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IRCT20240118060725N1 IRCT 2024-02-14 Qazvin University of Medical Sciences The effect of memantine on fatigue in patients with Multiple Sclerosis Comparison of effectiveness of memantine and vitamin B1 in fatigue of patients with multiple sclerosis​ 2024-03-20 anticipated 60 Complete https://irct.ir/trial/75085 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients are assigned to two treatment groups A and B using the method of random blocks(Balance block randomization), the size of each block is 10 and the total number of blocks is 5 as 10 and the total number of blocks is 5 as described in the attached table. The balanced in randomization allocation method for the participants in the randomized controlled clinical trial study is the effect of receiving memantine (group A)and placebo (group B)in reducing fatigue. Data will be analyzed in spss software version 23,using descriptive tests such as mean and standard deviation(for continious quantitative variables such as age)and number and percentage (for qualitative/nominal variables such as gender). The data are analyzed by independent test to check the relationship between quantitative variables between two chi-square to check the relationship between qualitative variables between two groups. A statistically significant level of 5%is considered, Blinding description: Patients are assigned to two treatment groups A and B using the method of random blocks (Balance block randomization). Balanced randomization allocation method for participants in a randomized controlled clinical trial study on the effect of receiving memantine (group A) and placebo (group B) in reducing fatigue. 3 Multiple Sclerosis. Intervention 1: intervention group:Memantine 5 mg tablets by Hacim company .First daily for a week,then one every 12 hours for 3 months and orally. This drug is a competitive NMDA glutamate antagonist. Intervention 2: Control group:Vitamin B1 100 mg tablets by Hacim company.First daily for a week , then one every 12 hours for 3 months and orally.This medicine is a water-soluble vitamin. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no customer information
public Fateme Jafari Chamandani
Bu Ali St ، Bu Ali Hospital
Qazvin Iran (Islamic Republic of) 3413786165 +98 28 3333 2930 fatemejafari78@gmail.com Qazvin University of Medical Sciences scientific Fateme Jafari Chamandani
Bu Ali St. Bu Ali Hospital
Qazvin Iran (Islamic Republic of) 3413786165 +98 28 3333 2930 fatemejafari78@gmail.com Qazvin University of Medical Sciences Iran (Islamic Republic of) Age 20-50 years EDSS between 0-5 Relapsing-Remitting MS Grade 3 or 4 fatigue according to the questionnaire​ 20 years 50 years Both Use of Modafinil, Ritalin or Amantadine History of seizures or kidney disease Taking selective serotonin reuptake inhibitor (SSRI) Recent attack within the last 3 months Use of Dalfira G35 Multiple sclerosis Treatment - Drugs Placebo intervention group:Memantine 5 mg tablets by Hacim company .First daily for a week,then one every 12 hours for 3 months and orally. This drug is a competitive NMDA glutamate antagonist. Control group:Vitamin B1 100 mg tablets by Hacim company.First daily for a week , then one every 12 hours for 3 months and orally.This medicine is a water-soluble vitamin Examining the degree of fatigue based on the Modified Fatigue Impact Scale questionnaire. Timepoint: Comparison of fatigue before and 3 months after starting memantine and placebo. Method of measurement: Modified Fatigue Impact Scale questionnaire. Qazvin University of Medical Sciences Approved 2023-12-26 Ethics committee of Qazvin University of Medical Sciences Bo Ali St. Bo Ali Sina Hospital Qazvin Qazvin Iran (Islamic Republic of)