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Study aim
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To determine 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
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Design
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This study will be a parallel double-blind randomized controlled clinical trial with a sample size of 50 people. The randomization will be done using a web-based randomization service.
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Settings and conduct
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Fifty patients with multiple sclerosis will be recruited from Imam Reza Clinic, Shiraz, Iran. The intervention and control groups will receive ginger and placebo supplements for 12 weeks, respectively. Ginger and placebo supplements will be the same in terms of packaging, shape, color, smell, and size. Participants, care providers, investigators, and outcome assessors will be blinded. The main outcomes will be measured before and after the intervention.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria:
1) Having relapsing-remitting multiple sclerosis according to the 2017 revisions of the McDonald diagnostic criteria
2) Age between 18-50 years
3) Disability status score of less than or equal to 4.5 based on Expanded Disability Status Scale.
Exclusion criteria:
1) Having other serious diseases such as other autoimmune disorders or cancers
2) Pregnancy
3) Consumption of less than 90% of ginger or placebo supplements
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Intervention groups
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1) Intervention group: 500 mg ginger supplements three times a day for 12 weeks.
2) Control group: 500 mg corn supplements (placebo) three times a day for 12 weeks
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Main outcome variables
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Neurofilament light polypeptide, matrix metalloproteinase-9, interleukin-17, nitric oxide metabolites, differential leukocyte count, disability status, quality of life, gastrointestinal symptoms, hematological indices, and body mass index