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IRCT20200211046464N1 IRCT 2020-05-04 Shahid Beheshti University of Medical Sciences Effect of PRP in treatment of anosmia Evaluation the effectiveness of platelet-rich plasma in smell Improvement of Patients with nasal polyposis due to chronic sinusitis 2017-09-23 anticipated 24 Complete https://irct.ir/trial/47132 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block Random assignment, Blinding description: The patients are unaware of the type of intervention performed during general anesthesia and the technician who evaluates the outcome is not present during the surgical procedure. Surgeon in charge of injection. 3 Condition 1: Nasal Polyp. Condition 2: Anosmia. Intervention 1: Intervention group: Patients in both groups underwent sinus endoscopic surgery by only one specific ENT specialist. At this stage, in the intervention group, a platelet-rich plasma was injected into the patient's nose inside the operating room and during general anesthesia. To do this, platelet-rich plasma was injected with a 1 cc syringe in the olfactory area within 1 cm2 with the help of a nasal endoscope and by the same surgeon from specific ENT specialists. The whole process of preparing platelet-rich plasma was performed in the sports medicine group under the supervision of the sports medicine professor and using Arjangian platelet-rich plasma kits. The temperature during these steps to prevent plaque clots was 21-24. C. Intervention 2: Control group:After Functional endoscopic sinus surgery, in the control group, instead of platelet-rich plasma, normal saline serum was injected into the patient's olfactory area with the same amount and under the same conditions. The injector was also unaware of the group of patients and the injected substance. Yes - There is a plan to make this available What will be shared: Information about the main outcome after not identifying individuals When: 6 months after printing the results To whom: Researchers working in academic and scientific institutions Conditions: Scientific research in academic institutions Where to obtain: Ali Goljanian Tabrizi; Ali.goljanian@gmail.com Mahboobeh Asadi Amiri; Mahboobeh_farvardin@yahoo.com How to obtain: State the name, academic or professional rank, the applicant center and the reason for the application in your email. Files and documents will be sent about 1 month after the request is processed. Comments:
public Mehdi Mohammadi
floor 2., No. 11, Mohammadi Rd., East Kourosh St., North Janat Abad Blvd
Tehran Iran (Islamic Republic of) 1477835814 +98 21 4483 3279 Dr.md.mohammadi@gmail.com Shahid Beheshti University of Medical Sciences scientific Ali Goljanian Tabrizi
ENT Department., Taleghani Hospital., Next to Shahid Beheshti University of Medical Sciences., Shahid Arabi St., Yemen St., Shahid Chamran Highway
Tehran Iran (Islamic Republic of) 1985711151 +98 21 2303 1111 ali.goljanian@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Age between 15 and 50 years Having chronic sinusitis with polyps Anosmia lasts less than 2 years Existence of anosmia confirmed by olfactory diagnosis test 15 years 50 years Both Suffering from systemic diseases such as diabetes mellitus, Parkinson's and Alzheimer's smoking Head injury history Previous surgical history of paranasal sinuses Congenital anosmia J33 R43.0 Nasal polyp Anosmia Treatment - Other Treatment - Surgery Intervention group: Patients in both groups underwent sinus endoscopic surgery by only one specific ENT specialist. At this stage, in the intervention group, a platelet-rich plasma was injected into the patient's nose inside the operating room and during general anesthesia. To do this, platelet-rich plasma was injected with a 1 cc syringe in the olfactory area within 1 cm2 with the help of a nasal endoscope and by the same surgeon from specific ENT specialists. The whole process of preparing platelet-rich plasma was performed in the sports medicine group under the supervision of the sports medicine professor and using Arjangian platelet-rich plasma kits. The temperature during these steps to prevent plaque clots was 21-24. C. Control group:After Functional endoscopic sinus surgery, in the control group, instead of platelet-rich plasma, normal saline serum was injected into the patient's olfactory area with the same amount and under the same conditions. The injector was also unaware of the group of patients and the injected substance. Olfactory score less than 6 in the Iranian Smell Identification Test. Timepoint: Measurement of olfactory score at the beginning of the study (before the intervention), After receiving oral treatment and 3 months after surgery and injection of platelet-rich plasma. Method of measurement: Iranian Smell Identification Test. Shahid Beheshti University of Medical Sciences Approved 2019-04-23 Iran National committee for Ethics in Biomedical Research floor 2., No. 11, Mohammadi Rd., East Kourosh St., North Janat Abad Blvd Tehran Tehran Iran (Islamic Republic of)