Mode
Home
Research
Clinical Trials Drug Pipeline Weekly Digests
Reference
Conditions Medications
Community
Questions
Text Size
Log in / Sign up
Phase 2 N=56 Randomized Quadruple-blind Treatment

American Ginseng Treatment for Multiple Sclerosis Related Fatigue

Multiple Sclerosis

Bottom Line

View on ClinicalTrials.gov: NCT00754832 ↗
Enrolled (actual)
56
Serious AEs
0.0%
Results posted
Jan 2012
Primary outcome: Primary: Fatigue Severity Scale — 5.5; 5.5 units on a scale

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
American ginseng extract HT-1001 (Drug); placebo (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Oregon Health and Science University
Primary completion
Sep 2008

Outcome Measures

OutcomeResultp-value
PRIMARY
Fatigue Severity Scale		 5.5; 5.5 —
SECONDARY
Modified Fatigue Impact Scale		 42.7; 43.7 —
SECONDARY
Realtime Digital Fatigue Score		 4.2; 4.2 —

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.

Eligibility 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00754832). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

Back to search