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Study aim:
Evaluation and comparison of the efficacy of Cromolyn sodium , Mometazone, and Azelastin in improving nasal symptoms in patients with moderate to severe persistent Allergic Rhinitis.
Design:
A Phase 2, randomized, double blind, parallel-group, controlled clinical trial involving 108 patients; Random Allocation software was used for randomization.
Settings and conduct:
Patient symptoms are assessed and scored using the Total Nasal Symptom Score (TNSS). This questionnaire comprises four components nasal congestion, rhinorrhea, sneezing, and nasal itching each scored from 0 to 3 based on symptom severity, resulting in a total score ranging from 0 to 12. Patients will be evaluated on two occasions: day one (prior to initiating medication) and day twenty-eight (after starting medication); necessary information will be collected from the patients and recorded on data forms. Matching for age and sex will be performed, and the study will be conducted in a double-blind manner using identical spray containers prepared by a pharmacist and assigned to three groups ;ensuring that neither the administrator nor the patient is aware of the specific spray type. The study will be conducted at the Al-Zahra ENThospital in Zahedan.
Participants/Inclusion and exclusion criteria:
Inclusion criteria: patients with a confirmed diagnosis of Allergic Rhinitis; age 18–50 years; moderate-to-severe Allergic Rhinitis based on symptom severity; and provision of written informed consent to participate in the study.
Intervention groups:
For Sodium Cromoglicate, the dosage is one spray in each nostril, four times daily; For Azelastin, is one spray in each nostril, twice daily; For Mometazone is one spray in each nostril, twice daily.
Main outcome variables:
Recipients of mometasone spray in the control group are compared with recipients of azelastine and cromolyn sodium sprays regarding their response to treatment.