The efficacy and safety of ginger supplementation in patients with multiple sclerosis: A rationale and study protocol for a double-blind randomized controlled trial

Abstract

Background and AimsMultiple sclerosis (MS) is a chronic disease characterized by axonal damage, demyelination, inflammation, oxidative stress, and immune cell infiltration. This disease is the first cause of nontraumatic disability in young adults leading to a decline in patients' quality of life. Patients with MS may also suffer from gastrointestinal symptoms due to the disease or prescription drugs. Unfortunately, no treatment for MS has been discovered yet, and prescribed drugs can only help control its clinical course. Interestingly, recent animal studies have shown positive effects of ginger administration in the MS model. Therefore, we aim to determine the effect of ginger supplementation on neurofilament light chain, matrix metalloproteinase-9, interleukin-17, nitric oxide, complete and differential blood counts, disability status, quality of life, gastrointestinal symptoms, and body mass index (BMI) in MS patients. MethodsThis study is a double-blind randomized controlled trial. Fifty-two patients with relapsing-remitting MS will be assigned to intervention and control groups using stratified permuted block randomization. The intervention and control groups will take 1500 mg/day ginger and placebo (as corn) supplements for 12 weeks, respectively. All outcomes will be assessed before and after the trial. Serum concentrations of neurofilament light chain, matrix metalloproteinase-9, and interleukin-17 will be measured by enzyme-linked immunosorbent assay. Nitric oxide serum levels will be detected using colorimetry. Complete and differential blood counts will be assessed by an automated hematology analyzer. Disability status, quality of life, and gastrointestinal symptoms will be evaluated by the Expanded Disability Status Scale, MS Impact Scale, and Visual Analog Scale, respectively. BMI will be calculated by dividing weight in kilograms by height in meters squared. Potential side effects of ginger supplementation will also be closely monitored during the study. Trial RegistrationThis protocol was registered at the Iranian Registry of Clinical Trials () under the registration number IRCT20180818040827N3.