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IRCT20160813029327N26 IRCT 2024-10-04 Islamic Azad University The effect of magnesium in idiopathic tinnitus Clinical trial of the effect of magnesium compared to placebo in idiopathic tinnitus 2024-11-05 anticipated 60 Complete https://irct.ir/trial/77939 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random number table: two groups of 30 patients were created using a simple randomization method through the website www.random.org and based on the Random Sequence Generator. To hide the random allocation, the method of opaque sealed envelopes with a random sequence was used. Patients were divided into one of two groups receiving magnesium or receiving placebo based on the sequence of referrals, Blinding description: This study is a double-blind, placebo-controlled study; So that in this study, both the research subject and the therapist are unaware of the patient's medication. Medicines are delivered to the patient in uniform packages marked with a unique code by a third person, and the information about the type of medicine cannot be seen by the therapist. 3 tinnitus. Intervention 1: Intervention group:For people who met the criteria for entering the research, they will receive a magnesium tablet in the form of 250 mg tablet - jalinous every day for two months. Intervention 2: Control group:In people who met the criteria for entering the research, they will receive a placebo in the form of oral tablets made in Islamic Azad University , every day for two months. Yes - There is a plan to make this available What will be shared: Patients' Demographic Data,Scores obtained from tinnitus performance questionnaire and hearing threshold When: After publication of paper, for one year To whom: Academic persons Conditions: Users should refer to the article Where to obtain: By sending an email to the corresponding author How to obtain: By sending an email to the corresponding author Comments:
public Younes Lotfi
Rafideh specialized hospital , Shahid Nemati Alley, South Salimi Street, Andarzgoo Blvd., Qeytariyeh
Tehran Iran (Islamic Republic of) 1935973476 +98 21 2220 5326 yones1333@gmail.com Shahid Beheshti University of Medical Sciences scientific Ramin Abrishami
No. 99, at the beginning of Yakhchal Ave., Gholhak, Shariati St.
Tehran Iran (Islamic Republic of) 1941933111 021-226400515 r_abrishami@iaups.ac.ir Islamic Azad University Iran (Islamic Republic of) Iran (Islamic Republic of) Idiopathic tinnitus Patients over 18 years old and under 65 years old Informed consent 18 years 65 years Both Taking anticoagulant drugs Pregnancy or intention to become pregnant Not feeling well Observation of any unpredictable complications Non-cooperation in psychoacoustic assessments The presence of pulsating tinnitus History of otological and neurological disease Breastfeeding Vitamin D deficiency H93.1 Tinnitus Treatment - Drugs Placebo Intervention group:For people who met the criteria for entering the research, they will receive a magnesium tablet in the form of 250 mg tablet - jalinous every day for two months Control group:In people who met the criteria for entering the research, they will receive a placebo in the form of oral tablets made in Islamic Azad University , every day for two months. Tinnitus annoyance index and psychoacoustic assessments of tinnitus. Timepoint: At the beginning of the study (before the intervention) and 60 days after starting the treatment. Method of measurement: Tinnitus Handicap Inventory (THI) questionnaire and determination of perceived loudness of tinnitus by the patient through LMT, PMT, MML. Hearing threshold. Timepoint: At the beginning of the study (before the intervention) and 60 days after starting the treatment. Method of measurement: Audiogram chart or ear tape. Islamic Azad University Approved 2024-05-25 Ethics committee of Pharmaceutical Sciences Unit, Islamic Azad university No. 99, Yakhchal Ave., Gholhak, Shariati St., Tehran Tehran Tehran Iran (Islamic Republic of)