Trial Outcomes & Findings for Immunologic Effects of Echinacea (NCT NCT00860795)
NCT ID: NCT00860795
Last Updated: 2018-05-01
Results Overview
tumor necrosis factor alpha NK cells and evidence of CD25/69 activation
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
20 participants
Primary outcome timeframe
10 days
Results posted on
2018-05-01
Participant Flow
Healthy adults were recruited using general advertising and enrolled between March and August 2009
Participant milestones
| Measure |
Echinacea
25 ml daily in 2 divided doses for 10 days
|
Placebo
25 ml daily in 2 divided doses for 10 days
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
|
Overall Study
Number to Complete Study Medication
|
9
|
10
|
|
Overall Study
COMPLETED
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Immunologic Effects of Echinacea
Baseline characteristics by cohort
| Measure |
Echinacea
n=10 Participants
25 ml daily in 2 divided doses for 10 days
|
Placebo
n=10 Participants
25 ml daily in 2 divided doses for 10 days
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
35.5 years
STANDARD_DEVIATION 12.6 • n=5 Participants
|
37.4 years
STANDARD_DEVIATION 14.3 • n=7 Participants
|
36.5 years
STANDARD_DEVIATION 13.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
10 participants
n=7 Participants
|
20 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 10 daysPopulation: Intention to treat
tumor necrosis factor alpha NK cells and evidence of CD25/69 activation
Outcome measures
| Measure |
Echinacea
n=10 Participants
25 ml daily in 2 divided doses for 10 days
|
Placebo
n=10 Participants
25 ml daily in 2 divided doses for 10 days
|
|---|---|---|
|
Maximal Level of Tumor Necrosis Factor Alpha (pg/ml)
|
2694 tumor necrosis alpha level (pg/ml)
Standard Deviation 1299
|
2648 tumor necrosis alpha level (pg/ml)
Standard Deviation 1625
|
SECONDARY outcome
Timeframe: 10 daysPopulation: Intention to treat
interferon alpha was measured on days 2, 3, 7, 10 in peripheral blood mononuclear cells. The highest level on any of these days in each participant was chosen as the maximal level and used for the analysis.
Outcome measures
| Measure |
Echinacea
n=10 Participants
25 ml daily in 2 divided doses for 10 days
|
Placebo
n=10 Participants
25 ml daily in 2 divided doses for 10 days
|
|---|---|---|
|
Maximal Levels of Interferon Alpha (pg/ml)
|
29 interferon alpha level (pg/ml)
Standard Deviation 47
|
35 interferon alpha level (pg/ml)
Standard Deviation 69
|
SECONDARY outcome
Timeframe: 10 daysPopulation: intention to treat
NK cells with evidence of CD25/69 activation were assessed on days 2, 3, 7, and 10. The highest percentage found on one of these days in each participant was categorized as the the maximal CD25/69 activation
Outcome measures
| Measure |
Echinacea
n=10 Participants
25 ml daily in 2 divided doses for 10 days
|
Placebo
n=10 Participants
25 ml daily in 2 divided doses for 10 days
|
|---|---|---|
|
Maximal CD25/69 Activation (% of NK CD25/69+ Cells)
|
1.07 (% of NK CD25/69+ cells)
Standard Deviation .70
|
1.53 (% of NK CD25/69+ cells)
Standard Deviation 1.10
|
SECONDARY outcome
Timeframe: 30 daysPopulation: intention to treat
Outcome measures
| Measure |
Echinacea
n=10 Participants
25 ml daily in 2 divided doses for 10 days
|
Placebo
n=10 Participants
25 ml daily in 2 divided doses for 10 days
|
|---|---|---|
|
Adverse Effects
diarrhea
|
0 participants
|
1 participants
|
|
Adverse Effects
constipation
|
1 participants
|
1 participants
|
|
Adverse Effects
blurred vision
|
1 participants
|
1 participants
|
|
Adverse Effects
gas/indigestion
|
1 participants
|
2 participants
|
|
Adverse Effects
nausea
|
4 participants
|
1 participants
|
|
Adverse Effects
taste: abnormal/metallic
|
1 participants
|
1 participants
|
|
Adverse Effects
musculoskeletal pain
|
0 participants
|
1 participants
|
|
Adverse Effects
headache
|
0 participants
|
3 participants
|
|
Adverse Effects
fever
|
1 participants
|
0 participants
|
|
Adverse Effects
sore throat
|
0 participants
|
1 participants
|
|
Adverse Effects
nasal congestion
|
1 participants
|
1 participants
|
|
Adverse Effects
rash
|
1 participants
|
1 participants
|
|
Adverse Effects
anxiety
|
1 participants
|
2 participants
|
|
Adverse Effects
insomnia
|
0 participants
|
1 participants
|
|
Adverse Effects
weakness/fatigue
|
1 participants
|
1 participants
|
|
Adverse Effects
urinary: difficult/painful
|
0 participants
|
1 participants
|
|
Adverse Effects
other
|
4 participants
|
2 participants
|
SECONDARY outcome
Timeframe: 10 daysPopulation: intention to treat
interleukin 2 was measured on days 2, 3, 7, 10 in peripheral blood mononuclear cells. The highest level on any of these days in each participant was chosen as the maximal level and used for the analysis.
Outcome measures
| Measure |
Echinacea
n=10 Participants
25 ml daily in 2 divided doses for 10 days
|
Placebo
n=10 Participants
25 ml daily in 2 divided doses for 10 days
|
|---|---|---|
|
Maximal Levels of Interleukin 2 (pg/ml)
|
287 interleukin 2 level (pg/ml)
Standard Deviation 244
|
829 interleukin 2 level (pg/ml)
Standard Deviation 1072
|
SECONDARY outcome
Timeframe: 10 daysPopulation: Intention to treat
interleukin 6 was measured on days 2, 3, 7, 10 in peripheral blood mononuclear cells. The highest level on any of these days in each participant was chosen as the maximal level and used for the analysis.
Outcome measures
| Measure |
Echinacea
n=10 Participants
25 ml daily in 2 divided doses for 10 days
|
Placebo
n=10 Participants
25 ml daily in 2 divided doses for 10 days
|
|---|---|---|
|
Maximal Levels of Interleukin 6 (pg/ml)
|
5085 interleukin 6 level (pg/ml)
Standard Deviation 375
|
2862 interleukin 6 level (pg/ml)
Standard Deviation 8761
|
SECONDARY outcome
Timeframe: 10 daysPopulation: Intention to treat
interleukin 12 was measured on days 2, 3, 7, 10 in peripheral blood mononuclear cells. The highest level on any of these days in each participant was chosen as the maximal level and used for the analysis.
Outcome measures
| Measure |
Echinacea
n=10 Participants
25 ml daily in 2 divided doses for 10 days
|
Placebo
n=10 Participants
25 ml daily in 2 divided doses for 10 days
|
|---|---|---|
|
Maximal Levels of Interleukin 12 (pg/ml)
|
13 interleukin 12 level (pg/ml)
Standard Deviation 17
|
6 interleukin 12 level (pg/ml)
Standard Deviation 19
|
Adverse Events
Echinacea
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Echinacea
n=10 participants at risk
25 ml daily in 2 divided doses for 10 days
|
Placebo
n=10 participants at risk
25 ml daily in 2 divided doses for 10 days
|
|---|---|---|
|
Eye disorders
blurred vision
|
10.0%
1/10 • 30 days
|
0.00%
0/10 • 30 days
|
|
Gastrointestinal disorders
constipation
|
10.0%
1/10 • 30 days
|
10.0%
1/10 • 30 days
|
|
Gastrointestinal disorders
diarrhea
|
0.00%
0/10 • 30 days
|
10.0%
1/10 • 30 days
|
|
Gastrointestinal disorders
gas/indigestion
|
10.0%
1/10 • 30 days
|
20.0%
2/10 • 30 days
|
|
Gastrointestinal disorders
nausea
|
40.0%
4/10 • 30 days
|
10.0%
1/10 • 30 days
|
|
Gastrointestinal disorders
taste: abnormal/metallic
|
10.0%
1/10 • 30 days
|
10.0%
1/10 • 30 days
|
|
Musculoskeletal and connective tissue disorders
musculoskeletal pain
|
0.00%
0/10 • 30 days
|
10.0%
1/10 • 30 days
|
|
General disorders
headache
|
0.00%
0/10 • 30 days
|
30.0%
3/10 • 30 days
|
|
Renal and urinary disorders
urinary: difficult/painful
|
0.00%
0/10 • 30 days
|
10.0%
1/10 • 30 days
|
|
General disorders
fever
|
10.0%
1/10 • 30 days
|
0.00%
0/10 • 30 days
|
|
Respiratory, thoracic and mediastinal disorders
sore throat
|
0.00%
0/10 • 30 days
|
10.0%
1/10 • 30 days
|
|
Respiratory, thoracic and mediastinal disorders
nasal congestion
|
10.0%
1/10 • 30 days
|
10.0%
1/10 • 30 days
|
|
Skin and subcutaneous tissue disorders
rash
|
10.0%
1/10 • 30 days
|
10.0%
1/10 • 30 days
|
|
Nervous system disorders
anxiety
|
10.0%
1/10 • 30 days
|
20.0%
2/10 • 30 days
|
|
General disorders
insomnia
|
0.00%
0/10 • 30 days
|
10.0%
1/10 • 30 days
|
|
General disorders
weakness/fatigue
|
10.0%
1/10 • 30 days
|
10.0%
1/10 • 30 days
|
|
General disorders
other
|
40.0%
4/10 • 30 days
|
20.0%
2/10 • 30 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place