American Ginseng Treatment for Multiple Sclerosis Related Fatigue

Multiple Sclerosis Clinical Trial

Official title:

A Double-blinded, Placebo-controlled Crossover Pilot Study of American Ginseng Treatment for Multiple Sclerosis Related Fatigue

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00754832
• Other study ID #: 1357
• Status: Completed
• Phase: Phase 2
• First received: September 16, 2008
• Last updated: January 20, 2012
• Start date: September 2005
• Est. completion date: March 2011

Study information

• Verified date: January 2012
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: March 2011
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

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.
• 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.

Locations

Country	Name	City	State
United States	Oregon Health & Science University	Portland	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
Oregon Health and Science University	National Multiple Sclerosis Society

Country where clinical trial is conducted

United States, 

References & Publications (1)

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: 10.1 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fatigue Severity Scale	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.	after 6 weeks of intervention	No
Secondary	Modified Fatigue Impact Scale	21 item scale, score range 0-84, lower scores indicate less fatigue	6 weeks of intervention	No
Secondary	Realtime Digital Fatigue Score	fatigue scored on 0-10 scale with higher scores indicating more fatigue	6 weeks of intervention	No