromycin(Xishumei) in the treatment of mycoplasma pneumoniae pneumonia in children:a randomized,double-blind,three-arm parallel control,multicentric clinical study

Evaluation for the safety and effect of shortening the course and improving the disease of different doses of Jinzhen oral liquid combined with azithromycin(Xishumei) in the treatment of mycoplasma pneumoniae pneumonia in children:a randomized,double-blind,three-arm parallel control,multicentric clinical study

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800019007
Enrollment
Unknown
Registered
2018-10-21
Start date
2018-10-22
Completion date
Unknown
Last updated
2018-10-22

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

double dose group:Jinzhen oral liquid (double dose of instruction) + Basic therapy (azithromycin)
original group:Jinzhen oral liquid (original dose of instruction) + Basic therapy (azithromycin)
placebo group:Jinzhen oral liquid placebo + Basic therapy (azithromycin)

Sponsors

First Teching Hospital of Tijianjin University of TCM
Lead Sponsor

Eligibility

Sex/Gender
All
Age
2 Years to 13 Years

Inclusion criteria

Inclusion criteria: 1. Children meeting the diagnostic criteria of MPP and TCM syndrome differentiation; 2. Aged 2 to 13 years old; 3. Etiological diagnossis:detected mixed antibody of IgM and IgG in serum by PA,the single MP test antibody titer was greater than 1:160, or the single ELISA test of MP-IgM was positive; 4. Written ICF obtained from a legally acceptable representative or the child(=8 years old).

Exclusion criteria

Exclusion criteria: 1. Children meeting the diagnosis of severe CAP; 2. Children meeting the diagnosis of refractory MPP; 3. Children have some disease need to identify to MPP,such as tuberculosis, bacterial or viral pneumonia, hospital-acquired pneumonia, and other pathogenic microbial pneumonia; 4. Those who have underlying disease,such as primary immunodeficiency disease, acquired immunodeficiency syndrome, congenital respiratory tract malformation, pulmonary dysplasia, aspiration pneumonia, and pulmonary malignancies; 5. Children with severe malnutrition, rickets, and serious primary diseases of heart, brain, liver, kidney and hematopoiesis; 6. Children who was infection by mycoplasma pneumoniaewas in the last 3 months; 7. Allergic constitution ( for two or more substances allergies ) or the preparation of known composition allergies; 8. Those who are not included based on the investigators judgment.

Design outcomes

Primary

MeasureTime frame
Time of clinical recovery;

Secondary

MeasureTime frame
antipyretic time;Relieving time of cough and expectoration;Ratio of transfer to severe CAP or refractory MPP;Effective rate of Chest x-rays;Effects of TCM symptoms;

Countries

Chian

Contacts

Public ContactLi Xinming

The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine

tjtcmlxm@163.com+86 13902095399

Outcome results

None listed

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