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IRCT20171004036554N4 IRCT 2021-12-18 Tehran University of Medical Sciences Comparison of the therapeutic effects of intratympanic injections of Triamcinolon and Dexametasone who suffer from sudden sensorineural hearing loss Comparison of the therapeutic effects of intratympanic injections of Triamcinolon and Dexametason who suffer from sudden sensorineural hearing loss 2022-01-05 anticipated 62 Complete https://irct.ir/trial/60470 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: we use block randomization. we have blocks of four intervention (A) and four of control (B) groups and write them from 1-6 on cards and put them in a pocket, then choose them by chance and make a sequence of cards. We import patients of interventional or control group of our study from these sequences, Blinding description: The patient's consent states that the injection is done randomly with one of these drugs and the patient is unaware of the contents of the drug syringe. Also, the person who evaluates the patients' audiometry after the injection is unaware of which group the patient belongs to. 3 Sudden sensorineural hearing loss. Intervention 1: Intervention group: In the intervention group, using Triamcinolone ampoule 0.4-0.6 cc for Intratympanic injection that performed 6 injections twice aweek. Intervention 2: Control group: In the intervention group, using Dexamethasone 0.4-0.6 cc for Intratympanic injection that performed 6 injections twice aweek. 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 more information
public Saleh Habibi
South Chamran highway, Bagherkhan Blv, Imam Khomeini hospital complex
Tehran Iran (Islamic Republic of) 141765371 0098 21 61190 s.habibi@Gmail.com Tehran University of Medical Sciences scientific Hamed Emami
South Chamran highway, Bagherkhan Blv, Imam Khomeini hospital complex
Tehran Iran (Islamic Republic of) 141765371 0098 21 61190 hd_emami@yahoo.com Tehran University of Medical Sciences Iran (Islamic Republic of) All patients with SSNH diagnosis who are candidates for intratympanic injection Patients who have a contraindication to receive systemic corticosteroids, such as underlying diseases like diabetes or defective immune disorders . Patients who are interested in receiving intra tympanic corticosteroids instead of systemic corticosteroids . no limit no limit Both Patients who are candidates for receive systemic corticosteroids Patients who are not volunteer to receive intratympanic corticosteroids H91.23 Sudden idiopathic hearing loss, bilateral Treatment - Drugs Treatment - Drugs Intervention group: In the intervention group, using Triamcinolone ampoule 0.4-0.6 cc for Intratympanic injection that performed 6 injections twice aweek. Control group: In the intervention group, using Dexamethasone 0.4-0.6 cc for Intratympanic injection that performed 6 injections twice aweek. Hearing improvement based on audiometry. Timepoint: Complete response to treatment refers to an increase of 30 dB after 15 to 45 days after IT injection of dexamethasone and triamcinolone. The relative response to treatment refers to an increase of 10 dB 15 to 45 days after IT injection of dexamethasone. An improvement of less than 10 decibels will be considered as no response or failure of treatment. Method of measurement: Based on audiometry. Tehran University of Medical Sciences Approved 2021-11-29 Ethic committee of Amiralam Hospital Saadi Avenue, Enghelab Street Tehran Tehran Iran (Islamic Republic of)