American Ginseng Treatment for Multiple Sclerosis Related Fatigue

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Drug: American ginseng extract HT-1001
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Period 1 with Ginseng therapy intervention; Washout Period with no drug; Period 2 with placebo | Drug: American ginseng extract HT-1001<br>* 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.<br>Drug: placebo<br>* 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.<br>* Other names: placebo (matched capsules to ginseng drug);|
| Experimental: 2<br>Period 1 with placebo; Washout period with no drug; Period 2 with ginseng therapy intervention | Drug: American ginseng extract HT-1001<br>* 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.<br>Drug: placebo<br>* 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.<br>* Other names: placebo (matched capsules to ginseng drug);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fatigue Severity Scale | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modified Fatigue Impact Scale | 21 item scale, score range 0-84, lower scores indicate less fatigue | 6 weeks of intervention | 
| Realtime Digital Fatigue Score | fatigue scored on 0-10 scale with higher scores indicating more fatigue | 6 weeks of intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Multiple sclerosis, fatigue, ginseng