Multiple SclerosisPhase 2NCT00754832
American Ginseng Treatment for Multiple Sclerosis Related Fatigue
A Phase 2 study testing American ginseng extract HT-1001 in people with Multiple Sclerosis, run by Oregon Health and Science University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- American ginseng extract HT-1001
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2005to Mar 2011
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health & Science University
Portland, Oregon, 97239
About this study
Official title: A Double-blinded, Placebo-controlled Crossover Pilot Study of American Ginseng Treatment for Multiple Sclerosis Related Fatigue
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.
Read the detailed 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.
- Conditions
- Multiple Sclerosis
- Being tested
- American ginseng extract HT-1001, placebo
- Keywords
- Multiple sclerosis, fatigue, ginseng
- Medical subject headings
- Multiple Sclerosis, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
Also called placebo (matched capsules to ginseng 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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Period 1 with Ginseng therapy intervention; Washout Period with no drug; Period 2 with placebo Receives: 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 Receives: Drug: American ginseng extract HT-1001; Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: after 6 weeks of intervention
Secondary outcomes (2)
Modified Fatigue Impact Scale
21 item scale, score range 0-84, lower scores indicate less fatigue
Measured: 6 weeks of intervention
Realtime Digital Fatigue Score
fatigue scored on 0-10 scale with higher scores indicating more fatigue
Measured: 6 weeks of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2008 (estimated)
- Study startSep 2005
- Primary completionSep 2008
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Collaborators
- National Multiple Sclerosis Society
- Responsible party
- Principal investigator, Ruth Whitham, Oregon Health and Science University
- Investigators
- Ruth Whitham, M.D., Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00754832
- Sponsor's protocol ID
- 1357
- Status last verified
- Jan 2012
- First submitted
- 16 Sep 2008
- Last updated
- 24 Jan 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 21803872Kim 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.
PubMed 20803391
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blinded, Placebo-controlled Crossover Pilot Study of American Ginseng Treatment for Multiple Sclerosis Related Fatigue
- ClinicalTrials.gov ID
- NCT00754832
- Acronym / sponsor ID
- 1357
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple sclerosis, fatigue, ginseng
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Collaborators
- National Multiple Sclerosis Society
- Study start
- Sep 2005
- Primary completion
- Sep 2008 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 18 Sep 2008 (estimated)
- Results
- Posted 24 Jan 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: American ginseng extract HT-1001, Drug: placeboPeriod 1 with Ginseng therapy intervention; Washout Period with no drug; Period 2 with placebo |
| 2 | Experimental | Drug: American ginseng extract HT-1001, Drug: placeboPeriod 1 with placebo; Washout period with no drug; Period 2 with ginseng therapy intervention |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| American ginseng extract HT-1001Ginseng 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 | 1, 2 |
| placeboAlso: placebo (matched capsules to ginseng 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. | Drug | 1, 2 |
Primary outcome
Fatigue Severity Scale
Time frame: after 6 weeks of intervention
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.
2 secondary outcomes
Modified Fatigue Impact Scale
Time frame: 6 weeks of intervention
Realtime Digital Fatigue Score
Time frame: 6 weeks of intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 21803872Kim 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.
- Derived from this study: PubMed 20803391Kim 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.
Related trials for Multiple Sclerosis
RecruitingPhase 2
Metformin as an add-on or Monotherapy in Treatment of Aging People With Multiple Sclerosis (MS)
Multiple Sclerosis
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.
Stroke, Parkinson's Disease (PD)
RecruitingPhase 3
Dalfampridine Combined With Physical Therapy for Mobility Impairment in Multiple Sclerosis
Multiple Sclerosis
RecruitingPhase 2
Targeting Agonists of Glucagon-like Peptide-1 Receptor for Multiple Sclerosis
Multiple Sclerosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ruth Whitham, M.D. principal investigator
Oregon Health and Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing American ginseng extract HT-1001 in people with Multiple Sclerosis, run by Oregon Health and Science University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Jan 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fatigue Severity Scale (time frame: after 6 weeks of intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00754832, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2012.