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Studying a Natural Relief for Children with Allergies and Asthma

Investigation of the effectiveness of using 0.65% sodium chloride nasal spray in children aged 6 to 18 years with allergic rhinitis and asthma

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
IRCT
Registry ID
IRCT20150426021944N6
Enrollment
68
Registered
2025-09-22
Start date
2025-09-23
Completion date
Unknown
Last updated
2025-10-13

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

Conditions

Allergic rhinitis in children, with or without comorbid asthma. Vasomotor and allergic rhinitis

Interventions

Intervention 1: Intervention group: Participants receive 0.65% sodium chloride nasal spray (isotonic saline) in addition to routine care (cetirizine, montelukast, or seroflo as clinically indicated).

Sponsors

Oroumia University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
6 Years to 18 Years

Inclusion criteria

Inclusion criteria: Age 6 to 18 years Diagnosis of moderate to severe allergic rhinitis according to the ARIA 2019 guidelines and an allergist with typical symptoms including sneezing, clear nasal discharge, nasal congestion, and nasal itching Diagnosis of moderate to severe asthma based on spirometry (FEV1/FVC ratio less than 60% and =12% improvement in FEV1 with an absolute increase of =200 ml after salbutamol administration) Written parental consent to participate in the study No diagnosis of cardiac or pulmonary diseases other than asthma, chronic pneumonia, and immunodeficiency No non-allergic nasal congestion such as non-allergic rhinitis, nasal polyps, deviated septum, and concha bullosa

Exclusion criteria

Exclusion criteria: Disagreement to continue participating in the study Development of new diseases affecting the treatment process during the study Bleeding or other complications during treatment Sensitivity to the medication or any medical condition that requires discontinuation of treatment

Design outcomes

Primary

MeasureTime frame
Change in Total Nasal Symptom Score (TNSS) in children with allergic rhinitis. Timepoint: Measured at baseline (before intervention) and after 4 weeks of intervention. Method of measurement: Standardized Total Nasal Symptom Score (TNSS) questionnaire.

Secondary

MeasureTime frame
Change in asthma severity score. Timepoint: Baseline (before intervention), 2 weeks, and 4 weeks after intervention. Method of measurement: Pediatric Asthma Severity Score, assessed by standardized clinical examination and history (including wheeze, use of accessory respiratory muscles, and expiratory prolongation) using a structured data collection form.

Countries

Iran (Islamic Republic of)

Contacts

Public Contact??Dr. Hamid Reza Houshmand

Oroumia University of Medical Sciences

hamidreza.houshmand@gmail.com0098 44 3334592

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026