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IRCT201611306699N3 IRCT 2017-01-05 Vice Chancellor for Research, Isfahan University of Medical Sciences Effectiveness of intra tympanic injection of the mixture of Dexamethason+hyaluronic acid in the treatment of sudden hearing loss. Therapeutic effect of intra tympanic injection of Dexamethasone-Hyaluronic acid combination in comparison with intra tympanic Dexamethasone in sudden sensorineural hearing loss 2016-02-20 anticipated 40 Complete https://irct.ir/trial/7112 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. N/A Condition 1: Hearing loss. Condition 2: Sudden hearing loss. Intervention 1: In intervention group, patients receive three intratympanic injections of 2 mg hyaluronic acid +2.4 mg Dexamethasone in combination. Intervention 2: The control group, receive three injections of 2.4 mg Dexamethasone intratympanically.
public Dr. Amin Kalcoo
Kashani Medical Center,
Isfahan, Iran (Islamic Republic of) +98 31 3233 0098 Amin_dr_60@yahoo.com Faculty of Medicin scientific Dr.Mehrdad Rogha
Kashani Medical Center,
Isfahan, Iran (Islamic Republic of) +98 31 3233 0098 rogha@med.mui.ac.ir Isfahan University of Medical Sciences Iran (Islamic Republic of) The inclusion criteria consisted of unilateral hearing loss (occurring within 72 hours), the hearing threshold average greater than 50 dB, symptoms appearance within 7 days from our intervention, patient's pure tone audiogram at frequencies 250 500, 1000, 2000, 4000 and 8000 Hz, age range 18-80 years, lack of acoustic tumor, middle ear diseases, autoimmune diseases, vestibular problem (Menier disease&..), cardiovascular disorders and diabetes, no history of ear surgery and the patient’s consent to participate in the study. Meanwhile patient’s refusal to attend on time for follow up visits, any limitation to inject intra tympanum via external auditory canal such as stenosis, anatomical deformities and external and middle ear infections were considered as exclusion criteria. 18 years 80 years Both H91.2 H91.2 Sudden idiopathic hearing loss Sudden idiopathic hearing loss Treatment - Drugs Treatment - Drugs In intervention group, patients receive three intratympanic injections of 2 mg hyaluronic acid +2.4 mg Dexamethasone in combination. The control group, receive three injections of 2.4 mg Dexamethasone intratympanically. Hearing threshold in different frequencies. Timepoint: Before & two weeks after intervention. Method of measurement: Pure tone audiometry. Infection. Timepoint: One week after intervention. Method of measurement: Ear examination. Vice Chancellor for Research, Isfahan University of Medical Sciences Approved 2015-12-29 Ethics Committee of Isfahan University of Medical Sciences Hezar Jerib st, Isfahan, Iran (Islamic Republic of)