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IRCT20211010052721N2 IRCT 2022-06-27 Mashhad University of Medical Sciences The effect of enoxaparin on sudden sensorineural deafness Evaluation the effectiveness of treatment with enoxaparin as adjunctive therapy in the treatment of patients with idiopathic retention sensorineural hearing loss 2022-07-21 anticipated 60 Complete https://irct.ir/trial/64364 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomization with table of random numbers available at ''www.randomization.com'' website will be used. Numbers will be placed in sealed envelopes and each envelope is assigned to one participant placing them in one of the two groups. 2-3 Sudden sensorineural hearing loss. Intervention 1: Intervention group: In the intervention group, oral prednisolone (1 mg / kg) for 10 days and dexamethasone in the ear (5 mg / ml) for a total of 10 times daily plus, 1 mg / kg subcutaneously enoxaparin (enoxaparin sodium ampoule) 6000 units) will be injected twice a day for 10 days. Intervention 2: Control group: In this group, oral prednisolone (1 mg / kg) will be administered for 10 days and dexamethasone in the ear at a dose (5 mg / ml) will be given daily and a total of 10 times. Also, aspirin 80 mg daily will be prescribed. 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 After finishing work, consult with colleagues and it will be published if all members
public Navid Nourizadeh
Ghaem Hospital, Ahmad Abad AVE
Mashhad Iran (Islamic Republic of) 99199-91766 +98 51 3841 3492 nourizadehn@mums.ac.ir Mashhad University of Medical Sciences scientific Navid Nourizadeh
خیابان احمدآباد، بیمارستان قائم
Mashhad Iran (Islamic Republic of) 99199-91766 +98 51 3841 3492 nourizadehn@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Conscious consent to participate in the study Patients with sudden sensorineural hearing loss that progresses rapidly and no known cause is found for more than 72 hours 18 years no limit Both History of ear diseases Patients with contraindications to treatment with systemic corticosteroids or anticoagulants such as diabetes mellitus History of intermittent hearing loss Pregnancy Breastfeeding H90.3 Sensorineural hearing loss, bilateral Treatment - Drugs Treatment - Drugs Intervention group: In the intervention group, oral prednisolone (1 mg / kg) for 10 days and dexamethasone in the ear (5 mg / ml) for a total of 10 times daily plus, 1 mg / kg subcutaneously enoxaparin (enoxaparin sodium ampoule) 6000 units) will be injected twice a day for 10 days. Control group: In this group, oral prednisolone (1 mg / kg) will be administered for 10 days and dexamethasone in the ear at a dose (5 mg / ml) will be given daily and a total of 10 times. Also, aspirin 80 mg daily will be prescribed. Average hearing threshold. Timepoint: Before the intervention and 10 days after starting taking enoxaparin. Method of measurement: Audiometry. Mashhad University of Medical Sciences Approved 2022-05-10 کمیته اخلاق دانشگاه علوم پزشکی مشهد Central Building of Mashhad University of Medical Sciences (Ghoreishi), Daneshgah 16, Daneshgah Street Mashhad Razavi Khorasan Iran (Islamic Republic of)