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
What it found
Results are posted in the registry, but without a statistical test of the main measure. See the numbers below.
What was tested
Treatment tested
- American ginseng extract HT-1001
Placebo
- placebo
Results by group
Fatigue Severity Scale
after 6 weeks of intervention
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Ginseng | 5.5 units on a scale | 1.3 (Standard Deviation) | 47 |
| Placebo | 5.5 units on a scale | 1.3 (Standard Deviation) | 47 |
Ginseng
Placebo
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| Ginseng | 56 | 0 (0.0%) | |
| Placebo | 56 | 0 (0.0%) |
As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.
What it measured
Main measures
Fatigue Severity Scale
after 6 weeks of intervention
Fatigue
Other measures (2)
Modified Fatigue Impact Scale
6 weeks of intervention
FatigueRealtime Digital Fatigue Score
6 weeks of intervention
Fatigue
Who could take part
MS (type not specified) · 18 to 70
Show the full criteria
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
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
Results
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.Results
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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History
Started
Sept 2005
Main results due
Sept 2008
Finished
Mar 2011
Results posted
Jan 2012