Acute sinusitis in children
Conditions
Interventions
Application of Oulongma oral drops treatment group:NA
Sponsors
Henan Children's Hospital Zhengzhou Children's Hospital
Eligibility
Sex/Gender
All
Age
2 Years to 14 Years
Inclusion criteria
Inclusion criteria: 1. The patient (or the legal representative of the child) voluntarily provides an informed consent form or a child's informed consent form (if applicable) to participate in this study; 2. Age : = 2 years old to = 14 years old; 3. Acute rhinosinusitis that meets the diagnostic criteria of "Diagnosis and Treatment Recommendations for Children's Nasal Sinusitis (Kunming, 2012)"
Exclusion criteria
Exclusion criteria: 1. Congenital nasal developmental abnormalities; 2. History of previous nasal surgery; 3. Combined nasopharyngeal and nasal cavity tumors; 4. According to the researcher's judgment, patients who are not suitable to participate in this study due to any medical history, disease, condition, or treatment that might mislead the study endpoint and safety evaluation; 5. Patients who are contraindicated to Sinupret oral drops; 6. Subjects who are currently participating in any other intervention study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of patients whose main symptoms (completely) disappear on the 7th day (physician evaluated main symptom score MSS = 1, including nasal congestion, runny nose, cough, headache); | — |
Secondary
| Measure | Time frame |
|---|---|
| On the 7th day, the physician evaluated the mean change in the main symptom score (MSS) from baseline, including nasal congestion, runny nose, cough, facial pain/headache);On the 3rd, 7th, and 14th day, physicians evaluated the average and percentage changes in MSS compared to baseline;On the 3rd, 7th, and 14th day, the average and percentage changes in subjective symptom scores evaluated by patients compared to baseline;The proportion of patients with subjective symptom scores greater than 3 on the third, seventh, and fourteenth day of the baseline patient evaluation subjective symptom score = 3;On the 7th day, the Lund Kennedy score showed a change in mean and percentage from baseline;The proportion of patients with baseline Lund Kennedy score>3 and Lund Kennedy score = 3 on the 7th day;The proportion of patients with baseline Lund Kennedy score>1 and Lund Kennedy score = 1 on the 7th day;The proportion of patients with nasal secretion concentration (sticky/thin) before and after treatment;The proportion of patients with nasal secretion color (colored/transparent) before and after treatment;The average time to discontinue all ARS drug treatments for the first time;The proportion of patients who stopped all ARS drug treatments on the 7th day;Dosage and average duration of use of Sinupret? Oral Drops according to age;Average sleep time per night in the past 7 days; | — |
Countries
China
Contacts
Public ContactJie Zhang
Henan Children's Hospital Zhengzhou Children's Hospital
Outcome results
None listed