Status:
COMPLETED
American Ginseng Treatment for Multiple Sclerosis Related Fatigue
Lead Sponsor:
Oregon Health and Science University
Collaborating Sponsors:
National Multiple Sclerosis Society
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
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 medicati...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT00754832
Start Date
September 1 2005
End Date
March 1 2011
Last Update
January 24 2012
Active Locations (1)
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1
Oregon Health & Science University
Portland, Oregon, United States, 97239