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IRCT20211109053018N1 IRCT 2022-09-10 صندوق نوآوری و شکوفایی Olfactory rehabilitation by Olfactrain product Evaluation of the effect and factors related to olfactory rehabilitation in patients with olfactory dysfunction afterCOVID-19 infection 2023-01-10 anticipated 240 Complete https://irct.ir/trial/63734 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The randomization type is blocked randomization. Bloke size 4 of intervention (A) and control (B) groups defined as (AABB, ABAB, ABBA, BBAA, BABA, BAAB) are written on six cards respectively on cards 1-6, then the cards in The envelope are placed. Each time, one of the cards is randomly taken out of the envelope and put together. Finally, a random string is made from the sequence of the selected cards (in the number of the sample size), respectively, patients A and B are entered into the study until the desired sample size is reached. 2-3 Loss of sense of smell, olfactory rehabilitation. Intervention 1: Patients are randomly divided into two intervention and control groups by using a quadruple block. Patients who are in the intervention group are treated for 3 months with olfactory training with the four main scents of rose, eucalyptus, clove, and lemon. After three months after the beginning of the study, the SIT test and the quality of life are done again and the results are compared with each other. Intervention 2: Control group: Patients in the control group are followed up for three months and after three months they are expected to have olfactory rehabilitation. 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 Its release schedule is not yet known
public Seyyed Behnam Abdollahi Boraei
No. 146, South Gandhi St., Vanak Sq., Tehran, Iran
Tehran Iran (Islamic Republic of) 1517964311 +98 21 6640 4050 behnam.abdollahi87@gmail.com Iranian academic center for education culture and research scientific Seyyed Behnam Abdollahi Boraei
No.146, South Gandhi St., Vanak Sq., Tehran, Iran
Tehran Iran (Islamic Republic of) 1517964311 +98 21 6640 4050 behnam.abdollahi87@gmail.com Iranian academic center for education culture and research Iran (Islamic Republic of) Decreased olfactory (anosmia and hyposmia) or olfactory change (phantom or crocosmia) after Covid 19 infection (infection detection method is recorded in the data entry form) At least 3 months have passed since the onset of olfactory disorder. 18 years 60 years Both History of head trauma or olfactory loss before Covid-19 infection History of surgery or brain tumor Patient examination or CT scan in patients is beneficial for olfactory conduction disorder History of similar treatments with olfactory training Neurodegenerative diseases that cause olfactory disorders such as Parkinson's and Levy Buddy disease R43.0 Anosmia Treatment - Drugs Diagnosis Patients are randomly divided into two intervention and control groups by using a quadruple block. Patients who are in the intervention group are treated for 3 months with olfactory training with the four main scents of rose, eucalyptus, clove, and lemon. After three months after the beginning of the study, the SIT test and the quality of life are done again and the results are compared with each other. Control group: Patients in the control group are followed up for three months and after three months they are expected to have olfactory rehabilitation Smell test score. Timepoint: Measure the olfactory test at the beginning of the study and 90 days after. Method of measurement: Test of 24 Iranian olfactory test. صندوق نوآوری و شکوفایی Approved 2022-02-28 کمیته اخلاق در پژوهش‌های زیست پزشکی بیمارستان امیر اعلم North Saadi Street Tehran Tehran Iran (Islamic Republic of)