CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 56 enrolled
Drug / intervention
American ginseng extract HT-1001 +1 moredrug
Likely dose
American ginseng extract HT-1001 100 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00754832
NCT00754832Phase 2Completed
CompareCT.gov

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

Oregon Health and Science University·interventional·Posted Sep 18, 2008·Updated Jan 24, 2012

In Brief

A Phase 2 clinical trial evaluating American ginseng extract HT-1001 and placebo for Multiple Sclerosis. Completed, enrolled 56 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMultiple Sclerosis
CountriesUnited States
CollaboratorsNational Multiple Sclerosis Society

Timeline

Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 18, 2008
Enrollment StartSep 1, 2005
Primary CompletionSep 1, 2008
Study CompletionMar 1, 2011
TodayJul 2, 2026
Enrollment to primary: 3 yearsPosted 17.8 years ago

Interventions

American ginseng extract HT-1001drug

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.

placebodrug

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.