Protocol summary

Study aim
Determining the effects of washing the nose with normal saline in the treatment of allergic rhinitis in children 6 to 12
Design
Randomized Clinical trial with control group, two parallel groups, children with allergic rhinitis aged 12–6 years divided two groups by block randomization method using Random allocation software
Settings and conduct
A study on children with allergic rhinitis referred to Urmia University of Medical Sciences' allergy clinics will be conducted, which will be randomly assigned to one of the two groups. The control group receives standard treatment (including oral antihistamine (1citrizine every 2 hours) and intranasal corticosteroids (Mometasone) every 12 hours), and the second group, in addition to standard treatment, nasal washes 4 times a day with a saline-soluble .65 % solution. Signs such as sneezing, nasal runaway, nasal itching, nasal obstruction, itching palate, eye symptoms, and disruption to the daily activity and sleep of the patients will be collected before starting treatment and at intervals of one and three months using the RQLQ questionnaire.
Participants/Inclusion and exclusion criteria
Inclusion criteria: children with allergic rhinitis aged 12–6 years Parental Informed consent to participate in the study Exclusion criteria: Non-allergic rhinitis, adenoid enlargement, infectious rhinitis, Concha Bollusa, intranasal meningocele, nasal polyp
Intervention groups
The control group receives standard treatment (including oral antihistamine (1citrizine every 2 hours) and intranasal corticosteroids (Mometasone) every 12 hours), and the second group, in addition to standard treatment, nasal washes 4 times a day with a saline-soluble .65 % solution.
Main outcome variables
Sneezing, nasal runaway, nasal itching, nasal obstruction, itching palate, eye symptoms, and disruption to the daily activity and sleep using the RQLQ questionnaire.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20150426021944N4
Registration date: 2023-04-08, 1402/01/19
Registration timing: registered_while_recruiting

Last update: 2023-04-08, 1402/01/19
Update count: 0
Registration date
2023-04-08, 1402/01/19
Registrant information
Name
Hamidreza Houshmand
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3231 7288
Email address
hamidreza.houshmnd@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-04, 1402/01/15
Expected recruitment end date
2023-08-06, 1402/05/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effects of nasal lavage with normal saline in the treatment of allergic rhinitis in children 6 to 12 years old refers to allergic clinics of Urmia university of medical science
Public title
Evaluation of the effects of nasal lavage with normal saline in the treatment of allergic rhinitis in children
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Allergic rhinitis Age 6-12 year Parents consent to participate in the study
Exclusion criteria:
Enlargement of Adenoids Infectious rhinitis Concha Bollusa Myelomeningocele Nasal polyps
Age
From 6 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 96
Randomization (investigator's opinion)
Randomized
Randomization description
The allocation of individuals into the two groups will be used by the blocked randomization method. For this method, blocks will first be created with a size equal to 6 and a combination of AAA BBB and then all possible combinations will be created and listed, and then each combination of a data assignment code will be created. It will, according to the sample size (n=96) and the block size (6), randomly select 16 blocks, all of these steps will be performed under the supervision of an epidemiologist consultant using Random Allocation Software.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Urmia University of Medical Sciences
Street address
Vice Chancellor for Research, UMSU Central Site, Orjhans Street, Resalat Blvd, Urmia ,Iran
City
ارومیه
Province
West Azarbaijan
Postal code
5714783734
Approval date
2023-01-07, 1401/10/17
Ethics committee reference number
IR.UMSU.REC.1401.354

Health conditions studied

1

Description of health condition studied
allergic rhinitis
ICD-10 code
J30
ICD-10 code description
Vasomotor and allergic rhinitis

Primary outcomes

1

Description
PRQLQ (The Pediatric Rhinoconjunctivitis Quality of Life Questionnaire)
Timepoint
Before, one and three month after intervention
Method of measurement
PRQLQ questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: receives standard treatment (including oral antihistamine (1citrizine every 2 hours) and intranasal corticosteroids (mometasone) every 12 hours), and nasal wash 4 times a day with a saline-soluble .65 % solution
Category
Treatment - Drugs

2

Description
Control group: receives standard treatment (including oral antihistamine (1citrizine every 2 hours) and intranasal corticosteroids (mometasone) every 12 hours)
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Allergi clinic of Urmia university of medical sciences
Full name of responsible person
Hamid reza Hoshmand
Street address
Kasahni Ave. Motahhari Hospital
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3223 7077
Email
hamidrezahoushmand1347@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Dr. Saber Gholizadeh
Street address
Vice Chancellor for Research, UMSU Central Site, Orjhans Street, Resalat Blvd, Urmia ,Iran
City
ارومیه
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3193 7224
Email
research@umsu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Oroumia University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Hanid-Reza Hoshmand
Position
Assosiate professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Kashani Ave. Motahari Hospital
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3223 7077
Email
hamidrezahoushmand1347@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Hanid-Reza Hoshmand
Position
Assosiate professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Kashani Ave. Motahari Hospital
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3223 7077
Email
hamidrezahoushmand1347@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Bita Yadeghari
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Kashani Ave. Motahari Hospital
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3223 7077
Email
bita.yadegari@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
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