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IRCT2015061522531N2 IRCT 2015-08-20 Vice chancellor for research, Iran University of Medical Sciences Sُtudy of the theraputic effect of low dose aspirin on symptoms of chronic rhinosinusitis and nasal polyposis with aspirin sensitivity - Study of the theraputic effect of low dose aspirin on symptoms of chronic rhinosinusitis and nasal polyposis with aspirin sensitivity 2015-07-23 anticipated 60 Complete https://irct.ir/trial/19412 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: Balanced block randomization. 2 Chronic rhinosinusitis with nasal polyposis. Intervention 1: Intervention group1: aspirin desensitization and then perscription of aspirin with a daily dose of 325milligrams added to conventional treatment including intranasal beclomethasone one puff per nostril twice a day, nasal rinse with five milliliter of salin three times a day, 10 milligram montelukast tablet once daily, 10 milligram cetirizine tablet once daily, all for six months period. Intervention 2: Intervention group 2: Aspirin desensitization and then perscription of aspirin with a daily dose of 100 milligram added to conventional treatment including intranasal beclomethasone one puff per nostril twice a day, nasal rinse with five milliliter of salin three times a day, 10 milligram montelukast tablet once daily, 10 milligram cetirizine tablet once daily, all for six months period. Intervention 3: Control: Aspirin desensitization and then perscription of placcebo tablet once daily, for which the composition is the same as Aspirin tablet except for active aspirin material, added to conventional treatment including intranasal beclomethasone one puff per nostril twice a day, nasal rinse with five milliliter of salin three times a day, 10 milligram montelukast tablet once daily, 10 milligram cetirizine tablet once daily, all for six months period.
public Sima Shokri
Fourth floor, Building number one, Rasool-e-Akram hospital, Niayesh street, Sattarkhan Avenue.
Tehran Iran (Islamic Republic of) 1445613131 +98 21 6435 2383 dr.shokri.83@gmail.com Iran University of Medical Sciences scientific Mohamad Nabavi
Fourth floor, Building number one, Rasool-e-Akram hospital, Niayesh street, Sattarkhan Avenue.
Tehran Iran (Islamic Republic of) 1445613131 +98 21 6435 2383 nabavi.m@iums.ac.ir.com; mnabavi44@yahoo.com Iran University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria: age of 18-65 years; achieving a course of three months of conventional treatment before aspirin challenge; presence of symptoms of chronic rhinosinusitis with nasal polyposis confirmed by CT scan; Exclusion criteria: presence of any serious underlying disease including hemorrhagic; gastrointestinal; rheumatologic; malignant; cardiovascular; renal; hepatic and psychological disorders; history of IgE mediated reactions to aspirin or other non steroidal anti inflammatory drugs; first second expiratory volume of less than 70 percent of predicted at the time of aspirin challenge; pregnancy; nursing; use of topical or systemic beta blockers; warfarin and its derivates; Angiotensin converting enzyme inhibitors; patients with poor cooperation or treatment adherence; patients with carriers with high risk of trauma and accidents; 17 years 64 years Both J33.8 Other polyp of sinus Polyp of sinus: accessory ethmoidal maxillary sphenoida Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group1: aspirin desensitization and then perscription of aspirin with a daily dose of 325milligrams added to conventional treatment including intranasal beclomethasone one puff per nostril twice a day, nasal rinse with five milliliter of salin three times a day, 10 milligram montelukast tablet once daily, 10 milligram cetirizine tablet once daily, all for six months period Intervention group 2: Aspirin desensitization and then perscription of aspirin with a daily dose of 100 milligram added to conventional treatment including intranasal beclomethasone one puff per nostril twice a day, nasal rinse with five milliliter of salin three times a day, 10 milligram montelukast tablet once daily, 10 milligram cetirizine tablet once daily, all for six months period Control: Aspirin desensitization and then perscription of placcebo tablet once daily, for which the composition is the same as Aspirin tablet except for active aspirin material, added to conventional treatment including intranasal beclomethasone one puff per nostril twice a day, nasal rinse with five milliliter of salin three times a day, 10 milligram montelukast tablet once daily, 10 milligram cetirizine tablet once daily, all for six months period Severity of symptoms of chronic rhinosinusitis with nasal polyposis. Timepoint: before intervention, three months and six minths after intervention. Method of measurement: SinoNasal Outcome Test questionnaire and paranasa sinus CT scan. Complications of aspirin including gastrointestinal dyscomfort, epigastric pain or burning, nausea, vomitting, gastro intestinal bleeding, easy bruising, bleeding with minor trauma. Timepoint: before intervention, three and six months after intervention. Method of measurement: history taking and physical examination. Vice chancellor for research, Iran University of Medical Sciences Approved 2015-04-18 Iran University of Medical Sciences Fifth floor, Central Setad building, between Chamran and Sheikh Fazlollah Highway, Hemmat Highway, Iran University of Medical Sciences Tehran Iran (Islamic Republic of)