Status:
UNKNOWN
Effectiveness of Sodium Hyaluronate In Relieving Nasal Symptoms Of Children With Seasonal Allergic Rhinitis
Lead Sponsor:
Saglik Bilimleri Universitesi
Conditions:
Seasonal Allergic Rhinitis
Eligibility:
All Genders
6-12 years
Phase:
NA
Brief Summary
Nasal irrigation (NI) is recommended as an add-on therapy in patients with allergic rhinitis (AR). The primary purpose of this study was to evaluate the clinical effectiveness of adding hyaluronic aci...
Eligibility Criteria
Inclusion
- Pediatric patients between 6 to 12-year-old;
- Children must have a clinical history concordant to seasonal allergic rhinitis of the previous year;
- Children must have skin prick test (SPT) positivity to pollen (tree, grass, or weed) (Positive SPT is defined as; skin reaction with within 15 minutes after the test and 3 mm larger swelling compared to the negative control test; ALK, Hørsholm, Denmark)
- Children must have a total nasal symptom score (TNSS) of 4 or more on 4 of 7 days during the run-in period.
Exclusion
- Children who were treated with systemic/topical nasal corticosteroids, antihistamines or antibiotics, leukotriene receptor antagonists 4 weeks before the examination,
- those who had upper or lower respiratory tract infections;
- recipients of recent or ongoing allergen immunotherapy;
- active smokers;
- those with cystic fibrosis, immunodeficiency, septal deviation, nasal polyps, and ostio-metal complex, exudation, abnormal nasal diagnostic function, nasal anatomical disorder, metabolic disease, or congenital disease.
- Phone calls will measure children's adherence rate to treatment protocols, and participants determined to have treatment protocol adherence rates below 85% will be excluded.
Key Trial Info
Start Date :
March 3 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 6 2021
Estimated Enrollment :
101 Patients enrolled
Trial Details
Trial ID
NCT04752956
Start Date
March 3 2019
End Date
June 6 2021
Last Update
February 12 2021
Active Locations (2)
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1
Health Sciences University, Gülhane Training and Research Hospital, Gn. Dr. Tevfik Sağlam Cd No:11
Ankara, Etlik, Turkey (Türkiye), 06010
2
Gülhane Training and Research Hospital
Ankara, Turkey (Türkiye), 06010