Upper Respiratory Tract Infections
Conditions
Keywords
Echinacea, immune modulation, prevention
Brief summary
The goal of this study is to determine if either of two, commercially available, Echinacea purpurea products stimulate the immune system. For the study, 60 healthy adults will be randomized to receive one of the two Echinacea purpurea products 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 either of the Echinacea products will have evidence of immune stimulation and those receiving placebo will not.
Interventions
BIOLOGICALEchinacea purpurea product
5 ml by mouth 3 times per day for 10 days
BIOLOGICALPlacebo
either 5 ml or 1 ml by mouth three times per day 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
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy adult (based on a screening health questionnaire) * Speaks and reads English. * If female of child-bearing potential, willing to use contraception to prevent pregnancy during the study. * No use of any medication (other than multivitamins, essential fatty acids, oral contraceptives and probiotics) for 2 weeks prior to first dose of study. * Willing to abstain from ingesting edible mushrooms for 2 weeks prior and throughout study. * Willing to eat less than 2 garlic cloves per day for 2 weeks prior and during the study period
Exclusion criteria
* Pregnancy or currently breastfeeding. * History of autoimmune disease or immune disorders. * History of asthma. * History of allergic rhinitis. * History of physician diagnosed eczema, psoriasis or other skin condition that could mask an Echinacea-induced rash. * Known allergic reaction to Echinacea or related species, specifically ragweed (Ambrosia), chamomile (Matricaria), goldenrod (Solidago), and sunflower (Helianthus). * Known allergic reaction to xylitol sweetener, glycerine, citric acid, or citrus fruits
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Peak Level of TNF Alpha | 1-10 days after starting study medication | Highest level of TNF alpha while taking study medication |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Peak Level IL-6 | 1-10 days after starting study medication | Highest level of IL-6 while taking study medication |
| Peak Level Interferon Gamma | 1-10 days after starting study medication | Highest level of Interferon gamma while taking study medication |
| Peak Level IL-2 | 1-10 days after starting study medication | Highest level of IL-2 while taking study medication |
| Number of Participants With Adverse Events as a Measure of Safety and Tolerability | 1- 30 days after starting study medication | Adverse events such as nausea or rash in participants receiving an Echinacea formulation or placebo will be compared |
Countries
United States
Participant flow
Recruitment details
Healthy adult volunteers enrolled from May 2010 through March 2011
Participants by arm
| Arm | Count |
|---|---|
| Commercially Available Echinacea Product #1 (5 ml/Dose) Echinacea purpurea product; 5 ml dose administered three times daily for 10 days | 22 |
| Commercially Available Echinacea Product #2 (1 ml/Dose) Echinacea purpurea product; 1 ml dose administered three times daily for 10 days | 22 |
| Placebo Inert liquid that is similar in appearance and taste to the active Echinacea products | 23 |
| Total | 67 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 2 | 1 |
| Overall Study | Physician Decision | 1 | 0 | 0 |
| Overall Study | Protocol Violation | 0 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 1 | 3 |
Baseline characteristics
| Characteristic | Total | Commercially Available Echinacea Product #1 (5 ml/Dose) | Commercially Available Echinacea Product #2 (1 ml/Dose) | Placebo |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 67 Participants | 22 Participants | 22 Participants | 23 Participants |
| Age Continuous | 32.4 years STANDARD_DEVIATION 13.1 | 34.1 years STANDARD_DEVIATION 10.6 | 35.1 years STANDARD_DEVIATION 13.5 | 28.2 years STANDARD_DEVIATION 8 |
| Region of Enrollment United States | 67 participants | 22 participants | 22 participants | 23 participants |
| Sex: Female, Male Female | 47 Participants | 16 Participants | 14 Participants | 17 Participants |
| Sex: Female, Male Male | 20 Participants | 6 Participants | 8 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 14 / 22 | 18 / 22 | 16 / 22 |
| serious Total, serious adverse events | 0 / 22 | 0 / 22 | 0 / 22 |
Outcome results
Primary
Peak Level of TNF Alpha
Highest level of TNF alpha while taking study medication
Time frame: 1-10 days after starting study medication
Population: Data analyzed on any participant who TNF alpha level was obtained on 1 or more days while on study medication.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Commercially Available Echinacea Product #1 (5 ml/Dose) | Peak Level of TNF Alpha | 436 pg/ml | Standard Deviation 510 |
| Commercially Available Echinacea Product #2 (1 ml/Dose) | Peak Level of TNF Alpha | 1467 pg/ml | Standard Deviation 2330 |
| Placebo | Peak Level of TNF Alpha | 721 pg/ml | Standard Deviation 1272 |
Comparison: comparison of peak level of TNF alpha after controlling for baseline level. Based on data from 20 participants in a group, there was a power of 0.9 to detect a difference of 1000 pg/ml with a standard deviation of 700 pg/mlp-value: 0.87Regression, Linear
Comparison: comparison of peak level of TNF alpha after controlling for baseline level. Based on data from 20 participants in a group, there was a power of .9 to detect a difference of 1000 pg/ml with a standard deviation of 700 pg/mlp-value: 0.82Regression, Linear
Secondary
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Adverse events such as nausea or rash in participants receiving an Echinacea formulation or placebo will be compared
Time frame: 1- 30 days after starting study medication
Population: Participants who received at least one dose of study medication
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Commercially Available Echinacea Product #1 (5 ml/Dose) | Number of Participants With Adverse Events as a Measure of Safety and Tolerability | 14 participants |
| Commercially Available Echinacea Product #2 (1 ml/Dose) | Number of Participants With Adverse Events as a Measure of Safety and Tolerability | 18 participants |
| Placebo | Number of Participants With Adverse Events as a Measure of Safety and Tolerability | 16 participants |
Secondary
Peak Level IL-2
Highest level of IL-2 while taking study medication
Time frame: 1-10 days after starting study medication
Population: Data analyzed on any participant who IL-2 level was obtained on 1 or more days while on study medication.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Commercially Available Echinacea Product #1 (5 ml/Dose) | Peak Level IL-2 | 82 pg/ml | Standard Deviation 79 |
| Commercially Available Echinacea Product #2 (1 ml/Dose) | Peak Level IL-2 | 148 pg/ml | Standard Deviation 321 |
| Placebo | Peak Level IL-2 | 68 pg/ml | Standard Deviation 64 |
p-value: 0.98Regression, Linear
p-value: 0.34Regression, Linear
Secondary
Peak Level IL-6
Highest level of IL-6 while taking study medication
Time frame: 1-10 days after starting study medication
Population: Data analyzed on any participant who IL-6 level was obtained on 1 or more days while on study medication.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Commercially Available Echinacea Product #1 (5 ml/Dose) | Peak Level IL-6 | 16296 pg/ml | Standard Deviation 37448 |
| Commercially Available Echinacea Product #2 (1 ml/Dose) | Peak Level IL-6 | 44901 pg/ml | Standard Deviation 79868 |
| Placebo | Peak Level IL-6 | 28526 pg/ml | Standard Deviation 61921 |
p-value: 0.82Regression, Linear
p-value: 0.68Regression, Linear
Secondary
Peak Level Interferon Gamma
Highest level of Interferon gamma while taking study medication
Time frame: 1-10 days after starting study medication
Population: Data analyzed on any participant who Interferon gamma level was obtained on 1 or more days while on study medication.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Commercially Available Echinacea Product #1 (5 ml/Dose) | Peak Level Interferon Gamma | 74 pg/ml | Standard Deviation 122 |
| Commercially Available Echinacea Product #2 (1 ml/Dose) | Peak Level Interferon Gamma | 146 pg/ml | Standard Deviation 321 |
| Placebo | Peak Level Interferon Gamma | 121 pg/ml | Standard Deviation 292 |
p-value: 0.9Regression, Linear
p-value: 0.76Regression, Linear