Clinical trial NCT00754832: American Ginseng Treatment for Multiple Sclerosis Related Fatigue
Official title: A Double-blinded, Placebo-controlled Crossover Pilot Study of American Ginseng Treatment for Multiple Sclerosis Related Fatigue
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Multiple Sclerosis
Keywords: Multiple sclerosis
fatigue
ginseng
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
Collaborators: name: National Multiple Sclerosis Society
First posted: 2008-09-18
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* MS as diagnosed by the McDonald criteria
* Complaint of fatigue that has been persistent for at least 2 months
* FSS score of 4 or greater;
* Age 18-70.

Exclusion Criteria:

* Use of ginseng or stimulants in the prior 6 weeks
* Acute treatment with glucocorticoids in the prior 6 weeks
* BDI \>31
* Significant MS exacerbation in prior 30 days
* Diabetes
* Uncontrolled hypertension
* Other serious medical disease, pregnancy or breastfeeding
* Breast disease
* Abnormal bleeding or clotting disorder
* Current use of warfarin, albendazole, nifedipine, digoxin, bumetadine, selegiline, isocarboxazid, or phenelzine
* Current use of lasix for poorly controlled hypertension or congestive heart failure
* Current drug or alcohol abuse; inability to complete the self report forms

Primary outcomes:
measure: Fatigue Severity Scale
timeFrame: after 6 weeks of intervention
Secondary outcomes:
measure: Modified Fatigue Impact Scale
timeFrame: 6 weeks of intervention
measure: Realtime Digital Fatigue Score
timeFrame: 6 weeks of intervention
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Ruth Whitham, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kim E, Cameron M, Lovera J, Schaben L, Bourdette D, Whitham R. American ginseng does not improve fatigue in multiple sclerosis: a single center randomized double-blind placebo-controlled crossover pilot study. Mult Scler. 2011 Dec;17(12):1523-6. doi: 10.1177/1352458511412062. Epub 2011 Jul 29.
citation: Kim E, Lovera J, Schaben L, Melara J, Bourdette D, Whitham R. Novel method for measurement of fatigue in multiple sclerosis: Real-Time Digital Fatigue Score. J Rehabil Res Dev. 2010;47(5):477-84. doi: 10.1682/jrrd.2009.09.0151.