Effectiveness of oral montelukast vs cetirizine in the management of allergic rhinitis in 6-12 -year -old children present to the asthma clinic at the Faculty of Medicine , University of Ruhuna. A randomized double blind controlled clinical trial

Phase 4

Conditions: Allergic rhinitis

Registration Number: SLCTR/2020/027

Lead Sponsor: Asthma clinic, Faculty of Medicine, University of Ruhuna

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete: follow up complete

Sex: Not specified

Target Recruitment: Not specified

Inclusion Criteria

* Age 6- 12 years

* Both male and female

* Having 3 out of 4 of the following for more than six months
[Sneezing, non purulent rhinorrhea, itchy nose, nasal congestion]

* Moderately severe- Defined as having one or more of the following items
[Sleep disturbance, Impairment of daily activities, leisure and/or sport, Impairment of school or work]

* Along with troublesome symptoms. [itchy eyes, Itchy nose, itchy throat, runny nose, blocked nose, sneezing, tearing/red eyes, mouth breathing]

Exclusion Criteria

* Those who had taken treatment for allergic rhinitis (either oral treatment over last 2 weeks or intranasal
treatment over the last 4 weeks)

* Deformities of the nasal passages

* Those who have undergone surgery in the upper airway.

* Children with mild symptoms of allergic rhinitis. Mild defined as the having none of the following items present:
[Sleep disturbance, Impairment of daily activities, leisure and/or sport, Impairment of school or work]

-Troublesome symptoms [itchy eyes, Itchy nose, itchy throat, runny nose, blocked nose, sneezing, tearing/red eyes, mouth breathing].

[Accompanied eye and ear symptoms of allergic rhino conjunctivitis or bronchial asthma or
eczema will not be excluded]

* Those who are on antacids and proton pump inhibitors (drug interactions)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Nasal symptom scored according to a four point Likert scale [At the end of 3 months of starting treatment]<br>2.Quality of life using the Pediatric Rhino conjunctivitis Quality of Life Questionnaire (PRQLQ) [At the end of 3 months of starting treatment]<br>

Secondary Outcome Measures