Home » Trials » SLCTR/2020/027
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
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SLCTR Registration Number
SLCTR/2020/027
Date of Registration
The date of last modification
Nov 09, 2022
Trial Status
Scientific Title of 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
Public Title of 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
Disease or Health Condition(s) Studied
Allergic rhinitis
Scientific Acronym
None
Public Acronym
None
Brief title
None
Universal Trial Number
U1111-1261-3533
Any other number(s) assigned to the trial and issuing authority
2020/P/108 ERC Ruhuna
What is the research question being addressed?
Is oral montelukast more effective than cetirizine in the management of allergic Rhinitis in 6-12 -year -old children?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Double blinded : Participants, Investigators, Data analysts, Outcome assessors
Control
Active
Assignment
Parallel
Purpose
Treatment
Study Phase
Phase 4
Intervention(s) planned
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 given cetirizine 10mg at night for three months with dummy tablet of montelukast, and the other will be given montelukast 5 mg at night for three months with a dummy tablet of cetirizine. Dummy tablets will be prepared for both medications- Montelukast (Montiget) and cetirizine (Alerid) similar in color and morphology to its real tablet. Each dummy tablet will contain lactose and starch Both groups will receive 2 tablets at a time; the drug and the dummy.
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]
Primary outcome(s)
|
1.
1.Nasal symptom scored according to a four point Likert scale |
[ At the end of 3 months of starting treatment ] |
|
2.
2.Quality of life using the Pediatric Rhino conjunctivitis Quality of Life Questionnaire (PRQLQ) |
[ At the end of 3 months of starting treatment ] |
Secondary outcome(s)
|
1.
None |
[] |
Target number/sample size
176 (88 in each arm)
Countries of recruitment
Sri Lanka
Anticipated start date
2020-12-28
Anticipated end date
2021-06-18
Date of first enrollment
2021-01-01
Date of study completion
Recruitment status
Complete: follow up complete
Funding source
Getz Pharma (pvt) Ltd, Cipla Pharma Lanka, Astron Limited, Hilton Pharma
Regulatory approvals
Status
Approved
Date of Approval
2020-10-22
Approval number
2020/P/108
Details of Ethics Review Committee
| Name: | ERC, Faculty of Medicine, University of Ruhuna |
| Institutional Address: | ERC, Faculty of Medicine, University of Ruhuna P.O.Box70,Galle, Sri Lanka |
| Telephone: | +094-091-2232288 |
| Email: | ethics@med.ruh.ac.lk |
Contact person for Scientific Queries/Principal Investigator
Pushpika Prabashini Jayawardana
Senior Lecturer/ Pediatrician
Department of Pediatrics, Faculty of Medicine, University of Ruhuna, P.O.Box 70, Galle, Sri Lanka
+94 091 2246879
+94777901662
+094 091 2222314
pushpikaja@yahoo.com.au
Contact Person for Public Queries
Pushpika Prabashini Jayawardana
Senior Lecturer/ Pediatrician
Department of Pediatrics, Faculty of Medicine, University of Ruhuna, P.O.Box 70, Galle, Sri Lanka
+94 091 2246879
+94777901662
+094 091 2222314
pushpikaja@yahoo.com.au
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
No
IPD sharing plan description
Study protocol available
No
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
