Research for the Clinical Effect and Immune Mechanism of Soothing the Lung and Anti-fever, Resolving Blood-stasis and Unblocking Collaterals in the Treatment of Mycoplasma Pneumoniae Pneumonia in Childre

Not Applicable

• Conditions: Mycoplasma Pneumoniae Pneumonia

• Registration Number: ITMCTR1900002294
• Lead Sponsor: First Teaching Hospital of Tianjin 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: Pending
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Mycoplasma pneumoniae pneumonia in children meets the western medical diagnostic criteria;
2. Thermal process>48h and<96h;
3. The cough is prominent and persistent,and graded=2;
4. Peripheral white blood cell (WBC)count was normal;
5. It conforms to the TCM syndrome standard of wind-heat closed the lung or poison-heat closed the lung;
6. The children are aged 5~14;
7. The informed consent process is in compliance with regulations,the legal representative of the children signed the informed consent files.

Exclusion Criteria

1. For children with severe pneumonia, segmental or lobar parenchymal infiltration shadow similar to that of bacterial pneumonia can be clearly diagnosed as bacterial pneumonia or viral pneumonia, and simple hilar lymphadenoma with large through the chest X-ray manifestations;
2. Those who have used macrolide antibiotics and hormones before enrollment;
3. Confirmed mycoplasma pneumoniae infection in the past 3 months;
4. Pulmonary complications, including pleural effusion or empyema, pneumothorax, pulmonary abscess, bronchopleural fistula, necrotizing pneumonia, and acute respiratory failure, have occurred;
5. Pulmonary infection caused by primary immunodeficiency disease, acquired immunodeficiency syndrome, congenital respiratory tract malformation, abnormal lung development, aspiration pneumonia, lung malignancy and other basic diseases;
6. Patients with severe malnutrition, rickets and severe primary diseases of heart, brain, liver, kidney and hematopoietic system;
7. Allergic constitution (allergic to more than 2 kinds of substances), or allergic to macrolide antibiotics and components of jinzhen oral liquid;
8. According to the researcher's judgment, those who are not suitable for enrollment.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
IL-10;Blood routine;blood IgM;IL-18;Blood IgA;Saliva sIgA;Complete antipyretic time;Intestinal sIgA;T cell subgroups;Complication rate;NF-kB;Electrocardiogram;Intestinal environment;Relieving time of cough and sputum cough;ROS;Urine routine;Liver function;Intestinal flora;TCM syndrome effect;Clinical recovery time;Kidney function;Alveolar lavage fluid proteomic analysis;Arg-1;Incidence of clinical adverse events/reactions;ADA;blood IgG;IL-17;NO;