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IRCT20230127057244N3 IRCT 2024-12-29 Tehran University of Medical Sciences A comparative study of injecting platelet-rich plasma solution versus normal saline injection on olfactory outcomes following endoscopic sinus surgery in patients with chronic sinusitis accompanied by nasal polyps. A comparative randomized study of injecting platelet-rich plasma solution versus normal saline injection on olfactory outcomes following endoscopic sinus surgery in patients with chronic sinusitis accompanied by nasal polyps : a single-center clinical trial 2025-01-20 anticipated 40 Complete https://irct.ir/trial/79306 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not 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: In this study, a single-blind method is used. This means that the patient is aware of their participation in the study but will not be informed about the type of intervention, whether it is normal saline or platelet-rich plasma. However, the physician and the principal investigator are aware of the type of injected substance and the selected individuals. 3 Chronic Sinusitis. Intervention 1: Intervention group: Injection of platelet-rich plasma solution on olfactory outcome after endoscopic sinus surgery in sick patients to chronic sinusitis with polyps. Intervention 2: Control group: Normal saline injection on olfactory outcome following endoscopic sinus surgery in patients with chronic sinusitis with polyps. 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) Patients aged 15 to 50 years with nasal polyps. 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 Truma Revision Sinonasal Surgery Smoking Congenital Anosmia Systemic Disorder J32.4 Chronic pansinusitis Treatment - Drugs Treatment - Drugs Intervention group: Injection of platelet-rich plasma solution on olfactory outcome after endoscopic sinus surgery in sick patients to chronic sinusitis with polyps Control group: Normal saline injection on olfactory outcome following endoscopic sinus surgery in patients with chronic sinusitis with polyps. Olfactory Outcomes. Timepoint: At entrance time to trial and 6 months later. Method of measurement: Sino-nasal Outcome Test. Tehran University of Medical Sciences Tehran University of Medical Sciences Tehran University of Medical Sciences Approved 2024-04-20 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)