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IRCT20120215009014N339 IRCT 2020-02-07 Hamedan University of Medical Sciences Effect of co-enzyme Q10 versus placebo on treatment of tinnitus due to presbycusis Effect of co-enzyme Q10 versus placebo on treatment of tinnitus due to presbycusis: a triple-blind randomized clinical trial 2019-09-23 anticipated 50 Complete https://irct.ir/trial/45558 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random assignment of the patients to the intervention and control groups through the drawing of lots. To do this, we prepare two sheets and write "intervention" on one sheet and "control" on another. Then, by referring each patient, one of the sheets will be randomly taken and the patient will be assigned to the intervention or, Blinding description: The drugs will be given in coded envelopes. The shape of the medications and placebos will be perfectly the same. Therefore, patients will be unaware of the type of intervention. The physician who will examine the patients will not be aware of the intervention. The analyzer will be unaware of the type of interventions Thus, the trial will be run as triple-blind. 2 Tinnitus. Intervention 1: Intervention group: Neurotriptyline tablet 25 mg (manufactured by Darupakhsh Pharmaceutical Co.) daily plus co-enzyme Q10 tablet 100 mg (manufactured by Health Aid Co.) daily for 6 weeks. Intervention 2: Control group: Neurotriptyline tablet 25 mg (manufactured by Darupakhsh Pharmaceutical Co.) daily plus placebo tablet 100 mg daily for 6 weeks. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is It depends on the situations and the results of the study as well as the approval of the financial supporting organization.
public Dr Zahra Sadeghi
School of Medicine, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
Hamadan Iran (Islamic Republic of) 6517838695 +98 81 3838 0572 sazcsaz66@gmail.com Hamedan University of Medical Sciences scientific Dr. Rooholah Abbasi
School of Medicine, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
Hamadan Iran (Islamic Republic of) 6517838695 +98 81 3838 0572 Ruholah@abasihatmil.com Hamedan University of Medical Sciences Iran (Islamic Republic of) Age of 50 to 90 years, Tinnitus for over a year, Bilateral neural sensorineural hearing loss 50 years 90 years Both Psychosomatic disorder, Consumption of calcium, vitamin and magnesium in the past two months, Tinnitus due to drug side effects, Atypical tinnitus, Meniere's disease, Conductive hearing loss H93.1 Tinnitus Treatment - Drugs Placebo Intervention group: Neurotriptyline tablet 25 mg (manufactured by Darupakhsh Pharmaceutical Co.) daily plus co-enzyme Q10 tablet 100 mg (manufactured by Health Aid Co.) daily for 6 weeks Control group: Neurotriptyline tablet 25 mg (manufactured by Darupakhsh Pharmaceutical Co.) daily plus placebo tablet 100 mg daily for 6 weeks Severity of tinnitus. Timepoint: Before the intervention and 6 months later. Method of measurement: Using the Tinnitus Handicap Inventory (THI). Sleep disorder. Timepoint: Before the intervention and 6 months later. Method of measurement: Using the Petersburg questionnaire. Quality of life. Timepoint: Before the intervention and 6 months later. Method of measurement: Using the SF-36 questionnaire. Hamedan University of Medical Sciences Approved 2019-07-06 Ethics Committee of Hamadan University of Medical Sciences Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave Hamadan Hamadan Iran (Islamic Republic of)