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American Ginseng Treatment for Multiple Sclerosis Related Fatigue

NCT00754832 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2012-01-24

Study results available
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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

Interventions

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.

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.

Sponsors & Collaborators

  • National Multiple Sclerosis Society

    collaborator OTHER

  • Oregon Health and Science University

    lead OTHER

Principal Investigators

  • Ruth Whitham, M.D. · Oregon Health and Science University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-09-30
Primary Completion
2008-09-30
Completion
2011-03-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00754832 on ClinicalTrials.gov