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IRCT201208261579N3 IRCT 2012-10-03 Vice Chancellor for Research, Isfahan University of Medical Sciences Botulinum Toxin-A Compared with Cetirizine in the Treatment of Allergic Rhinitis Evaluating the Effects of Intranasal Injection of Botulinum Toxin-A Compared with Cetirizine on Symptoms of Rhinitis in Adult Patients with Allergic Rhinitis 2010-12-23 anticipated 50 Complete https://irct.ir/trial/986 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: Patients were randomized to the groups based on random table numbers generated by random allocation software. 2 Allergic rhinitis. Intervention 1: Intervention: Patients in the intervention group were treated with a single dose intranasal injection of BTX-A (Dysport, Ipsen Biopharm, Wrexham, UK). The procedure was applied while the patients were in sitting position. Local intranasal anesthesia was done with 10% lidocaine sprayed 10 minutes before the injection. Each vial of 495 IU BTX-A was diluted with 3.3 cc of distilled water (150 IU/cc), and 0.5 cc (75 IU each nasal cavity) of this solution was slowly injected with insulin needle into the anterior part of each inferior turbinate. Intervention 2: Control: Patients in the control group were treated with cetirizine (Abidi Co., Tehran, IRAN) 10 mg once daily for two months.
public Dr. Saghi Amini
Department of Otorhinolaryngology Head and Neck surgery, Alzahra Hospital, Soffeh Ave.
Isfahan Iran (Islamic Republic of) 00 drsaghi210@hotmail.com Isfahan University of Medical Sciences scientific Dr. Saghi Amini
Department of Otorhinolaryngology Head and Neck surgery, Alzahra Hospital, Soffeh Ave.
Isfahan Iran (Islamic Republic of) 00 drsaghi210@hotmail.com Isfahan University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria: 1- Adult patients with allergic rhinitis according to the Allergic Rhinitis and its Impact on Asthma criteria, 2- Having at least three symptoms of sneezing, nasal congestion, and rhinorrhea. Exclusion criteria: 1- History of nasal anatomic abnormality, 2- Persistent asthma, 3- Long term use of systemic corticosteroids, 4- Malignancy, tuberculosis, diabetes mellitus, or other chronic systemic disease, 5- History of rhinoplasty, 6- Pregnant women, 7- Being on local corticosteroids at the time of enrollment. 18 years 65 years Both J30 Vasomotor and allergic rhinitis Treatment - Drugs Treatment - Drugs Intervention: Patients in the intervention group were treated with a single dose intranasal injection of BTX-A (Dysport, Ipsen Biopharm, Wrexham, UK). The procedure was applied while the patients were in sitting position. Local intranasal anesthesia was done with 10% lidocaine sprayed 10 minutes before the injection. Each vial of 495 IU BTX-A was diluted with 3.3 cc of distilled water (150 IU/cc), and 0.5 cc (75 IU each nasal cavity) of this solution was slowly injected with insulin needle into the anterior part of each inferior turbinate. Control: Patients in the control group were treated with cetirizine (Abidi Co., Tehran, IRAN) 10 mg once daily for two months. Sneezing. Timepoint: Baseline and every two weeks for two months. Method of measurement: Allergic Rhinitis and its Impact on Asthma Questionnaire. Rhinorrhea. Timepoint: Baseline and every two weeks for two months. Method of measurement: Allergic Rhinitis and its Impact on Asthma Questionnaire. Nasal congestion. Timepoint: Baseline and every two weeks for two months. Method of measurement: Allergic Rhinitis and its Impact on Asthma Questionnaire. Nasal itching. Timepoint: Baseline and every two weeks for two months. Method of measurement: Allergic Rhinitis and its Impact on Asthma Questionnaire. Eye irritation. Timepoint: Baseline and every two weeks for two months. Method of measurement: Allergic Rhinitis and its Impact on Asthma Questionnaire. Quality of life. Timepoint: Before and two months after the study. Method of measurement: Rhinasthma Questionnaire. Nasal dryness. Timepoint: Every two weeks for two months. Method of measurement: Interview with patient. Epistaxis. Timepoint: Every two weeks for two months. Method of measurement: Interview with patient. Sleepiness. Timepoint: Every two weeks for two months. Method of measurement: Interview with patient. Blurred vision. Timepoint: Every two weeks for two months. Method of measurement: Interview with patient. Vice Chancellor for Research, Isfahan University of Medical Sciences Approved 2010-12-23 The Ethics Committee of Isfahan University of Medical Sciences Hezar Jarib Street, Vice Chancellor for Research, Isfahan University of Medical Sciences Isfahan Iran (Islamic Republic of)