Upper Respiratory Tract Infections
Conditions
Keywords
Echinacea, prevention, immune modulation
Brief summary
The goal of this study is to determine if Echinacea purpurea stimulates the immune system. For the study, 20 healthy adults will be randomized to receive Echinacea purpurea or placebo for 10 days. Blood will be drawn to assess immune markers just before beginning the study medication, during the 10 day course of medication and after completing the course of medication. It is postulated that adults receiving the Echinacea will have evidence of immune stimulation and those receiving placebo will not.
Interventions
BIOLOGICALEchinacea purpurea
Echinacea purpurea 100 mg/ml, 25 ml daily in 2 divided doses for 10 days
DRUGplacebo
placebo 25 ml daily in 2 divided doses for 10 days
Sponsors
National Center for Complementary and Integrative Health (NCCIH)
University of Washington
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy adults 21-65 years old * If female of child-bearing potential, willing to use contraception to prevent pregnancy * Speaks and reads English * No use of any medication (other than multivitamins, essential fatty acids or probiotics) * Willing to abstain from ingesting edible mushrooms throughout study * Willing to eat less than 2 garlic cloves per day throughout study
Exclusion criteria
* Positive pregnancy test or currently breastfeeding * History of autoimmune disease * History of allergic rhinitis * History of physician diagnosed eczema * Known allergic reaction to Echinacea or related species, specifically ragweed (Ambrosia), chamomile (Matricaria), goldenrod (Solidago) and sunflower (Helianthus) * Use of any medication within 30 days prior to first dose of study medication that is a known inhibitor or inducer of CYP34A
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximal Level of Tumor Necrosis Factor Alpha (pg/ml) | 10 days | tumor necrosis factor alpha NK cells and evidence of CD25/69 activation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maximal CD25/69 Activation (% of NK CD25/69+ Cells) | 10 days | 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 |
| Adverse Effects | 30 days | — |
| Maximal Levels of Interferon Alpha (pg/ml) | 10 days | 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. |
| Maximal Levels of Interleukin 6 (pg/ml) | 10 days | 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. |
| Maximal Levels of Interleukin 12 (pg/ml) | 10 days | 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. |
| Maximal Levels of Interleukin 2 (pg/ml) | 10 days | 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. |
Countries
United States
Participant flow
Recruitment details
Healthy adults were recruited using general advertising and enrolled between March and August 2009
Participants by arm
| Arm | Count |
|---|---|
| Echinacea 25 ml daily in 2 divided doses for 10 days | 10 |
| Placebo 25 ml daily in 2 divided doses for 10 days | 10 |
| Total | 20 |
Baseline characteristics
| Characteristic | Placebo | Echinacea | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants | 10 Participants | 20 Participants |
| Age, Continuous | 37.4 years STANDARD_DEVIATION 14.3 | 35.5 years STANDARD_DEVIATION 12.6 | 36.5 years STANDARD_DEVIATION 13.2 |
| Region of Enrollment United States | 10 participants | 10 participants | 20 participants |
| Sex: Female, Male Female | 6 Participants | 8 Participants | 14 Participants |
| Sex: Female, Male Male | 4 Participants | 2 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 6 / 10 | 7 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 |
Outcome results
Primary
Maximal Level of Tumor Necrosis Factor Alpha (pg/ml)
tumor necrosis factor alpha NK cells and evidence of CD25/69 activation
Time frame: 10 days
Population: Intention to treat
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Echinacea | Maximal Level of Tumor Necrosis Factor Alpha (pg/ml) | 2694 tumor necrosis alpha level (pg/ml) | Standard Deviation 1299 |
| Placebo | Maximal Level of Tumor Necrosis Factor Alpha (pg/ml) | 2648 tumor necrosis alpha level (pg/ml) | Standard Deviation 1625 |
p-value: 0.17Regression, Linear
Secondary
Adverse Effects
Time frame: 30 days
Population: intention to treat
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Echinacea | Adverse Effects | insomnia | 0 participants |
| Echinacea | Adverse Effects | sore throat | 0 participants |
| Echinacea | Adverse Effects | weakness/fatigue | 1 participants |
| Echinacea | Adverse Effects | urinary: difficult/painful | 0 participants |
| Echinacea | Adverse Effects | other | 4 participants |
| Echinacea | Adverse Effects | constipation | 1 participants |
| Echinacea | Adverse Effects | blurred vision | 1 participants |
| Echinacea | Adverse Effects | diarrhea | 0 participants |
| Echinacea | Adverse Effects | gas/indigestion | 1 participants |
| Echinacea | Adverse Effects | nausea | 4 participants |
| Echinacea | Adverse Effects | taste: abnormal/metallic | 1 participants |
| Echinacea | Adverse Effects | musculoskeletal pain | 0 participants |
| Echinacea | Adverse Effects | headache | 0 participants |
| Echinacea | Adverse Effects | fever | 1 participants |
| Echinacea | Adverse Effects | nasal congestion | 1 participants |
| Echinacea | Adverse Effects | rash | 1 participants |
| Echinacea | Adverse Effects | anxiety | 1 participants |
| Placebo | Adverse Effects | fever | 0 participants |
| Placebo | Adverse Effects | insomnia | 1 participants |
| Placebo | Adverse Effects | nausea | 1 participants |
| Placebo | Adverse Effects | sore throat | 1 participants |
| Placebo | Adverse Effects | weakness/fatigue | 1 participants |
| Placebo | Adverse Effects | taste: abnormal/metallic | 1 participants |
| Placebo | Adverse Effects | urinary: difficult/painful | 1 participants |
| Placebo | Adverse Effects | rash | 1 participants |
| Placebo | Adverse Effects | other | 2 participants |
| Placebo | Adverse Effects | musculoskeletal pain | 1 participants |
| Placebo | Adverse Effects | constipation | 1 participants |
| Placebo | Adverse Effects | nasal congestion | 1 participants |
| Placebo | Adverse Effects | blurred vision | 1 participants |
| Placebo | Adverse Effects | headache | 3 participants |
| Placebo | Adverse Effects | diarrhea | 1 participants |
| Placebo | Adverse Effects | anxiety | 2 participants |
| Placebo | Adverse Effects | gas/indigestion | 2 participants |
Secondary
Maximal CD25/69 Activation (% of NK CD25/69+ Cells)
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
Time frame: 10 days
Population: intention to treat
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Echinacea | Maximal CD25/69 Activation (% of NK CD25/69+ Cells) | 1.07 (% of NK CD25/69+ cells) | Standard Deviation 0.7 |
| Placebo | Maximal CD25/69 Activation (% of NK CD25/69+ Cells) | 1.53 (% of NK CD25/69+ cells) | Standard Deviation 1.1 |
p-value: 0.2Regression, Linear
Secondary
Maximal Levels of Interferon Alpha (pg/ml)
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.
Time frame: 10 days
Population: Intention to treat
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Echinacea | Maximal Levels of Interferon Alpha (pg/ml) | 29 interferon alpha level (pg/ml) | Standard Deviation 47 |
| Placebo | Maximal Levels of Interferon Alpha (pg/ml) | 35 interferon alpha level (pg/ml) | Standard Deviation 69 |
p-value: 0.72Regression, Linear
Secondary
Maximal Levels of Interleukin 12 (pg/ml)
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.
Time frame: 10 days
Population: Intention to treat
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Echinacea | Maximal Levels of Interleukin 12 (pg/ml) | 13 interleukin 12 level (pg/ml) | Standard Deviation 17 |
| Placebo | Maximal Levels of Interleukin 12 (pg/ml) | 6 interleukin 12 level (pg/ml) | Standard Deviation 19 |
p-value: 0.61Regression, Linear
Secondary
Maximal Levels of Interleukin 2 (pg/ml)
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.
Time frame: 10 days
Population: intention to treat
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Echinacea | Maximal Levels of Interleukin 2 (pg/ml) | 287 interleukin 2 level (pg/ml) | Standard Deviation 244 |
| Placebo | Maximal Levels of Interleukin 2 (pg/ml) | 829 interleukin 2 level (pg/ml) | Standard Deviation 1072 |
p-value: 0.51Regression, Linear
Secondary
Maximal Levels of Interleukin 6 (pg/ml)
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.
Time frame: 10 days
Population: Intention to treat
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Echinacea | Maximal Levels of Interleukin 6 (pg/ml) | 5085 interleukin 6 level (pg/ml) | Standard Deviation 375 |
| Placebo | Maximal Levels of Interleukin 6 (pg/ml) | 2862 interleukin 6 level (pg/ml) | Standard Deviation 8761 |
p-value: 0.43Regression, Linear