An interventional study of Echinacea purpurea and placebo in Upper Respiratory Tract Infections, sponsored by University of Washington. Completed at 1 site in United States. Open to participants aged 21 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-05-01.
Sponsored by University of Washington · Not applicable, Interventional, and Basic science
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.
1,031 studies on the registry are indexed under Respiratory Tract Infections; 144 are open to participants now.
This study's enrollment of 20 is below the median of 199 across 698 interventional studies indexed under Respiratory Tract Infections.
Browse Respiratory Tract Infections studies →University of Washington is the lead sponsor of 1,397 studies on the registry; 225 are open to participants now.
Of its 154 completed or terminated interventional studies of FDA-regulated products, 132 (86%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Biological: Echinacea purpurea
Drug: placebo
Echinacea purpurea 100 mg/ml, 25 ml daily in 2 divided doses for 10 days
placebo 25 ml daily in 2 divided doses for 10 days
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
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
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
Adverse Effects
Time frame: 30 days
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
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
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
Healthy adults were recruited using general advertising and enrolled between March and August 2009
| Milestone | Echinacea | Placebo |
|---|---|---|
| Started | 10 | 10 |
| Number to complete study medication | 9 | 10 |
| Completed | 10 | 10 |
| Not completed | 0 | 0 |
tumor necrosis factor alpha NK cells and evidence of CD25/69 activation
| tumor necrosis alpha level (pg/ml) | Echinacea | Placebo |
|---|---|---|
| Maximal Level of Tumor Necrosis Factor Alpha (pg/ml) | 2694 ± 1299 | 2648 ± 1625 |
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.
| interferon alpha level (pg/ml) | Echinacea | Placebo |
|---|---|---|
| Maximal Levels of Interferon Alpha (pg/ml) | 29 ± 47 | 35 ± 69 |
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
| (% of NK CD25/69+ cells) | Echinacea | Placebo |
|---|---|---|
| Maximal CD25/69 Activation (% of NK CD25/69+ Cells) | 1.07 ± .70 | 1.53 ± 1.10 |
| participants | Echinacea | Placebo |
|---|---|---|
| constipation | 1 | 1 |
| blurred vision | 1 | 1 |
| diarrhea | 0 | 1 |
| gas/indigestion | 1 | 2 |
| nausea | 4 | 1 |
| taste: abnormal/metallic | 1 | 1 |
| musculoskeletal pain | 0 | 1 |
| headache | 0 | 3 |
| fever | 1 | 0 |
| sore throat | 0 | 1 |
| nasal congestion | 1 | 1 |
| rash | 1 | 1 |
| anxiety | 1 | 2 |
| insomnia | 0 | 1 |
| weakness/fatigue | 1 | 1 |
| urinary: difficult/painful | 0 | 1 |
| other | 4 | 2 |
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.
| interleukin 2 level (pg/ml) | Echinacea | Placebo |
|---|---|---|
| Maximal Levels of Interleukin 2 (pg/ml) | 287 ± 244 | 829 ± 1072 |
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.
| interleukin 6 level (pg/ml) | Echinacea | Placebo |
|---|---|---|
| Maximal Levels of Interleukin 6 (pg/ml) | 5085 ± 375 | 2862 ± 8761 |
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.
| interleukin 12 level (pg/ml) | Echinacea | Placebo |
|---|---|---|
| Maximal Levels of Interleukin 12 (pg/ml) | 13 ± 17 | 6 ± 19 |
Collected over 30 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Echinacea | — | 0/10 (0%) | 6/10 (60%) |
| Placebo | — | 0/10 (0%) | 7/10 (70%) |
| Event | Echinacea | Placebo |
|---|---|---|
| nauseaGastrointestinal disorders | 4/10 | 1/10 |
| otherGeneral disorders | 4/10 | 2/10 |
| headacheGeneral disorders | 0/10 | 3/10 |
| gas/indigestionGastrointestinal disorders | 1/10 | 2/10 |
| anxietyNervous system disorders | 1/10 | 2/10 |
| blurred visionEye disorders | 1/10 | 0/10 |
| constipationGastrointestinal disorders | 1/10 | 1/10 |
| diarrheaGastrointestinal disorders | 0/10 | 1/10 |
| taste: abnormal/metallicGastrointestinal disorders | 1/10 | 1/10 |
| musculoskeletal painMusculoskeletal and connective tissue disorders | 0/10 | 1/10 |
| Age, Categorical(Participants) | Echinacea | Placebo | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 10 | 10 | 20 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Echinacea | Placebo | Total |
|---|---|---|---|
| Mean | 35.5 ± 12.6 | 37.4 ± 14.3 | 36.5 ± 13.2 |
| Sex: Female, Male(Participants) | Echinacea | Placebo | Total |
|---|---|---|---|
| Female | 8 | 6 | 14 |
| Male | 2 | 4 | 6 |
| Region of Enrollment(participants) | Echinacea | Placebo | Total |
|---|---|---|---|
| United States | 10 | 10 | 20 |
This study is completed, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.
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