American Ginseng Treatment for Multiple Sclerosis Related Fatigue

Oregon Health & Science University (OHSU)

Status and phase: Completed; Phase 2

Conditions: Multiple Sclerosis

Treatments: Drug: American ginseng extract HT-1001; Drug: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00754832

1357

Details and patient eligibility

About

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.

Full 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.

Enrollment: 56 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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56 participants in 2 patient groups

1

Experimental group

Description:

Period 1 with Ginseng therapy intervention; Washout Period with no drug; Period 2 with placebo

Treatment:

Drug: placebo

Drug: American ginseng extract HT-1001

2

Experimental group

Description:

Period 1 with placebo; Washout period with no drug; Period 2 with ginseng therapy intervention

Treatment:

Drug: placebo

Drug: American ginseng extract HT-1001