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Completed

NCT Number: NCT00754832

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Oregon Health & Science University

Portland, Oregon, 97239, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

American ginseng extract HT-1001

Drug

Ginseng HT-1001 was dosed at 100 mg orally per day initially, increased after one week to 200 mg per day, then further increased the next week to 400 mg per day as tolerated. Subjects were then maintained on 400 mg per day or the maximum tolerated dose for the remainder of the 6 week treatment period.

Placebo

Drug

Placebo capsules were identical to the study drug and were dose escalated to match the study drug. Subjects were maintained on placebo capsules for the remainder of the 6 week treatment period.

Other names: placebo (matched capsules to ginseng drug)

Primary outcomes

  1. Fatigue Severity Scale

    Time frame: after 6 weeks of intervention

    The Fatigue Severity Scale (FSS)is a self-administered instrument that includes 9 items rated on a 7-point scale, measuring fatigue severity. The subject is asked to score each statement, based on how the statement applied to them over the preceding week. The fatigue severity score is the average of the scores on the 9 questions; scores range from 1-7, with lower scores indicating less fatigue.

Secondary outcomes

  1. Modified Fatigue Impact Scale

    Time frame: 6 weeks of intervention

    21 item scale, score range 0-84, lower scores indicate less fatigue

  2. Realtime Digital Fatigue Score

    Time frame: 6 weeks of intervention

    fatigue scored on 0-10 scale with higher scores indicating more fatigue

Sponsors and collaborators

Lead sponsor

Oregon Health and Science University

Other

Collaborators

  • National Multiple Sclerosis Society

Registry information

Official study title

A Double-blinded, Placebo-controlled Crossover Pilot Study of American Ginseng Treatment for Multiple Sclerosis Related Fatigue

Important dates

Study start
2005
Primary completion
2008
Study completion
2011
First posted
Sep 18, 2008
Registry last updated
Jan 24, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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