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IRCT20200708048051N1 IRCT 2020-08-01 Rasht University of Medical Sciences Assessment of the effect of rivaroxaban on sudden sensorineural hearing loss Assessment of the effect of rivaroxaban as Adjuvant Treatment for improvement of Idiopathic Sudden Sensorineural Hearing Loss 2020-08-22 anticipated 140 Complete https://irct.ir/trial/49479 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: After receiving the explanations about the project, the mentioned patients are divided into two control group and intervention group by permuted block randomization. Blocking is usually used to balance in number of assigned samples to each one of studied groups. This feature helps researchers to in cases that mid-term analyzes are required during the sampling process, number of samples assigned to each of the study groups be equal,First, the software prepares a list of 4 blocks in which an equal number of people are randomly placed in two groups A and B. This list is placed in a separate envelope and then the envelope is closed and given to a third party. If the patient is referred to and qualified, one of the pocket is given to the patient, according to the number. After filling the forms, the pocket is opened and a patient is treated according to the desired number and receives the related intervention. Patients and researchers will not be informed of the type of received intervention, Blinding description: individuals under study, physicians caring for patients and those assessing outcomes and study researchers are kept blind to specific study groups. after selecting patients medications are given to patients in un named and similar envelopes by third person, and the list of patients in each group will not be disclosed until the end of data analysis. 3 Idiopathic Sudden Sensorineural Hearing Loss. Intervention 1: Intervention group: Prednisolone (Nisopred ®, Iranhormone Co.) tablets at a dose of 1 mg / kg daily (maximum 60 mg as a single dose in the morning) for 10 days and then taper for 5 days (10 mg daily decreases) and valaciclovir (Virabex ® , Abidi Co.) 500 mg every 8 hours (3 times a day) ) For 7 days and pantoprazole (Abidi Co.) 40 mg daily (for 15 days) and rivaroxaban (Xalerban ®, Abidi Co.) at a dose of 20 mg daily for 10 days. Intervention 2: Control group: Prednisolone (Nisopred ®, Iranhormone Co.) tablets at a dose of 1 mg / kg daily (maximum 60 mg as a single dose in the morning) for 10 days and then taper for 5 days (10 mg daily decreases) and valaciclovir (Virabex ® , Abidi Co.) 500 mg every 8 hours (3 times a day) ) For 7 days and pantoprazole (Abidi Co.) 40 mg daily (for 15 days) and placebo with the same form as rivaroxaban for 10 days. Yes - There is a plan to make this available What will be shared: after the end of the study period When: after the end of the study period To whom: After the end of the study period, the results will be available to the public in the form of articles Conditions: If published as an article Where to obtain: ENT Research Center of Guilan University of Medical Sciences How to obtain: In-person referral or electronic request to the ENT Research Center of Guilan University of Medical Sciences Comments:
public Dr. Mir Mohammad Jalali
Amiralamomenin Hospital, 17 Shahrivar St
Rasht Iran (Islamic Republic of) 41396-37459 +98 13 3322 5242 mmjalali@gmail.com Rasht University of Medical Sciences scientific Dr. Mir Mohammad Jalali
Amiralmomenin Hospital, 17 Shahrivar Ave, Emam Khomeini Ave
Rasht Iran (Islamic Republic of) 4139637459 +98 13 3323 8306 mmjalali@gmail.com Rasht University of Medical Sciences Iran (Islamic Republic of) Patients with a unilateral sudden sensory hearing loss Refer to the hospital in less than 5 days from the onset of symptoms Hearing loss of ≥ 30 dB at least 3 consecutive frequencies in the audiometery. 18 years 65 years Both Patients with a history of hearing loss, trauma to the ear, active ear infection, congenital cochlear disease Use of ototoxic drugs, anticoagulants, anticonvulsants. Cardiovascular disease, coagulation disorders, and diabetes. Retro cochlear lesions Severe renal and hepatic impairment (Cr clearance less than 15) People with neoplasms who have not been treated or are being treated with chemotherapy or radiotherapy. pregnancy and breastfeeding Patients with history of autoimmune disorder Patients with platelet count disorder (less than 150,000) H91.20 Sudden idiopathic hearing loss, unspecified ear Treatment - Drugs Placebo Intervention group: Prednisolone (Nisopred ®, Iranhormone Co.) tablets at a dose of 1 mg / kg daily (maximum 60 mg as a single dose in the morning) for 10 days and then taper for 5 days (10 mg daily decreases) and valaciclovir (Virabex ® , Abidi Co.) 500 mg every 8 hours (3 times a day) ) For 7 days and pantoprazole (Abidi Co.) 40 mg daily (for 15 days) and rivaroxaban (Xalerban ®, Abidi Co.) at a dose of 20 mg daily for 10 days Control group: Prednisolone (Nisopred ®, Iranhormone Co.) tablets at a dose of 1 mg / kg daily (maximum 60 mg as a single dose in the morning) for 10 days and then taper for 5 days (10 mg daily decreases) and valaciclovir (Virabex ® , Abidi Co.) 500 mg every 8 hours (3 times a day) ) For 7 days and pantoprazole (Abidi Co.) 40 mg daily (for 15 days) and placebo with the same form as rivaroxaban for 10 days Hearing threshold. Timepoint: Before starting treatment and 2 weeks after and 3 months after starting treatment. Method of measurement: Pure tone audiometry. Rasht University of Medical Sciences Approved 2020-07-01 Ethics committee of Guilan University of Medical Sciences Vice-chancellor for Research Building, opposite of Sepah Bank, Shahid Beheshti Blvd Rasht Guilan Iran (Islamic Republic of)