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IRCT20110603006699N5 IRCT 2021-03-09 Esfahan University of Medical Sciences The effect of rivaroxaban on hearing loss Comparison and evaluation of the effect of rivaroxaban in the complementary treatment of sudden sensorineural hearing loss 2021-03-10 anticipated 34 Complete https://irct.ir/trial/54617 interventional Randomization: Not randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Blinding description: In this study, patients and researchers are unaware of the type of drug or placebo used, and the drugs are coded with the same shape and packaging. 2-3 Decreased sensorineural hearing. Intervention 1: Intervention group: Rivaroxaban 10 mg tablets of the َArena company are received daily for 10 days. Intervention 2: Control group: Placebo tablets with the same shape and color are taken daily for 10 days. Placebo has been prepared in the laboratory of the Faculty of Pharmacy, University of Isfahan. 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 Lack of coordination with relevant units in the university, college and hospital
public Ehsan moshtaghi
Esfahan University of Medical Science , Hezar Jerib street , Isfahan , Iran
Esfahan Iran (Islamic Republic of) 8174673461 0098312330066 ehsan_moshtaghi1989@yahoo.com Esfahan University of Medical Sciences scientific Mehrdad Rogha
Hezar jarib street, Isfahan
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3664 0352 rogha@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Diagnosis of SNHL by an ENT specialist Reduction of more than 30 dB in hearing at least 3 frequencies Body mass index between 18-30 kg per square meter Negative pregnancy test in women of reproductive age 15-35 years Normal coagulation tests Normal renal function Regular visits for follow up Consent to enter the study 18 years no limit Both Previous hemorrhagic diseases such as intracranial hemorrhage Previous coagulation diseases History of previous thrombosis anywhere on the body Active stomach ulcers History of psychiatric diseases Any previous illness or surgery on the ears Any signs of inflammation or infection of the ear on examination History of hearing loss Meniere's disease Recent vocal or compressive trauma Underlying disease that may be the cause of SNHL, such as trauma, autotoxic drugs, infection, etc Blood pressure higher than 180/110 Uncontrolled diabetes Hypersensitivity reaction to corticosteroids Taking drugs such as methadone H90.5 Unspecified sensorineural hearing loss Treatment - Drugs Placebo Intervention group: Rivaroxaban 10 mg tablets of the َArena company are received daily for 10 days. Control group: Placebo tablets with the same shape and color are taken daily for 10 days. Placebo has been prepared in the laboratory of the Faculty of Pharmacy, University of Isfahan. Pure tone audiometry Level. Timepoint: Beginning and end of the study. Method of measurement: Audiometric device. Word recognition score level. Timepoint: Beginning and end of the study. Method of measurement: Audiometric device. Esfahan University of Medical Sciences Approved 2020-10-17 Ethics committee of Isfahan university of medical science hezar jirib Ave, Isfahan university of medical science Isfahan Isfehan Iran (Islamic Republic of)