Trial Outcomes & Findings for American Ginseng Treatment for Multiple Sclerosis Related Fatigue (NCT NCT00754832)
NCT ID: NCT00754832
Last Updated: 2012-01-24
Results Overview
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.
COMPLETED
PHASE2
56 participants
after 6 weeks of intervention
2012-01-24
Participant Flow
Participant milestones
| Measure |
Ginseng First Then Placebo
ginseng 100 mg daily escalating to 400 mg daily for 6 weeks followed by 2 weeks washout, then placebo 1 cap daily escalating to 4 caps daily for 6 weeks
|
Placebo First Then Ginseng
placebo 1 cap daily escalating to 4 caps daily for 6 weeks followed by 2 weeks washout, then ginseng 100 mg daily escalating to 400 mg daily for 6 weeks
|
|---|---|---|
|
First 6 Weeks Intervention
STARTED
|
26
|
30
|
|
First 6 Weeks Intervention
COMPLETED
|
18
|
28
|
|
First 6 Weeks Intervention
NOT COMPLETED
|
8
|
2
|
|
2 Weeks Washout
STARTED
|
18
|
28
|
|
2 Weeks Washout
COMPLETED
|
17
|
26
|
|
2 Weeks Washout
NOT COMPLETED
|
1
|
2
|
|
Second 6 Weeks Intervention
STARTED
|
17
|
26
|
|
Second 6 Weeks Intervention
COMPLETED
|
17
|
24
|
|
Second 6 Weeks Intervention
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
American Ginseng Treatment for Multiple Sclerosis Related Fatigue
Baseline characteristics by cohort
| Measure |
Intent to Treat Study Population
n=47 Participants
all participants who received at least one dose of either placebo or ginseng in this crossover trial
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
47 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
|
Age Continuous
|
46.5 years
STANDARD_DEVIATION 10.4 • n=93 Participants
|
|
Sex: Female, Male
Female
|
44 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: after 6 weeks of interventionPopulation: intention to treat
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.
Outcome measures
| Measure |
Ginseng
n=47 Participants
ginseng 100 mg daily escalating to 400 mg daily for 6 weeks
|
Placebo
n=47 Participants
placebo 1 tab daily escalating to 4 tabs daily for 6 weeks
|
|---|---|---|
|
Fatigue Severity Scale
|
5.5 units on a scale
Standard Deviation 1.3
|
5.5 units on a scale
Standard Deviation 1.3
|
SECONDARY outcome
Timeframe: 6 weeks of intervention21 item scale, score range 0-84, lower scores indicate less fatigue
Outcome measures
| Measure |
Ginseng
n=47 Participants
ginseng 100 mg daily escalating to 400 mg daily for 6 weeks
|
Placebo
n=47 Participants
placebo 1 tab daily escalating to 4 tabs daily for 6 weeks
|
|---|---|---|
|
Modified Fatigue Impact Scale
|
42.7 units on a scale
Standard Deviation 15.7
|
43.7 units on a scale
Standard Deviation 16.7
|
SECONDARY outcome
Timeframe: 6 weeks of interventionfatigue scored on 0-10 scale with higher scores indicating more fatigue
Outcome measures
| Measure |
Ginseng
n=47 Participants
ginseng 100 mg daily escalating to 400 mg daily for 6 weeks
|
Placebo
n=47 Participants
placebo 1 tab daily escalating to 4 tabs daily for 6 weeks
|
|---|---|---|
|
Realtime Digital Fatigue Score
|
4.2 units on a scale
Standard Deviation 1.6
|
4.2 units on a scale
Standard Deviation 1.8
|
Adverse Events
Ginseng
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Ginseng
n=56 participants at risk
ginseng 100 mg daily escalating to 400 mg daily for 6 weeks
|
Placebo
n=56 participants at risk
placebo 1 tab daily escalating to 4 tabs daily for 6 weeks
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
rash
|
5.4%
3/56
|
0.00%
0/56
|
|
Psychiatric disorders
insomnia
|
5.4%
3/56
|
7.1%
4/56
|
|
Nervous system disorders
headache
|
5.4%
3/56
|
1.8%
1/56
|
|
Gastrointestinal disorders
nausea
|
7.1%
4/56
|
7.1%
4/56
|
|
General disorders
flu like syndrome
|
5.4%
3/56
|
3.6%
2/56
|
|
Infections and infestations
upper respiratory infection
|
1.8%
1/56
|
5.4%
3/56
|
Additional Information
Dr. Michelle Cameron
Oregon Health & Science University
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place