- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00754832
American Ginseng Treatment for Multiple Sclerosis Related Fatigue
A Double-blinded, Placebo-controlled Crossover Pilot Study of American Ginseng Treatment for Multiple Sclerosis Related Fatigue
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
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Oregon
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Portland, Oregon, United States, 97239
- Oregon Health & Science University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
Period 1 with Ginseng therapy intervention; Washout Period with no drug; Period 2 with placebo
|
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 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:
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Experimental: 2
Period 1 with placebo; Washout period with no drug; Period 2 with ginseng therapy intervention
|
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 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:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
after 6 weeks of intervention
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Modified Fatigue Impact Scale
Time Frame: 6 weeks of intervention
|
21 item scale, score range 0-84, lower scores indicate less fatigue
|
6 weeks of intervention
|
Realtime Digital Fatigue Score
Time Frame: 6 weeks of intervention
|
fatigue scored on 0-10 scale with higher scores indicating more fatigue
|
6 weeks of intervention
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Ruth Whitham, M.D., Oregon Health and Science University
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1357
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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