]>
IRCT201506079014N67 IRCT 2015-06-16 Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences Effect of local injection of botulinum toxin versus nasal fluticasone spray on clinical sign and symptoms in patients with allergic rhinitis Effect of local injection of botulinum toxin versus nasal fluticasone spray on clinical sign and symptoms in patients with allergic rhinitis: a triple blind randomized clinical trial 2015-06-22 anticipated 74 Complete https://irct.ir/trial/9506 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: Randomization: The patients will be randomly assigned to intervention and control groups using block randomization of 4 group. Blinding: Patients will be unaware of the type of intervention. The physician who will examine the patients will not be aware of the intervention. The analyzer will be unaware of the type of interventions. Therefore, the trial will be run as triple blind. 2 Allergic rhinitis. Intervention 1: Single dose injection of 50 unit Dysport dissolved in 0.1 ml normal saline in the frontal head of the inferior nasal turbinate in either side plus normal saline spray two puffs every 12 hours in either side of the nose for 8 weeks. Intervention 2: Single dose injection of 0.1 ml normal saline in the frontal head of the inferior nasal turbinate in either side plus normal saline spray two puffs every 12 hours in either side of the nose for 8 weeks.
public Dr Somayeh damadi
Besat Hospital, Shahed Square.
Hamadan Iran (Islamic Republic of) +98 81 3364 0030 somayedamadi@yahoo.com Besat Hospital scientific Dr Javaneh Jahanshahi
Besat Hospital, Shahed Square.
Hamadan Iran (Islamic Republic of) +98 81 3364 0030 j.jahanshahi@umsha.ac.ir Besat Hospital Iran (Islamic Republic of) Inclusion criteria: (a) age of 18 to 70 years; (b) having allergic rhinitis. Exclusion criteria: (a) pregnancy or breastfeeding; (b) contraindication of corticosteroids; (c) having severe anatomical abnormality in nose or acute rinosinusitis; (d) having glaucoma or prostatic hypertrophy; (e) having severe systemic diseases such as diabetes or asthma; (f) simultaneous using aminoglycoside drugs. 8 years 70 years Both J30.4 Allergic rhinitis, unspecified Treatment - Drugs Placebo Single dose injection of 50 unit Dysport dissolved in 0.1 ml normal saline in the frontal head of the inferior nasal turbinate in either side plus normal saline spray two puffs every 12 hours in either side of the nose for 8 weeks. Single dose injection of 0.1 ml normal saline in the frontal head of the inferior nasal turbinate in either side plus normal saline spray two puffs every 12 hours in either side of the nose for 8 weeks. Assessing nasal congestion. Timepoint: 8 weeks after intervention. Method of measurement: through physical examination. Assessing rhinorrhea. Timepoint: 8 weeks after intervention. Method of measurement: through taking history. Assessing nasal itching. Timepoint: 8 weeks after intervention. Method of measurement: through taking history. Assessing sneezing. Timepoint: 8 weeks after intervention. Method of measurement: through taking history. Assessing dizziness. Timepoint: 8 weeks after intervention. Method of measurement: through taking history. Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences Approved 2015-05-26 Ethic Committee of Hamadan University of Medical Sciences Vice-chancellor of Research the Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave Hamadan Iran (Islamic Republic of)