Acute respiratory infection with thick sputum
Conditions
Interventions
Experimental group:Ambroxol hydrochloride spray (Luorunchang)
Control group:Ambroxol hydrochloride oral solution (Belle)
Sponsors
Ji'nan Children's Hospital
Eligibility
Sex/Gender
All
Age
2 Years to 6 Years
Inclusion criteria
Inclusion criteria: 1. Aged 2-6 years, gender is not limited; 2. Patients with acute respiratory tract infection (acute bronchitis, acute upper respiratory tract infection, acute pneumonia, etc.) with thick sputum (day or night cough symptom score >= 2 points); 3. Conditional daily observation and recorder.
Exclusion criteria
Exclusion criteria: 1. Have used expectorants within 24 hours before enrollment (expectants include ambroxol, bromhexine, acetylcysteine, carbocisteine, fudosteine, erdosteine, potassium iodide, ammonium chloride, myrtle, eucalyptus limonene and ipratropium bromide); 2. Children with bronchial asthma and interstitial lung disease in the past; 3. Children with other chronic respiratory diseases in the past, such as primary ciliary dyskinesia, bronchiectasis; 4. Patients with previous systemic diseases such as heart, brain, kidney, blood, immunity, endocrine, etc., such as congenital heart disease, epilepsy, hemophilia and autoimmune diseases, or children with congenital respiratory diseases and malnutrition; 5. Children with peptic ulcer in the past; 6. Children with liver function test ALT or AST > 1.5 times the upper limit of normal value, or TBil > upper limit of normal value, or renal function test Scr > upper limit of normal value; 7. Those who are known to be allergic to the ingredients contained in the drugs used in this study; 8. Those who are participating in other clinical trials or have participated in other clinical trials within the past 3 months; 9. Suspect or do have a history of drug abuse, or according to the investigator's judgment, other diseases or conditions that reduce the possibility of enrollment or complicate enrollment; 10. The child has poor compliance and cannot complete this clinical researcher; 11. The investigator believes that it is not suitable to participate in this clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes of cough symptom scores before and after treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Degree of improvement in quality of life;Compliance assessment;Cost-effectiveness analysis;Incidence of adverse events; | — |
Countries
China
Contacts
Public ContactZhang Xiaoting
Outcome results
None listed