Clinical efficacy and safety trial of adding Tanreqing Injection for pediatric lobar pneumonia (sputum heat closed lung syndrome)

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ITMCTR

Registry ID

ITMCTR2023000060

Enrollment

Unknown

Registered

2023-11-30

Start date

2023-12-01

Completion date

Unknown

Last updated

2023-12-18

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 presenting with lobar pneumonia

Interventions

None listed

Eligibility

Sex/Gender

All

Age

2 Years to 14 Years

Inclusion criteria

Inclusion criteria: (1) Inpatients who meet the Western medicine diagnostic criteria of Mycoplasma pneumoniae pneumonia in children presenting with lobar pneumonia; (2) Meet the diagnostic criteria of TCM syndrome differentiation, phlegm, heat and closed lung syndrome; (3) Between 2 and 14 years old, without gender limitation; (4) The legal guardian understands and signs the informed consent form (children aged 10 years old and above who can understand and sign their own name should also sign it).

Exclusion criteria

Exclusion criteria: (1) Patients with other respiratory diseases except mycoplasma pneumoniae pneumonia manifested by lobar pneumonia; (2) Patients with severe primary diseases and mental diseases such as heart (congenital heart disease, myocarditis, etc.), liver (upper limit of AST and ALT), kidney (BUN, upper limit of Scr> normal value) and hematopoietic system (anemia above moderate degree); (3) Serious abnormal blood oxygen saturation (<85%); (4) People who are allergic to the recommended use of drugs; (5) Children with acute infectious diseases such as measles and pertussis; (6) Children with severe malnutrition and immunodeficiency; (7) Patients who have participated in or are participating in the clinical trials of other drugs within the past one month; (8) The investigator is not unsuitable for inclusion in the clinical trial.

Design outcomes

Primary

Measure	Time frame
Time to the disappearance of all symptoms;	—

Secondary

Measure	Time frame
Imaging changes (normalization, improvement, no change, aggravation);The antipyretic time;length of stay;Change in the total integral of TCM syndrome;All symptoms resolved for time;The disappearance of individual symptom;Subtraction rate for all symptom improvements;The subtraction rate of the improvement of TCM syndrome;recurernce rate;Individual TCM symptoms continue to disappear;All TCM symptoms continue to disappear;	—

Measure

Time frame

Imaging changes (normalization, improvement, no change, aggravation);The antipyretic time;length of stay;Change in the total integral of TCM syndrome;All symptoms resolved for time;The disappearance of individual symptom;Subtraction rate for all symptom improvements;The subtraction rate of the improvement of TCM syndrome;recurernce rate;Individual TCM symptoms continue to disappear;All TCM symptoms continue to disappear;

—

Countries

China

Contacts

Public ContactQin jie

YANCHENG NO.1 PEOPLE'S HOSPITAL

qinjieyc@163.com18962081299

Outcome results