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IRCT20200825048515N50 IRCT 2021-12-26 Esfahan University of Medical Sciences Comparative study of the effectiveness of "Intraconazole with fluticasone", "Doxycycline with fluticasone", and "Fluticasone spray alone" in the treatment of chronic rhinosinusitis Comparative study of the effectiveness of "Intraconazole with fluticasone", "Doxycycline with fluticasone", and "Fluticasone spray alone" in the treatment of chronic rhinosinusitis with nasal polyp 2022-01-21 anticipated 108 Complete https://irct.ir/trial/60826 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, 108 eligible patients are randomly selected. For this, the letter A is written on 36sheets, the letter B is written on 36 sheets, and the letter C is written on 36sheets and each of them is placed in an envelope. Each patient is then asked to choose one of the envelopes. Depending on the selected envelope, the patient is assigned to one of three groups, Blinding description: Due to the variety of treatment interventions, the specialist physician is aware of the prescription of each medication. But patients will not know what kind of spray, that they use. In addition, the person recording the clinical and baseline information of the patients as well as the statistical analyst will not be aware of the type of intervention. 2 Chronic rhinosinusitis. Intervention 1: Intervention group 1: Patients in this group will receive doxycycline 100 mg twice a day, along with flomist spray intranasally (one puff per nostril every 12 hours). Intervention 2: Intervention group 2: Patients in this group will receive only flomist spray intranasally (one puff per nostril every 12 hours). Intervention 3: Intervention group 3: Patients in this group will receive two capsules of itraconazole 100 mg daily in divided doses, along with flomist spray intranasally (one puff in each nostril every 12 hours). No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Sayed Mostafa Hashemi
Kashani Street
Isfahan Iran (Islamic Republic of) 8183983414 +98 31 3233 0091 mostafa_hashemi@med.mui.ac.ir Esfahan University of Medical Sciences scientific Sayed Mostafa Hashemi
Kashani Street
Isfahan Iran (Islamic Republic of) 8183983414 +98 31 3233 0091 mostafa_hashemi@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Age 65-15 years Having chronic rhinosinusitis More than 6 months history of chronic rhinosinusitis Do not take medication to control chronic rhinosinusitis in a recent month Satisfaction to participate in the study 15 years 65 years Both Having diabetes Having endocrine and metabolic diseases Having Immune deficiency diseases Allergy to the studied drugs Incidence of hepatic complications due to intraconazole J32 Chronic sinusitis Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group 1: Patients in this group will receive doxycycline 100 mg twice a day, along with flomist spray intranasally (one puff per nostril every 12 hours). Intervention group 2: Patients in this group will receive only flomist spray intranasally (one puff per nostril every 12 hours). Intervention group 3: Patients in this group will receive two capsules of itraconazole 100 mg daily in divided doses, along with flomist spray intranasally (one puff in each nostril every 12 hours). Symptoms of chronic rhinosinusitis. Timepoint: Before and after the intervention. Method of measurement: Twenty-two-item Sino-Nasal Outcome Test (SNOT-22). Isfahan University of Medical Sciences Approved 2020-11-10 Ethics committee of Isfahan University of Medical Sciences Street address Isfahan University of Medical Sciences, Hezar Jarib Ave., Azadi Sq Isfahan Isfehan Iran (Islamic Republic of)