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IRCT20181022041407N14 IRCT 2025-06-19 Mashhad University of Medical Sciences The effect of intravenous trehalose on Fatigue in MS Investigating the effect of intravenous Trehalose on the fatigue and performance of a patient with Multiple Sclerosis 2025-09-23 anticipated 1 Complete https://irct.ir/trial/84329 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment. N/A Multiple Sclerosis. Intervention group: IV Trehalose (15 g per week) for 12 weeks by Dr.Rajabi Pharmaceutical Co.. 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 and pharmacy faculty 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) Diagnosis of multiple sclerosis (MS) Suffering from fatigue Satisfaction for participation in the research project Living in Mashhad 18 years no limit Both Willingness to withdraw from the study Exacerbation of manifestations of MS after each IV administration Under treatment for depression Multiple S G35 Treatment - Drugs Intervention group: IV Trehalose (15 g per week) for 12 weeks by Dr.Rajabi Pharmaceutical Co. 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). Inflammatory markers including C-reactive protein, gene expression of TNFα, IFNγ, IL10, IL16, IL17). Timepoint: At baseline and after 12 weeks. Method of measurement: Blood Sample. Mashhad University of Medical Sciences Approved 2025-04-26 Research Ethics Committees of Mashhad University of Medical Sciences Ghoreshi Building, Daneshgah Street Mashhad Razavi Khorasan Iran (Islamic Republic of)