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IRCT20221206056721N1 IRCT 2023-01-22 Kerman University of Medical Sciences Effect of Tacrolimus drop in Nasal Polyp Recurrence Evaluation of the effect of Tacrolimus drop in preventing the recurrence of nasal polyps in patients with chronic rhinosinusitis after endoscopic sinus surgery 2023-01-08 anticipated 20 Complete https://irct.ir/trial/67940 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization method: simple randomization Using random allocation software, patients were randomly assigned to one of two intervention and control groups, Blinding description: Participants (patients who are candidates for surgery due to chronic rhinosinusitis with polyps), clinical caregivers In both groups, in the form of drops with the same shape, color and dosage for 9 months, so that patients and doctors will be unaware of how the drops are allocated to the intervention and control groups, and the drops will be numbered, which only the data analyzer will know about the numbering. N/A Condition 1: Nasal polyps. Condition 2: Chronic rhino sinusitis. Intervention 1: Intervention group: In the intervention group, tacrolimus 0.03% topical drops are prescribed. These drugs are continued daily until the end of the study (9 months). Patients who are treated with tacrolimus drops, if they experience side effects and sensitivity during the first, third and seventh days after the start of treatment, they will be excluded from the study and treated with steroid drops. It should be noted that Prograf ampoules (5mg/1ml) are used to make tacrolimus drops. In this formulation, 3 ampoules with a volume of 3 ml containing 15 mg of tacrolimus are mixed with 47 ml of sterile phosphate buffer and the resulting solution is divided into sterile 5 ml drop containers and will be available to patients. These drops should be stored in a refrigerator at a temperature of 4 degrees Celsius. Intervention 2: Control group: In the control group, betamethasone corticosteroid drops (manufacturer of Sinadaro) are prescribed (routine and usual treatment). These drugs will be continued daily (5 drops every morning) until the end of the study (9 months). Patients who are treated with tacrolimus drops, if they experience side effects and allergies during the first, third and seventh days after the start of treatment, they will be excluded from the study and treated with corticosteroid drops (betamethasone). No - There is not a plan to make this available Justification or reason for not sharing IPD is here is no further information
public Mohammad Jalali
Shafa Hospital
Kerman Iran (Islamic Republic of) 7618751151 +98 34 3212 4727 drmjalali01@yahoo.com Kerman University of Medical Sciences scientific mohammad jalali
Shafa Hospital
Kerman Iran (Islamic Republic of) 7618751151 +98 34 3212 4727 drmjalali01@yahoo.com Kerman University of Medical Sciences Iran (Islamic Republic of) Patients referred to Shafa Kerman Hospital in 1401 who are candidates for surgery due to chronic rhinosinusitis with polyps (patients who have not responded to common treatments including broad-spectrum antibiotics, inhaled steroids, and short-term courses of oral steroids) Informed consent to enter the study 18 years no limit Both Age less than 18 years Suffering from genetic diseases including Ciliary Dyskinesia or Cystic Fibrosis Recurrence of polyps less than 3 months after surgery Patients who were in the intervention group and showed sensitivity to tacrolimus drops. Patients who did not refer for follow-up Lack of informed consent to enter the study J33.0 J32.9 Polyp of nasal cavity Chronic sinusitis, unspecified Treatment - Drugs Treatment - Drugs Intervention group: In the intervention group, tacrolimus 0.03% topical drops are prescribed. These drugs are continued daily until the end of the study (9 months). Patients who are treated with tacrolimus drops, if they experience side effects and sensitivity during the first, third and seventh days after the start of treatment, they will be excluded from the study and treated with steroid drops. It should be noted that Prograf ampoules (5mg/1ml) are used to make tacrolimus drops. In this formulation, 3 ampoules with a volume of 3 ml containing 15 mg of tacrolimus are mixed with 47 ml of sterile phosphate buffer and the resulting solution is divided into sterile 5 ml drop containers and will be available to patients. These drops should be stored in a refrigerator at a temperature of 4 degrees Celsius. Control group: In the control group, betamethasone corticosteroid drops (manufacturer of Sinadaro) are prescribed (routine and usual treatment). These drugs will be continued daily (5 drops every morning) until the end of the study (9 months). Patients who are treated with tacrolimus drops, if they experience side effects and allergies during the first, third and seventh days after the start of treatment, they will be excluded from the study and treated with corticosteroid drops (betamethasone). Lund-Kennedy Score. Timepoint: Patients of both groups were followed up at intervals of 3 months, 6 months, and 9 months after surgery, and the Lund-Kennedy score was calculated during endoscopic examination. Method of measurement: Method of measurement: endoscopy and unit of measurement: score. Lund-Mckay score. Timepoint: Patients of both groups underwent follow-up at intervals of 3 months, 6 months, and 9 months after surgery. Method of measurement: Method of measurement: CT Scan and unit of measurement: score. Kerman University of Medical Sciences Approved 2023-01-16 Ethics Committee of Kerman University of Medical Scieces Hospital Shafa, Kerman University of Medical Sciences Kerman Kerman Iran (Islamic Republic of)