Multiple Sclerosis
Conditions
Keywords
Multiple sclerosis, fatigue, ginseng
Brief summary
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
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.
Interventions
DRUGAmerican ginseng extract HT-1001
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.
DRUGplacebo
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.
Sponsors
National Multiple Sclerosis Society
Oregon Health and Science University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fatigue Severity Scale | 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
| Measure | Time frame | Description |
|---|---|---|
| Modified Fatigue Impact Scale | 6 weeks of intervention | 21 item scale, score range 0-84, lower scores indicate less fatigue |
| Realtime Digital Fatigue Score | 6 weeks of intervention | fatigue scored on 0-10 scale with higher scores indicating more fatigue |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intent to Treat Study Population all participants who received at least one dose of either placebo or ginseng in this crossover trial | 47 |
| Total | 47 |
Baseline characteristics
| Characteristic | Intent to Treat Study Population |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 47 Participants |
| Age Continuous | 46.5 years STANDARD_DEVIATION 10.4 |
| Sex: Female, Male Female | 44 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 5 / 56 | 4 / 56 |
| serious Total, serious adverse events | 0 / 56 | 0 / 56 |
Outcome results
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.
Time frame: after 6 weeks of intervention
Population: intention to treat
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ginseng | Fatigue Severity Scale | 5.5 units on a scale | Standard Deviation 1.3 |
| Placebo | Fatigue Severity Scale | 5.5 units on a scale | Standard Deviation 1.3 |
Secondary
Modified Fatigue Impact Scale
21 item scale, score range 0-84, lower scores indicate less fatigue
Time frame: 6 weeks of intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ginseng | Modified Fatigue Impact Scale | 42.7 units on a scale | Standard Deviation 15.7 |
| Placebo | Modified Fatigue Impact Scale | 43.7 units on a scale | Standard Deviation 16.7 |
Secondary
Realtime Digital Fatigue Score
fatigue scored on 0-10 scale with higher scores indicating more fatigue
Time frame: 6 weeks of intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ginseng | Realtime Digital Fatigue Score | 4.2 units on a scale | Standard Deviation 1.6 |
| Placebo | Realtime Digital Fatigue Score | 4.2 units on a scale | Standard Deviation 1.8 |