Clinical trial of Xuhanting granule in the treatment of children's recurrent respiratory tract infections

Not Applicable

Recruiting

• Conditions: recurrent respiratory tract infection

• Registration Number: ITMCTR2100004538
• Lead Sponsor: Guangdong Women and Children Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2023-02-20

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

(1) Age 6 months to 6 years old (including boundary value), gender unlimited;
(2) RRTIs was diagnosed according to the diagnostic criteria;
(3) At the time of screening, the disease was in non acute infection stage or recovered from acute infection for more than 1 week;
(4) The legal guardian agreed to participate in the test and signed the informed consent.

Exclusion Criteria

(1) Primary immune deficiency, acquired immune deficiency syndrome (AIDS), congenital respiratory malformation, congenital heart disease, congenital ciliated immobility syndrome, gastroesophageal reflux disease (GERD) and other primary respiratory infections.
(2) Respiratory tract infection caused by pneumonia, pulmonary abscess, tuberculosis, bronchiectasis, asthma, bronchial foreign body, hyperthyroidism, rheumatic fever and other diseases.
(3) In the three months before screening, immunomodulators or other drugs for RRTIs were used according to the doctor's order.
(4) Diabetes, rickets, calcium / phosphorus metabolism, or severe malnutrition.
(5) Serious primary diseases such as heart, liver, kidney and hematopoiesis, or abnormal examination of liver and kidney function (alt, AST >= 1.5 times of the upper limit of normal value, SCR > the upper limit of normal value).
(6) Suspected or confirmed hypersensitivity to test drug components.
(7) Participate in clinical trials of other drugs within one month before screening.
(8) Poor compliance with the trial protocol, possible dropout / loss of follow-up (at the discretion of the investigator).
(9) According to the judgment of the researchers, there are other conditions that are not suitable for the experiment.

Study & Design

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