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IRCT20180818040827N3 IRCT 2021-10-06 Esfahan University of Medical Sciences The effect of ginger consumption in patients with multiple sclerosis The effect of ginger consumption on serum levels of neurofilament light polypeptide, matrix metalloproteinase-9, interleukin-17, nitric oxide metabolites, and differential leukocyte count and score of disability status, quality of life, and gastrointestinal symptoms in patients with multiple sclerosis: a double-blind randomized controlled clinical trial 2021-10-22 anticipated 50 Complete https://irct.ir/trial/58779 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Participants will be assigned to intervention and control groups using stratified permuted block randomization (block size = 4, allocation ratio = 1:1). Stratification will be done according to gender. The following website will be used for generation of random allocation sequence: https://www.sealedenvelope.com/simple-randomiser/v1/lists, Blinding description: Ginger and placebo supplements will be the same in terms of packaging, shape, color, smell, and size. N/A Multiple sclerosis. Intervention 1: Intervention group: 500 mg ginger supplements three times a day for 12 weeks. Intervention 2: Control group: 500 mg corn supplements (placebo) three times a day for 12 weeks. Yes - There is a plan to make this available What will be shared: All data will be available upon reasonable request from Prof. Reza Amani. When: 12 months after publication of results To whom: Academic users Conditions: Academic purposes Where to obtain: r_amani@nutr.mui.ac.ir How to obtain: Upon receipt of the request, the data will be sent as soon as possible. Comments:
public Reza Amani
Hezar Jerib
Isfahan Iran (Islamic Republic of) 81746-73461 +98 31 3668 1378 r_amani@nutr.mui.ac.ir Esfahan University of Medical Sciences scientific Reza Amani
Hezar Jerib
Isfahan Iran (Islamic Republic of) 81746-73461 +98 31 3668 1378 r_amani@nutr.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Having relapsing-remitting multiple sclerosis according to the 2017 revisions of the McDonald diagnostic criteria Age between 18-50 years Non-menopausal women Disability status score of less than or equal to 4.5 based on Expanded Disability Status Scale No multiple sclerosis attack or corticosteroid therapy for at least 30 days No change in multiple sclerosis medications for at least 6 months Ability and willingness to participate in the study 18 years 50 years Both Having other serious diseases such as other autoimmune disorders or cancers Pregnancy Multiple sclerosis attack or corticosteroid therapy during the intervention Change in multiple sclerosis medications during the intervention Allergic reactions to ginger or placebo supplements Consumption of less than 90% of ginger or placebo supplements G35 Multiple sclerosis Treatment - Other Placebo Intervention group: 500 mg ginger supplements three times a day for 12 weeks Control group: 500 mg corn supplements (placebo) three times a day for 12 weeks Score of disability status. Timepoint: Before and after the intervention. Method of measurement: Expanded Disability Status Scale. Serum levels of interleukin-17. Timepoint: Before and after the intervention. Method of measurement: Assay kit. Serum levels of nitric oxide metabolites. Timepoint: Before and after the intervention. Method of measurement: Assay kit. Serum levels of neurofilament light polypeptide. Timepoint: Before and after the intervention. Method of measurement: Assay kit. Serum levels of matrix metalloproteinase-9. Timepoint: Before and after the intervention. Method of measurement: Assay kit. Differential leukocyte count. Timepoint: Before and after the intervention. Method of measurement: Cell counter machine. Score of quality of life. Timepoint: Before and after the intervention. Method of measurement: Multiple Sclerosis Impact Scale. Score of gastrointestinal symptoms. Timepoint: Before and after the intervention. Method of measurement: Visual Analogue Scale. Hematological indices. Timepoint: Before and after the intervention. Method of measurement: Cell counter machine. Body mass index. Timepoint: Before and after the intervention. Method of measurement: Weighing scale and measuring tape. Esfahan University of Medical Sciences Approved 2021-09-01 Ethics Committee of Isfahan University of Medical Sciences Hezar Jerib Isfahan Isfehan Iran (Islamic Republic of)