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IRCT20230127057244N2 IRCT 2024-12-27 Tehran University of Medical Sciences comparing the Effect of corticosteroids and PRP on anosemia with placebo comparing the effects of injecting a mixture of corticosteroids and platelet-rich plasma in the olfactory cleft of patients with nasal polyposis on the improvement of anosemia after endoscopic sinus surgery and comparing it with placebo. 2025-01-20 anticipated 56 Complete https://irct.ir/trial/78302 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The random allocation of patients into two groups is done by the stratified block randomization method. In such a way that first the eligible patients are referred in the order of entry They are classified according to age and sex. Then based on blocks of 4 (consisting of two groups A and B and two repetitions for each) that are randomly selected from among all the possible cases of permutations and assigned to the desired group they find These blocks were created using the statistical software R version 4.0.2, Blinding description: Patients participating in the project will be blinded to receiving medicine or placebo.the injection will be done during general anestesia. 3 Chronic Sinusitis. Intervention 1: Intervention group:Injection of a mixture of one cc platelet-rich plasma solution obtained from centrifugation of patients' blood samples and in one cc triamcinolone from Iran Hormon Pharmaceutical Company in the olfactory cleft area of ​​the patients in a space of one centimeter in patients with chronic sinusitis with polyps who have undergone endoscopic sinus surgery. This procedure will be performed at the end of the surgery and will not be repeated. Intervention 2: Control group: Injecting one cc of normal saline from Iran Injectable and Pharmaceutical Products Company following endoscopic sinus surgery in the olfactory cleft area of ​​patients in a space of one centimeter in patients with chronic sinusitis with polyps who have undergone endoscopic sinus surgery. This procedure will be performed at the end of the surgery and will not be repeated. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information.
public MohammadReza Firozifar
Amir Alam hospital ENT clinic, North Saadi St., Enghelsb Ave.
Tehran Iran (Islamic Republic of) 1145765111 +98 21 6670 6106 mrfirouzifar@sina.tums.ac.ir Tehran University of Medical Sciences scientific Mohammadreza Firouzifar
Amiralam Hospital North Saadi Enghelab st.
Tehran Iran (Islamic Republic of) 1145765111 +98 21 6670 3037 mrfirouzifar@sina.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Nasal polyposis , Having different severities of olfactory disorder based on the olfactory recognition test score and duration of anosmia less than 2 years. 15 years 50 years Both Head trauma Prior sinus surgery Somking more than 20 pack:year in last year Systemic disease like parkinsone and alzheimer DRAF3 or 2b J32.4 Chronic pansinusitis Treatment - Drugs Treatment - Drugs Intervention group:Injection of a mixture of one cc platelet-rich plasma solution obtained from centrifugation of patients' blood samples and in one cc triamcinolone from Iran Hormon Pharmaceutical Company in the olfactory cleft area of ​​the patients in a space of one centimeter in patients with chronic sinusitis with polyps who have undergone endoscopic sinus surgery. This procedure will be performed at the end of the surgery and will not be repeated. Control group: Injecting one cc of normal saline from Iran Injectable and Pharmaceutical Products Company following endoscopic sinus surgery in the olfactory cleft area of ​​patients in a space of one centimeter in patients with chronic sinusitis with polyps who have undergone endoscopic sinus surgery. This procedure will be performed at the end of the surgery and will not be repeated. Olfactory Outcomes. Timepoint: before intervention and 6 month after. Method of measurement: I_SIT Score. Tehran University of Medical Sciences Tehran University of Medical Sciences Tehran University of Medical Sciences Approved 2024-06-30 Research Ethics Committees of School of Medicine- Tehran University of Medical Sciences Tehran University of Medical Sciences, Vice Chancellor for Research and Technology, Ghods St., Keshavarz Blvd Tehran Tehran Iran (Islamic Republic of)