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IRCT20190427043389N4 IRCT 2023-08-11 Zanjan University of Medical Sciences The effectiveness of the combination of Memantine and Betahistine on insomnia severity, quality of life and severity of symptoms in people with primary tinnitus The effectiveness of the combination of Memantine and Betahistine on insomnia severity, quality of life and severity of symptoms in people with primary tinnitus 2023-08-27 anticipated 60 Complete https://irct.ir/trial/71649 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Eligible people will be selected from the usual referrals to the neurology clinic of Vali Asr Zanjan educational center by the available method and then will be allocated to two groups by random block method (blocks of 4). The first group will receive Betahistine plus Memantine and the second group will receive Betahistine plus placebo. For this purpose, blocks of 4 will be selected using a table of random numbers in the size of 15 blocks so that the sample size reaches 60 people. Blocking will be done by a person not involved in sampling. Each of the generated random sequences will be recorded on a card and the cards will be placed in the envelopes in order. Finally, the lids of the envelopes will be glued and placed inside a box. At the start of the intervention to identify the order of the participants, one of the envelopes will be opened in order and the assigned group of that participant will be revealed, Blinding description: In this study, people will be assigned to two groups by random block method (blocks of 4). Patients will be blinded in this study. One group will receive Betahistine tablets along with Memantine tablets, while the other group will receive Betahistine tablets along with a placebo. Placebo tablets are very similar to Memantine tablets in terms of color, shape and size, but do not contain the active drug. Both pills are manufactured by the same pharmaceutical company. 3 Condition 1: Severity of tinnitus symptoms. Condition 2: Insomnia severity. Condition 3: Quality of Life. Intervention 1: Intervention group: 8 mg of Betahistine tablets plus Memantine tablets with instructions to take from the first to the seventh day: 5 mg; 8th to 14th day: 5 mg twice a day; 15th to 21st day: 5 mg in the morning and 10 mg in the evening; From the 22nd day to the 90th day, 10 mg twice a day. Intervention 2: 8 mg Betahistine tablets and placebo. Yes - There is a plan to make this available What will be shared: Part of the data, such as the information related to the main outcome, can be shared. When: three months To whom: researchers Conditions: A person can access the data after requesting the person in charge of the trial and checking her reliability. Where to obtain: Central Library of Zanjan University of Medical Sciences How to obtain: A person can access the data after requesting the person in charge of the trial and checking her reliability. Comments:
public Dr. Hamed Ghavimi
Gavazang Road - next to Ayatollah Hospital. Mousavi - Faculty of Pharmacy, Zanjan
Zanjan Iran (Islamic Republic of) 4513956184 +98 24 3347 3635 Hamed.ghavimi@gmail.com Zanjan University of Medical Sciences scientific Dr. Hamed Ghavimi
Gavazang Road - next to Ayatollah Hospital. Mousavi - Faculty of Pharmacy, Zanjan
Zanjan Iran (Islamic Republic of) 4513956184 +98 24 3347 3635 Hamed.ghavimi@gmail.com Zanjan University of Medical Sciences Iran (Islamic Republic of) Having primary tinnitus for more than 3 months Willingness and interest to participate in the study Having moderate intensity of insomnia (scoring more than 15 based on the ISI Insomnia Severity Questionnaire) 18 years 60 years Both Tinnitus due to anatomical disease tumor Previous use of memantine History of high blood pressure Suffering from chronic and debilitating diseases as diagnosed by the attending physician Known mental illness Concomitant use of medications that interact with memantine contraindication of memantine by the doctors diagnosis H93.1 G47.0 Tinnitus Insomnia Treatment - Drugs Placebo Intervention group: 8 mg of Betahistine tablets plus Memantine tablets with instructions to take from the first to the seventh day: 5 mg; 8th to 14th day: 5 mg twice a day; 15th to 21st day: 5 mg in the morning and 10 mg in the evening; From the 22nd day to the 90th day, 10 mg twice a day. 8 mg Betahistine tablets and placebo Severity of tinnitus intensity. Timepoint: Before intervention and 3 months after the start of the intervention. Method of measurement: Tinnitus severity index standard questionnaire. Insomnia severity. Timepoint: Before the start of the intervention and 3 months after the start of the intervention. Method of measurement: ISI Insomnia Severity Index Questionnaire. Quality of Life. Timepoint: Before the start of the intervention and 3 months after the start of the intervention. Method of measurement: Standard Quality of Life Questionnaire (SF-36). Zanjan University of Medical Sciences Approved 2023-07-18 Rsearch Ethics Committee of Zanjan University of Medical Sciences Jomhouri Street, Azadi Boulevard, University Headquarters, 1st floor, Deputy of Research and Technology, Zanjan University of Medical Sciences Zanjan Zanjan Iran (Islamic Republic of)