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

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 Drug: placebo	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Double-blinded, Placebo-controlled Crossover Pilot Study of American Ginseng Treatment for Multiple Sclerosis Related Fatigue

Resource links provided by NLM:

Genetics Home Reference related topics: multiple sclerosis

MedlinePlus related topics: Fatigue Multiple Sclerosis

Drug Information available for: American ginseng extract

U.S. FDA Resources

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

Primary Outcome Measures:

Fatigue Severity Scale [ Time Frame: after 6 weeks of intervention ] [ Designated as safety issue: No ]
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 Outcome Measures:

Modified Fatigue Impact Scale [ Time Frame: 6 weeks of intervention ] [ Designated as safety issue: No ]
21 item scale, score range 0-84, lower scores indicate less fatigue
Realtime Digital Fatigue Score [ Time Frame: 6 weeks of intervention ] [ Designated as safety issue: No ]
fatigue scored on 0-10 scale with higher scores indicating more fatigue

Enrollment:	56
Study Start Date:	September 2005
Study Completion Date:	March 2011
Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Period 1 with Ginseng therapy intervention; Washout Period with no drug; Period 2 with placebo	Drug: American 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. Other Name: American Ginseng Extract HT-1001 Drug: placebo 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. Other Name: placebo (matched capsules to ginseng drug)
Experimental: 2 Period 1 with placebo; Washout period with no drug; Period 2 with ginseng therapy intervention	Drug: American 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. Other Name: American Ginseng Extract HT-1001 Drug: placebo 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. Other Name: placebo (matched capsules to ginseng drug)

Arms

Assigned Interventions

Experimental: 1

Period 1 with Ginseng therapy intervention; Washout Period with no drug; Period 2 with placebo

Drug: American 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.

Other Name: American Ginseng Extract HT-1001

Drug: placebo

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.

Other Name: placebo (matched capsules to ginseng drug)

Experimental: 2

Period 1 with placebo; Washout period with no drug; Period 2 with ginseng therapy intervention

Drug: American 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.

Other Name: American Ginseng Extract HT-1001

Drug: placebo

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.

Other Name: placebo (matched capsules to ginseng drug)

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

Publications:

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. Epub 2011 Jul 29.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Responsible Party:	Ruth Whitham, Professor of Neurology, Oregon Health and Science University
ClinicalTrials.gov Identifier:	NCT00754832 History of Changes
Other Study ID Numbers:	1357
Study First Received:	September 16, 2008
Results First Received:	September 9, 2011
Last Updated:	January 20, 2012
Health Authority:	United States: Institutional Review Board

Keywords provided by Oregon Health and Science University:

Multiple sclerosis
fatigue
ginseng

Additional relevant MeSH terms:

Fatigue
Multiple Sclerosis
Sclerosis
Signs and Symptoms
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System

Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on June 17, 2013