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IRCT20150426021944N6 IRCT 2025-09-22 Oroumia University of Medical Sciences Studying a Natural Relief for Children with Allergies and Asthma SNS-ARAS Investigation of the effectiveness of using 0.65% sodium chloride nasal spray in children aged 6 to 18 years with allergic rhinitis and asthma 2025-09-23 anticipated 68 Complete https://irct.ir/trial/86217 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, randomization was carried out using a simple randomization method with an equal 1:1 allocation ratio between the intervention group and the control group. The unit of randomization was the individual participant, specifically children aged 6–18 years who met the inclusion criteria. The randomization sequence was generated electronically through Randomization.com, a computer-based tool designed for clinical trials. The sequence was created in advance, with assignments prepared in a simple random list, ensuring that each eligible participant had an equal probability of being allocated to either group. During enrollment, participants were assigned sequentially according to the pre-generated list. This approach ensured a straightforward allocation process, though the document does not specify the use of stratification, blocking, or other pseudorandomization techniques. The study was conducted in a double-blind manner, meaning both participants and outcome assessors were unaware of group assignments, and a placebo spray was used to preserve masking, Blinding description: In this trial, participants were blinded by the use of indistinguishable nasal sprays, with the intervention group receiving 0.65% sodium chloride spray and the control group receiving a placebo spray. The sprays were identical in appearance, packaging, and method of administration, ensuring that participants could not determine their group assignment. Healthcare providers (caregivers delivering the intervention and routine care) were also blinded, since they administered sprays that were identical in form and labeling, and thus could not differentiate between treatment and placebo. The principal investigators and study team responsible for trial oversight remained blinded to allocation throughout participant enrollment and follow-up, thereby preventing any intentional or unintentional bias in patient management or trial conduct. Outcome assessors, who collected symptom scores, quality-of-life measures, and asthma severity indices, were blinded to group allocation, ensuring that clinical assessments and data collection were unbiased. While the data collectors overlapped with outcome assessors and thus remained blinded, the data analysts were not explicitly reported as blinded in the protocol; therefore, it is likely that they had access to group allocation codes during statistical analysis. No Data Safety and Monitoring Board (DSMB) was established for this small investigator-initiated academic study, as DSMBs are typically reserved for large-scale or industry-sponsored trials. Finally, manuscript writers were members of the investigator team and therefore were not independent or blinded at the stage of report preparation. 4 Allergic rhinitis in children, with or without comorbid asthma. 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). The spray is administered intranasally at the prescribed daily dose for 4 weeks. Intervention 2: Control group: Received routine treatment plus placebo instead of decosalin. Yes - There is a plan to make this available What will be shared: “Deidentified Individual Participant Data (IPD) set; Study Protocol; Statistical Analysis Plan; Informed Consent Form (template); Data Dictionary.” The IPD will include deidentified baseline characteristics and all outcome measures collected during the trial. The protocol and statistical analysis plan will be the final versions used for the study. The informed consent form will be the final approved template (with personal/contact fields redacted). The data dictionary will define each variable, units, coding, and allowable ranges. When: Beginning 6 months after publication of the primary results and continuing for 5 years thereafter. To whom: Qualified researchers from academic or non-profit institutions with a methodologically sound proposal. Industry researchers may also apply if the request aligns with the consent and ethical approvals. Conditions: Access will be granted for analyses addressing the research questions described in an approved proposal, contingent on: (1) submission of a brief protocol and analysis plan, (2) evidence of local ethics approval or exemption, (3) signing a Data Use Agreement prohibiting re-identification, unauthorized sharing, and commercial use, and (4) approval by the Data Access Committee (Principal Investigator plus two co-investigators). Data will be provided deidentified via a secure, time-limited link. Where to obtain: Dr.Hamidreza Houshmand How to obtain: Submit a request including a one-page proposal (objectives, variables requested, analysis plan), proof of ethics approval/exemption, and a signed confidentiality statement. The Data Access Committee will review within ~30 days. If approved, a Data Use Agreement will be issued for signature; upon execution, deidentified data and documents will be shared via secure transfer within ~10 business days. Comments:
public ِِDr. Hamid Reza Houshmand
Kashani street
Orumia Iran (Islamic Republic of) 57159-74677 0098 44 3334592 hamidreza.houshmand@gmail.com Oroumia University of Medical Sciences scientific ِِDr. Hamid Reza Houshmand
Kashani Street
Orumia Iran (Islamic Republic of) 57159-74677 0098 44 3334592 hamidreza.houshmand@gmail.com Oroumia University of Medical Sciences Iran (Islamic Republic of) 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 6 years 18 years Both 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 J30 Vasomotor and allergic rhinitis Treatment - Drugs Placebo Intervention group: Participants receive 0.65% sodium chloride nasal spray (isotonic saline) in addition to routine care (cetirizine, montelukast, or seroflo as clinically indicated). The spray is administered intranasally at the prescribed daily dose for 4 weeks. Control group: Received routine treatment plus placebo instead of decosalin. 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. 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. Oroumia University of Medical Sciences Approved 2025-08-27 Ethics Committee of Urmia University of Medical Sciences Vice Chancellor for Research, UMSU Central Site, Orjhans Street, Resalat Blvd, Urmia ,Iran Urmia West Azarbaijan Iran (Islamic Republic of)