Recurrent Respiratory Tract Infections (Syndrome of Superficial Asthenia and Insecure Exterior)
Conditions
Interventions
Control group:Simulator of Yu Ping Feng Granules
Treatment group:Yupingfeng Granules
Sponsors
Beijing Childrens Hostipal Capital Medical University
Eligibility
Sex/Gender
All
Age
2 Years to 11 Years
Inclusion criteria
Inclusion criteria: (1) Meet the diagnostic criteria for RRTIs in the 2024 Chinese Medical Diagnosis and Treatment Guidelines for Recurrent Respiratory Tract Infections in Children; (2) Conform to the syndrome differentiation criteria for the syndrome of exterior deficiency failing to consolidate in traditional Chinese medicine; (3) Age: 2 years old = age < 12 years old; (4) Non-acute infection period or =1 week after the acute infection has healed; (5) Provide full informed consent: For trial children under 8 years old parents or guardians shall sign the informed consent form; for trial children aged =8 years old both the children and their parents or guardians shall sign the informed consent form.
Exclusion criteria
Exclusion criteria: (1) Primary ciliary dyskinesia; history of combined chronic respiratory diseases or respiratory allergic diseases including asthma allergic rhinitis bronchiolitis obliterans chronic bronchitis chronic otitis media chronic rhinosinusitis etc.; those who have experienced severe pneumonia within 1 year prior to screening; those with airway malformations or developmental abnormalities; (2) Known or suspected primary immunodeficiency acquired immunodeficiency syndrome; (3) Those with severe systemic diseases involving the endocrine or hematopoietic systems tumors neuropsychiatric diseases or intellectual developmental disorders; (4) Abnormal liver and kidney function [such as aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 1.5 times the upper limit of the reference value serum creatinine (SCr) exceeding the upper limit of the reference value]; (5)Those who have used immunomodulators (immunoglobulin bacterial lysates pidotimod thymosin etc.) oral or injectable corticosteroids or taken traditional Chinese medicine with the main functions of tonifying qi consolidating the exterior and stopping sweating within the past 6 months; (6) Those allergic to the ingredients of Yupingfeng Granules or its excipients; (7) Those who have participated in other clinical studies that may affect the results of this study within the past 3 months; (8) Those whom the investigator deems unsuitable for inclusion in this trial.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Duration of respiratory tract infections during the study period (upper respiratory tract infections, bronchial infections, pulmonary infections);Exposure days to anti-infective drugs during the study period;Changes in immunological indicators after 8 weeks of treatment and 12 months after discontinuation of medication: serum immunoglobulins (IgA, IgM, IgG), T lymphocyte subsets (CD3+, CD4+, CD8+, CD4+/CD8+), and B lymphocyte count compared to baseline (immunological examination 12 months after discontinuation of medication is not mandatory);TCM syndrome efficacy rate after 4 and 8 weeks of treatment (proportion of patients with a reduction of =50% in syndrome score compared to baseline);Disappearance rate of single symptoms after 4 and 8 weeks of treatment;Changes in the number of upper and lower respiratory tract infections at the end of the 12-month follow-up period compared to the baseline period;Proportion of respiratory tract infections during the study period (upper respiratory tract infections, bronchial infections, pulmonary infections);Hospitalization time due to respiratory tract infection episodes during the study period; | — |
Primary
| Measure | Time frame |
|---|---|
| Clinical cure rate of patients at the end of the 12-month follow-up period (proportion of patients with respiratory tract infection frequency meeting the normal standard for the same age group); | — |
Countries
China
Contacts
Public ContactBaoping Xu
Beijing Childrens Hostipal Capital Medical University
Outcome results
None listed