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IRCT20200525047566N1 IRCT 2021-08-08 Shahid Beheshti University of Medical Sciences The effect of gabapentin on Dysgeusia after ear surgery Prevalence of Dysgeusia After Surgical Treatment of Chronic Otitis Media and Evaluation of Therapeutic Effect of Gabapentin 2020-08-21 anticipated 171 Complete https://irct.ir/trial/55624 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, we will use the balanced block randomization method. Blocking is used in order to balance the number of samples assigned to each group. The size of all the blocks is equal and we will have 10 blocks of 6 cases (including 3 participants in an intervention group and 3 participants in the control group) in this trial. Software allocation Random is used for randomization. This software capable to generate random sequences by block generation method. For hiding we use concealment allocation in a way that before the individual is assigned, the assigned group is not specified. In this method, each of the random sequences created on a cards are placed in the closed envelopes. In order to maintain a random sequence, the envelopes are numbered in the same way on the outer surface. Finally, the lids of the envelopes are glued and placed inside a box, respectively. At the time of registration of participants, based on the order of entry of the eligible participants in the study, one of the closed envelopes will be opened and the assigned group of the participant will be revealed, Blinding description: To reduce bias or bias related to the intervention and evaluation of the consequences, the method of double blind is used. In this method, the trial is planned in such a way that the participants do not know which of the two control or intervention groups he/she belongs to. Random blocks are also prepared by a person who is not involved in the treatment and are given to the therapist without informing the therapist. 3 Dysgeusia. Intervention 1: Intervention group: Patients with disgusia receive a daily dose of 600 mg of gabapentin capsules (Razak Pharmaceutical Company) for 3 months. Intervention 2: Control group: Patients with disgusia will also take a placebo from Razak (which is very similar to gabapentin) for 3 months. Yes - There is a plan to make this available What will be shared: All data is potentially shareable after unidentified individuals When: 3 months after printing the results To whom: Researchers working in academic institutions Conditions: To review similar studies Where to obtain: Send your request to the researcher's email to receive the data arash.esmaeili@gmail.com How to obtain: Data will be sent within 4 weeks after receiving the reques Comments:
public Arash Esmaeili
Ashrafi esfahani Boulevard, nastaran st, Dastgheib st, madani gharbi Alley, number 7
Tehran Iran (Islamic Republic of) 1476712345 +98 21 4422 3777 arash.esmaeili@gmail.com Shahid Beheshti University of Medical Sciences scientific Arash Esmaeili
Ashrafi esfahani Boulevard, nastaran st, Dastgheib st, madani gharbi Alley, number 7
Tehran Iran (Islamic Republic of) 1476712345 +98 21 4422 3777 arash.esmaeili@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) All patients who have undergone surgery to treat a chronic otitis media are questioned for the complication of Dysgeusia. 15 years no limit Both history of systemic diseases central and peripheral neurological diseases psychiatric illness metabolic disease history of Dysgeusia R43.8 Other disturbances of smell and taste Treatment - Drugs Treatment - Drugs Intervention group: Patients with disgusia receive a daily dose of 600 mg of gabapentin capsules (Razak Pharmaceutical Company) for 3 months. Control group: Patients with disgusia will also take a placebo from Razak (which is very similar to gabapentin) for 3 months. The amount of taste. Timepoint: After surgery and 3 months after treatment. Method of measurement: questionnaire. Shahid Beheshti University of Medical Sciences Approved 2021-02-15 Ethics Committee of Shahid Beheshti University No.15 ,3rd Allayi alley ,North Iranzamin St, Ponak Tehran Tehran Iran (Islamic Republic of)