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IRCT20200430047245N1 IRCT 2021-05-23 Shahid Beheshti University of Medical Sciences The study of effectiveness of systemic Magnesium in treatment of sudden sensory neural hearing loss versus placebo The study of effectiveness of systemic Magnesium in treatment of sudden sensory neural hearing loss versus placebo in patient referred to ear nose and throat clinic of Taleqani hospital. 2021-04-24 anticipated 64 Complete https://irct.ir/trial/48326 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Blocked randomization. According to the number of 64 samples in the randomization method, 8 blocks with 8 parts with the identifiers A, B, C, D, E, F, G, H are created, which We put in 4 of them drugs and the other 4 placebos with complete physical characteristics. The blocks are placed in the clinic after made them.And participants in the project are given a part of a block and patient information and number and part of the block will be recorded, Blinding description: Double blind study. Due to the blocked randomization method, the participant and the researcher are blinded to the content of each block component.And participants do not know the content of the received block. And the researcher only records the patient information and the number and part of the delivered block and remains blind to the contents of the block throughout the treatment and study course. 3 Sudden sensory nueral hearing loss. Intervention 1: Intervention group: In this group, patients with sensorineural hearing loss undergo standard treatment with oral corticosteroids at a dose of 1 mg per kg body weight per day with 50 mg tablets of Iran hormon company and 250 mg magnesium oxide by Galinus company daily for 14 days. The treatment process is assesed by audiometry in Taleghani Hospital audiometry center, before the start of treatment and at the end of the 14th day of treatment and the end of 1 month. Intervention 2: Control group: In this group, patients are treated with standard treatment with prednisolone with 50 mg tablets of Iran Hormone Company at a dose of 1 mg per kg body weight and microcrystalline cellulose placebo one tablet per day with a completely similar appearance to the main drug for 14 days .And the treatment process is assesd by performing audiometry in the audiometry center of Taleghani Hospital at the beginning of treatment and on the 14th day of treatment and at the end of 1 month. Yes - There is a plan to make this available What will be shared: Patient audiometric files will be provided at the end of the project When: Access period starts 3 months after the results are published To whom: The data will be available to scientific researchers Conditions: Data are available for further studies on sudden sensorineural hearing loss and magnesium effects Where to obtain: To receive the data, correspond with the email of the project manager (Mohammad Taha Mehdi Araghi Email: Tahamehdiaraghi1990@gmaile.com How to obtain: After receiving the request for access to information from qualified people, the data will be sent within 1 week. Comments:
public Mohammad Taha Mehdi Araghi
Taleghani hospital, next to Shahid Beheshti University of Medical Sciences, Shahid Arabi St., Yemen St., Shahid Chamran Highway
Tehran Iran (Islamic Republic of) 1469964383 +98 21 2303 1111 tahamehdiaraghi1990@gmail.com Shahid Beheshti University of Medical Sciences scientific Mohammad Taha Mehdi Araghi
Taleghani hospital, next to Shahid Beheshti University of Medical Sciences, Shahid Arabi St., Yemen St., Shahid Chamran Highway
Tehran Iran (Islamic Republic of) 1469964383 +98 21 2303 1111 tahamehdiaraghi1990@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Affection to sudden sensory neural hearing loss The reason of sudden sensory neural hearing loss be idiopathic 18 years no limit Both Referral after 1 month from the onset of the disease Contraindications to oral corticosteroids such as diabetes, hypertension, gastric ulcer or duodenum Evidence of systemic infectious or inflammatory diseases Coagulation disorders Other known causes of sudden sensory neural hearing loss H91.2 Sudden idiopathic hearing loss Treatment - Drugs Treatment - Drugs Intervention group: In this group, patients with sensorineural hearing loss undergo standard treatment with oral corticosteroids at a dose of 1 mg per kg body weight per day with 50 mg tablets of Iran hormon company and 250 mg magnesium oxide by Galinus company daily for 14 days. The treatment process is assesed by audiometry in Taleghani Hospital audiometry center, before the start of treatment and at the end of the 14th day of treatment and the end of 1 month. Control group: In this group, patients are treated with standard treatment with prednisolone with 50 mg tablets of Iran Hormone Company at a dose of 1 mg per kg body weight and microcrystalline cellulose placebo one tablet per day with a completely similar appearance to the main drug for 14 days .And the treatment process is assesd by performing audiometry in the audiometry center of Taleghani Hospital at the beginning of treatment and on the 14th day of treatment and at the end of 1 month Average hearing threshold. Timepoint: Mean hearing threshold before the start of the study and 14 days after the intervention and the end of the month. Method of measurement: Audiometry. Personal cost of the project executor Approved 2021-02-15 Ethics Committee of Shahid Beheshti University of Medical Sciences Research Ethics Committee, School of Medicine, next to Ayatollah Taleghani Hospital, Shahid Arabi St., Yemen St., Shahid Chamran Highway Tehran Tehran Iran (Islamic Republic of)