Phase 2
Completed N=56
American Ginseng Treatment for Multiple Sclerosis Related Fatigue
Source: ClinicalTrials.gov NCT00754832 ↗Enrolled (actual)
56
Serious AEs
0.0%
Results posted
Jan 2012
Primary outcomePrimary: Fatigue Severity Scale — 5.5; 5.5 units on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Fatigue Severity Scale |
5.5; 5.5 | — |
| SECONDARY Modified Fatigue Impact Scale |
42.7; 43.7 | — |
| SECONDARY Realtime Digital Fatigue Score |
4.2; 4.2 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00754832). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.