American Ginseng Treatment for Multiple Sclerosis Related Fatigue

NCT00754832 | Completed Phase 2 Results

• 1 other identifier: 1357
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Keywords

Multiple sclerosis; fatigue; ginseng

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Modified Fatigue Impact Scale

  6 weeks of intervention

• Realtime Digital Fatigue Score

  6 weeks of intervention

Study Arms (2)

1

EXPERIMENTAL

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

Drug: American ginseng extract HT-1001; Drug: placebo

2

EXPERIMENTAL

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

Drug: American ginseng extract HT-1001; Drug: placebo

Interventions

American ginseng extract HT-1001 DRUG

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.

1; 2

placebo DRUG

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.

Also known as: placebo (matched capsules to ginseng drug)

1; 2

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Oregon Health and Science University: lead
• National Multiple Sclerosis Society: collaborator

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

Related Publications (2)

• 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: 10.1177/1352458511412062. Epub 2011 Jul 29.

  PMID: 21803872 RESULT

• 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. doi: 10.1682/jrrd.2009.09.0151.

  PMID: 20803391 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis; Fatigue

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Michelle Cameron
• Organization: Oregon Health & Science University

cameromi@ohsu.edu

503-418-1971

Study Officials

• Ruth Whitham, M.D.

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Neurology

Study Record Dates

• First Submitted: September 16, 2008
• First Posted: September 18, 2008
• Study Start: September 1, 2005
• Primary Completion: September 1, 2008
• Study Completion: March 1, 2011
• Last Updated: January 24, 2012
• Results First Posted: January 24, 2012

Record last verified: 2012-01

Locations

US (1)