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IRCT20160813029327N24 IRCT 2024-09-20 Islamic Azad University The effect of Selenium on Idiopathic Tinnitus Clinical trial of the effect of selenium in idiopathic tinnitus 2024-09-22 anticipated 60 Complete https://irct.ir/trial/77719 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random number table: 2 groups of 30 patients were created by 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 selenium 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 Selenium supplement in the form of 200 microgram tablet every day for two months - Selenium Health Burst - Porateb Company. 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 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: One year after printing the results and publishing the article 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
#99, the first 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) Having tinnitus that does not have specific pathological examinations. Having normal hearing or Suffering from degrees of mild to severe hearing loss in the frequency range of 250-8000 Hz 18 years 65 years Both Taking anticoagulant drugs Pregnancy or intention to become pregnant Not being in a good general mood Observing any unforeseen complications Lack of cooperation in psychoacoustic assessments of tinnitus Receiving concomitant medical treatment or other tinnitus rehabilitation History of Otological and Neurological Diseases Breastfeeding Presence of pulsating tinnitus H93.1 Tinnitus Treatment - Drugs Placebo Intervention group: For people who met the criteria for entering the research, they will receive a Selenium supplement in the form of 200 microgram tablet every day for two months - Selenium Health Burst - Porateb Company. Control group: In people who met the criteria for entering the research, they will receive a placebo in the form of oral tablets every day for two months. Tinnitus annoyance index. 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. Psychoacoustic assessments of tinnitus. Timepoint: At the beginning of the study (before the intervention) and 60 days after starting the treatment. Method of measurement: Determination of perceived loudness of tinnitus by the patient through LMT(Loudness Matching of Tinnitus), PMT(Pitch Matching of Tinnitus), MML(Minimal Masking Level). 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 2024-06-18 Ethics committee of Islamic Azad university of pharmaceutical sciences No. 99, Yakhchal Ave., Gholhak, Shariati St., Tehran Tehran Tehran Iran (Islamic Republic of)