Trial Testing Safety, Efficacy of Ginger Supplements in RRMS
Ginger extracts have shown some promise in animal models of MS
Researchers in Iran are conducting a clinical trial to test the effects of taking ginger supplements for people with relapsing-remitting multiple sclerosis (RRMS).
Ginger extracts have shown some promise in animal models of multiple sclerosis (MS), but no trial has yet determined the impact that ginger supplements may have in this patient population.
Now, a placebo-controlled trial is testing their safety and efficacy.
“The findings of this study will be helpful for people with or at risk of MS, researchers, and clinicians,” the team wrote in a new study where they detailed the trial’s protocol and goals.
The study, “The efficacy and safety of ginger supplementation in patients with multiple sclerosis: A rationale and study protocol for a double-blind randomized controlled trial,” was published in Health Science Reports.
Ginger has long history in traditional medicine
The ginger plant has been used by humans for millennia. As a spice, it plays an important role in many types of cuisines, and it also has been used in traditional medicine practices. The most common uses for ginger in traditional medicine include easing digestive problems and reducing pain related to inflammation.
In a series of studies published between 2014 and 2017, a team led by researchers at Kerman University of Medical Sciences, in Iran, demonstrated that injections of ginger extract had beneficial effects in a mouse model of MS. The results suggested that the ginger treatment reduced disease-driving inflammation and lessened the resulting damage in the nervous system that gives rise to MS symptoms.
However, “despite the promising effects of supplementation with ginger in the MS animal model, to the best of our knowledge, no randomized controlled trial (RCT) has been conducted on this topic,” the researchers wrote.
To address this knowledge gap, the team is conducting a double-blind clinical trial (IRCT20180818040827N3) — one in which neither scientists nor participants know which patients are receiving the ginger supplements and which the placebo. The study, which launched in early 2022, is sponsored by Isfahan University of Medical Sciences, also in Iran.
The study was planned to include 52 adults with RRMS, between ages 18 and 50, who are on stable treatment without recent relapse activity. After a three-week run-in period, participants are assigned to take either 500 mg ginger supplements, or a placebo, three times daily for 12 weeks, or about three months.
Participants in both groups are directed to maintain their normal dietary and physical activity habits, though all are asked to refrain from consuming foods that contain ginger as a spice.
A number of metrics will be assessed before and after the 12-week intervention period. MS-related disability will be assayed using the Expanded Disability Status Scale (EDSS), and life quality will be measured using the MS Impact Scale (MSIS-29), both of which are established standardized measures of disability.
The severity of a number of digestive problems — such as heartburn, nausea, vomiting, constipation, and diarrhea — will be rated by patients on a scale from 0 to 100. Body mass index (BMI), a ratio of weight to height, also will be tracked.
Levels of several MS-related biomarkers in participants’ blood also will be assessed. These include neurofilament light chain (NfL), a marker of nerve damage, as well as several markers related to inflammation, like matrix metalloproteinase-9, interleukin-17, and nitric oxide.
Consuming ginger at levels up to 4,000 mg per day is generally considered safe, according to the U.S. Food and Drug Administration. Nonetheless, as this is the first study of ginger supplementation in MS patients, researchers said they will closely monitor participants for any side effects associated with the supplements.
“Throughout the study, the patients will be encouraged to contact the principal investigator if they suspect any complaint related to the intervention,” the team wrote. “In addition, the participants will be asked to report side effects and adverse events in weekly phone calls or text messages. Moreover, they will be interviewed for possible side effects (abdominal discomfort, heartburn, diarrhea, etc.) in face-to-face visits at the middle and end of the trial.”