Multiple Sclerosis Clinical Trial
Official title:
A Double-blinded, Placebo-controlled Crossover Pilot Study of American Ginseng Treatment for Multiple Sclerosis Related Fatigue
This research project will determine the safety and tolerability of ginseng in subjects with MS and will gather preliminary data on the efficacy of ginseng vs placebo for the treatment of MS fatigue.
Fatigue is a major cause of disability in MS and is associated with a reduced quality of
life. Treatment options for MS fatigue include central nervous system stimulants and
amantadine. These medications are of limited efficacy, are often poorly tolerated, and can
be expensive. Ginseng may represent a novel approach to treating MS fatigue. Ginseng has
been tested in clinical trials for its ability to improve mental alertness and fatigue.
However, there have been no published clinical trials addressing the effects of ginseng in
subjects with MS, even though many people with MS use ginseng and report deriving benefit
from it.
This double-blinded, placebo controlled crossover pilot study will determine the safety and
tolerability of ginseng in subjects with MS and will gather preliminary data on the efficacy
of ginseng vs. placebo for the treatment of MS fatigue. Additionally, the project will
collect information on the impact of ginseng on cognition, stress, actigraphy, salivary
cortisol, differential cytokine response, and quality of life.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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