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

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

SLCTR

Registry ID

SLCTR/2020/027

Enrollment

Unknown

Registered

2020-12-28

Start date

2020-12-28

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allergic rhinitis

Interventions

The study will be done at the Asthma clinic, Faculty of Medicine, University of Ruhuna. Participants will be randomized to two groups using computer generated block randomizing. One group will be give

the drug and the dummy.

Eligibility

Inclusion criteria

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

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)

Design outcomes

Primary

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

Secondary

Measure	Time frame
None []	—

Countries

Sri Lanka

Contacts

Public ContactPushpika Prabashini Jayawardana

Senior Lecturer/ Pediatrician

pushpikaja@yahoo.com.au+94 091 2246879

Outcome results

None listed

Source: SLCTR (via WHO ICTRP) · Data processed: Aug 9, 2026