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IRCT20190325043107N48 IRCT 2024-08-10 Tabriz University of Medical Sciences Investigating the effects and side effects of bupropion in multiple sclerosis patients Investigating the effect and side effects of bupropion on fatigue, disability and quality of life of multiple sclerosis patients 2024-10-21 anticipated 80 Complete https://irct.ir/trial/75848 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, with a sample size of 80, we use the patients using the block permutation randomization method, which is used in this method to balance the number of allocated samples, and with 4 people in each block. We assemble the possible blocks as follows. block 1: BBAA, block 2: AABB, block 3: ABAB, block 4: BABA, block 5: ABBA, and block 6: BAAB, we need 20 blocks for 80 people. It is random in the block method. We choose numbers from one to six. For example, if number 6 is chosen as the first block and number 2 as the second block, the people who enter the study will be given BAABAABB in order from left to right. and finally they will divid into two intervention groups (group A) and control group (group B), Blinding description: The thesis results analyst who will analyze the expected result and also the participants will be unaware of the type of procedure performed and will be blind during the study; Therefore, this study will be conducted in a double-blind manner. Since the participants will be unaware of the type of technique used, in this study they will not know what type of technique will be used in other patients. 2-3 Quality of life. Intervention 1: Intervention group: The patients of this group will be prescribed bupropion (150 mg/extended release product of Obidi company) once a day for six months in addition to routine treatments, and finally the quality of life (measured using the McGill Quality of Life Questionnaire) and fatigue. and disability (measurement in the form of physical examination and questions from the patient himself) will be measured once a month for six months. Intervention 2: Control group: Patients of this group will be prescribed placebo (the same color, shape and size of the intervention group pills) once a day for six months in addition to the routine treatments, and finally the quality of life (measured with the help of the McGill Quality of Life Questionnaire) ) and fatigue and disability (measured by physical examination and asking the patient himself) will be measured once a month for six months. 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 There is no further information.
public Rana Malek_Mohammadi
Imam Reza Hospital, Azadi Ave
Tabriz Iran (Islamic Republic of) 5165665631 +98 41 3335 7310 Mkhanbabayi@yahoo.com Tabriz University of Medical Sciences scientific Mehdi Khanbabayi Gol
Imam Reza Hospital, Azadi Ave
Tabriz Iran (Islamic Republic of) 5981764863 +98 41 3334 7054 Khanbabayimehdi69@gmail.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Definitive diagnosis of multiple sclerosis based on MacDonald criteria 2017 version EDSS value smaller than four 18 years 65 years Both Taking drugs that have a reducing or intensifying effect on fatigue, such as dalfampridine, modafinil, antidepressants and other psychiatric drugs. Using other auxiliary methods such as herbal medicines, antidepressants, yoga, unnecessary supplements, addiction or drug use G35 Multiple sclerosis Treatment - Drugs Treatment - Drugs Intervention group: The patients of this group will be prescribed bupropion (150 mg/extended release product of Obidi company) once a day for six months in addition to routine treatments, and finally the quality of life (measured using the McGill Quality of Life Questionnaire) and fatigue. and disability (measurement in the form of physical examination and questions from the patient himself) will be measured once a month for six months. Control group: Patients of this group will be prescribed placebo (the same color, shape and size of the intervention group pills) once a day for six months in addition to the routine treatments, and finally the quality of life (measured with the help of the McGill Quality of Life Questionnaire) ) and fatigue and disability (measured by physical examination and asking the patient himself) will be measured once a month for six months. Quality of life. Timepoint: Once every month for six months. Method of measurement: McGill Quality of Life Questionnaire. Fatigue. Timepoint: Once every month for six months. Method of measurement: Physical examination and asking the patient himself. Disability. Timepoint: Once every month for six months. Method of measurement: Physical examination and asking the patient himself. Tabriz University of Medical Sciences Approved 2024-07-21 Ethics committee of Tabriz University of Medical Sciences Imam Reza Hospital, Azadi Ave Tabriz East Azarbaijan Iran (Islamic Republic of)