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IRCT20181022041407N8 IRCT 2024-08-14 Mashhad University of Medical Sciences The effect of trehalose on Fatigue in MS Investigation of the effect of trehalose on Fatigue in patients with Multiple Sclerosis (MS) 2024-09-22 anticipated 60 Complete https://irct.ir/trial/78294 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block randomization will be done using the block sizes of 2 and 4 with randomization websites such as sealedenvelope.com. After randomization, the type of treatment will be written with odds and even numbers (or A/B codes) in separate papers and placed in an opaque envelope or the paper will be wrapped so that no one can see inside the paper (allocation concealment). After obtaining informed consent from the participants, one paper will be taken in order and according to the noted code, the participants will be placed in one of the intervention or placebo groups, Blinding description: ŮŽAfter randomization, the patients will be placed in two groups of A/B (or odds/even codes) and will received the products similar in shape and color (blinding of participants). The physician who will give the products to participants, received the boxes of the products with randomized codes (so the physician is blind too). The information of the patients and theirs treatment groups will be written with randomized codes (A/B) (the blinding of the assessor). Data will be entered to the SPSS software with codes (the blinding of the analyzer). N/A Multiple sclerosis. Intervention 1: Intervention group: Trehalose 10 g per day for 12 weeks, made by Shaanxi Fruiterco Biotechnology Co.,Ltd. Intervention 2: Control group: Placebo (one sachet of sucrose per day for 12 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 This project conducts between medical faculty and school of pharmacy and it is an interdisciplinary project. All of the collaborators must be satisfied with this item. We will decide about this part in future.
public Maryam Emadzadeh
Clinical Research Development Unit, Ghaem Hospital, Ahmadabad Blvd.
Mashhad Iran (Islamic Republic of) 9176699199 +98 51 3841 7403 maryamemadzadeh@yahoo.com Mashhad University of Medical Sciences scientific Amihossein Sahebkar
School of Pharmacy, University Campus, Azadi Square
Mashhad Iran (Islamic Republic of) 9177948954 +98 51 3180 1100 sahebkara@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Suffering from multiple sclerosis (MS) At least 6 months under treatment Age more than 18 Suffering from fatigue EDSS less or equal to 6 Satisfaction for participation in the research project Ability to read 18 years no limit Both Under treatment for depression G35 Multiple sclerosis Treatment - Drugs Placebo Intervention group: Trehalose 10 g per day for 12 weeks, made by Shaanxi Fruiterco Biotechnology Co.,Ltd. Control group: Placebo (one sachet of sucrose per day for 12 weeks) Fatigue score. Timepoint: At baseline and after 12 weeks. Method of measurement: Using Modified Fatigue Impact Scale (MFIS). Quality of life. Timepoint: At baseline and after 12 weeks. Method of measurement: Using European Quality of Life 5 Dimensions 3 Level Version (EQ-5D-3L). Depression and anxiety. Timepoint: At baseline and after 12 weeks. Method of measurement: Using Hospital Anxiety and Depression Scale (HADS). Ability to walk. Timepoint: At baseline and after 12 weeks. Method of measurement: Multiple Sclerosis Walking Scale-12 (MSWS-12). Mashhad University of Medical Sciences Approved 2024-06-22 Research Ethics Committees of Mashhad University of Medical Sciences Ghoreshi Building, Daneshgah Street Mashhad Razavi Khorasan Iran (Islamic Republic of)