American Ginseng Treatment for Multiple Sclerosis Related Fatigue - Full Text View

Sponsors and Collaborators:	Oregon Health and Science University National Multiple Sclerosis Society
Information provided by:	Oregon Health and Science University
ClinicalTrials.gov Identifier:	NCT00754832

Purpose

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.

Condition	Intervention	Phase
Multiple Sclerosis	Drug: American ginseng extract HT-1001	Phase II

MedlinePlus related topics: Multiple Sclerosis

Drug Information available for: Ginseng American ginseng extract

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Safety/Efficacy Study
Official Title:	A Double-Blinded, Placebo-Controlled Crossover Pilot Study of American Ginseng Treatment for Multiple Sclerosis Related Fatigue

Further study details as provided by Oregon Health and Science University:

Primary Outcome Measures:

Fatigue Severity Scale [ Time Frame: Week 0, 3, 9, 11, 17 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Modified Fatigue Impact Scale [ Time Frame: Week 0, 3, 9, 11, 17 ] [ Designated as safety issue: No ]
Beck Depression Inventory [ Time Frame: Week 0, 3, 9, 11, 17 ] [ Designated as safety issue: No ]
Actiwatch Fatigue Score [ Time Frame: Weeks 0-3, 3-9, 11-17 ] [ Designated as safety issue: No ]
Actical Activity Monitoring [ Time Frame: Weeks 0-3, 3-9, 11-17 ] [ Designated as safety issue: No ]

Enrollment:	56
Study Start Date:	September 2005
Estimated Study Completion Date:	December 2008
Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Period 1 with Ginseng therapy intervention; Washout Period with no drug; Period 2 with placebo	Drug: American ginseng extract HT-1001 Ginseng HT-1001 will be 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 will be maintained on 400 mg per day or the maximum tolerated dose for the remainder of the 6 week treatment period.
2: Experimental Period 1 with placebo; Washout period with no drug; Period 2 with ginseng therapy intervention	Drug: American ginseng extract HT-1001 Ginseng HT-1001 will be 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 will be maintained on 400 mg per day or the maximum tolerated dose for the remainder of the 6 week treatment period.

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.

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00754832

Locations

United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239

Sponsors and Collaborators

Oregon Health and Science University

National Multiple Sclerosis Society

Investigators

Principal Investigator:

Ruth Whitham, M.D.

Oregon Health and Science University

More Information

Responsible Party:	Oregon Health & Science University ( Ruth Whitham/ Principal Investigator )
Study ID Numbers:	1357
Study First Received:	September 16, 2008
Last Updated:	October 14, 2008
ClinicalTrials.gov Identifier:	NCT00754832
Health Authority:	United States: Institutional Review Board

Keywords provided by Oregon Health and Science University:

Multiple sclerosis
fatigue
ginseng

Study placed in the following topic categories:

Autoimmune Diseases
Fatigue
Multiple Sclerosis
Demyelinating Diseases

Demyelinating Autoimmune Diseases, CNS
Demyelinating diseases
Sclerosis
Autoimmune Diseases of the Nervous System

Additional relevant MeSH terms:

Pathologic Processes
Immune System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on January 13, 2009