Recurrent Respiratory Tract Infections
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: (1) complied with the pediatric Western diagnostic criteria of RRTI; (2) consistent with lung spleen qi deficiency syndrome of TCM diagnostic criteria; (3) children suffering in an acute infective stage; (4) children at the age of 2 years old to 14 years old; (5) signed informed consent form.
Exclusion criteria
Exclusion criteria: (1) in acute stage of respiratory tract infection; (2) a simple upper respiratory tract infection; (3) severe malnutrition, rickets, measles or other infectious disease during acute stage; (4) children suffering from congenital heart disease, congenital respiratory, digestive tract malformation; children suffering severe primary complicated diseases in heart, liver, kidney and blood system; (5) patients with iatrogenic immune hypofunction resulted from long-term use of corticosteroids, immunosuppressive agents, cytotoxic drugs, receiving radiotherapy or patients with prolonged antibiotic use; (6) children within the past 12 months using other immunomodulators such as thymosin or receiving polyvalent bacterial vaccine treatment; (7) allergic children (of more than two types of sensitivities) or children known as allergic to the ingredient of this preparation; (8) except children with primary immunodeficiency diseases; (9) lost of follow up due to the doctor's judgment; (10) subjects who participated in other clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the times of acute attacks of RRT;Serum immunoglobulin (IgA, IgM, IgG); T lymphocyte subsets(CD3, CD4, CD8), SIgA; | — |
Secondary
| Measure | Time frame |
|---|---|
| RRTI in acute episode duration,Disease, severity, TCM syndrome scoring, individual symptom efficacy; | — |
Countries
China