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| Name | Class |
|---|---|
| National Multiple Sclerosis Society | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Period 1 with Ginseng therapy intervention; Washout Period with no drug; Period 2 with placebo |
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| 2 | Experimental | Period 1 with placebo; Washout period with no drug; Period 2 with ginseng therapy intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ruth Whitham, M.D. | Oregon Health and Science University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oregon Health & Science University | Portland | Oregon | 97239 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21803872 | Result | 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. | |
| 20803391 | Derived |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ginseng First Then Placebo | ginseng 100 mg daily escalating to 400 mg daily for 6 weeks followed by 2 weeks washout, then placebo 1 cap daily escalating to 4 caps daily for 6 weeks |
| FG001 | Placebo First Then Ginseng | placebo 1 cap daily escalating to 4 caps daily for 6 weeks followed by 2 weeks washout, then ginseng 100 mg daily escalating to 400 mg daily for 6 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First 6 Weeks Intervention |
| |||||||||||||
| 2 Weeks Washout |
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| Second 6 Weeks Intervention |
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| ID | Title | Description |
|---|---|---|
| BG000 | Intent to Treat Study Population | all participants who received at least one dose of either placebo or ginseng in this crossover trial |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | intention to treat | Posted | Mean | Standard Deviation | units on a scale | after 6 weeks of intervention |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ginseng | ginseng 100 mg daily escalating to 400 mg daily for 6 weeks |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Michelle Cameron | Oregon Health & Science University | 503-418-1971 | cameromi@ohsu.edu |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D005221 | Fatigue |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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|
| 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. |
|
|
| 6 weeks of intervention |
| 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. |
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| NOT COMPLETED |
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| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
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| Secondary | Modified Fatigue Impact Scale | 21 item scale, score range 0-84, lower scores indicate less fatigue | Posted | Mean | Standard Deviation | units on a scale | 6 weeks of intervention |
|
|
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| Secondary | Realtime Digital Fatigue Score | fatigue scored on 0-10 scale with higher scores indicating more fatigue | Posted | Mean | Standard Deviation | units on a scale | 6 weeks of intervention |
|
|
|
| 0 |
| 56 |
| 5 |
| 56 |
| EG001 | Placebo | placebo 1 tab daily escalating to 4 tabs daily for 6 weeks | 0 | 56 | 4 | 56 |
| insomnia | Psychiatric disorders |
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| headache | Nervous system disorders |
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| nausea | Gastrointestinal disorders |
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| flu like syndrome | General disorders |
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| upper respiratory infection | Infections and infestations |
|
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| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |