Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 5U01AT002400 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Echinacea | Active Comparator |
| |
| placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Echinacea purpurea | Biological | Echinacea purpurea 100 mg/ml, 25 ml daily in 2 divided doses for 10 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximal Level of Tumor Necrosis Factor Alpha (pg/ml) | tumor necrosis factor alpha NK cells and evidence of CD25/69 activation | 10 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 10 days |
| Maximal CD25/69 Activation (% of NK CD25/69+ Cells) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| James A Taylor, MD | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bastyr University | Kenmore | Washington | 98028 | United States |
Not provided
Healthy adults were recruited using general advertising and enrolled between March and August 2009
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Echinacea | 25 ml daily in 2 divided doses for 10 days |
| FG001 | Placebo | 25 ml daily in 2 divided doses for 10 days |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Echinacea | 25 ml daily in 2 divided doses for 10 days |
| BG001 | Placebo | 25 ml daily in 2 divided doses for 10 days |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Maximal Level of Tumor Necrosis Factor Alpha (pg/ml) | tumor necrosis factor alpha NK cells and evidence of CD25/69 activation | Intention to treat | Posted | Mean | Standard Deviation | tumor necrosis alpha level (pg/ml) | 10 days |
|
|
30 days
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Echinacea | 25 ml daily in 2 divided doses for 10 days |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| blurred vision | Eye disorders | MOSES | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| James A Taylor, MD | University of Washington | 206-616-1206 | uncjat@u.washington.edu |
Not provided
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| ID | Term |
|---|---|
| D007239 | Infections |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000718679 | Echinacea extract |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| placebo | Drug | placebo 25 ml daily in 2 divided doses for 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 |
| 10 days |
| Adverse Effects | 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. | 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. | 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. | 10 days |
| BG002 |
| Total |
Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
|
|
| 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. | Intention to treat | Posted | Mean | Standard Deviation | interferon alpha level (pg/ml) | 10 days |
|
|
|
|
| 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 | intention to treat | Posted | Mean | Standard Deviation | (% of NK CD25/69+ cells) | 10 days |
|
|
|
|
| Secondary | Adverse Effects | intention to treat | Posted | Number | participants | 30 days | participants | participants |
|
|
|
| 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. | intention to treat | Posted | Mean | Standard Deviation | interleukin 2 level (pg/ml) | 10 days |
|
|
|
|
| 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. | Intention to treat | Posted | Mean | Standard Deviation | interleukin 6 level (pg/ml) | 10 days |
|
|
|
|
| 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. | Intention to treat | Posted | Mean | Standard Deviation | interleukin 12 level (pg/ml) | 10 days |
|
|
|
|
| 0 |
| 10 |
| 6 |
| 10 |
| EG001 | Placebo | 25 ml daily in 2 divided doses for 10 days | 0 | 10 | 7 | 10 |
| constipation | Gastrointestinal disorders | MOSES | Systematic Assessment |
|
| diarrhea | Gastrointestinal disorders | MOSES | Systematic Assessment |
|
| gas/indigestion | Gastrointestinal disorders | MOSES | Systematic Assessment |
|
| nausea | Gastrointestinal disorders | MOSES | Systematic Assessment |
|
| taste: abnormal/metallic | Gastrointestinal disorders | MOSES | Systematic Assessment |
|
| musculoskeletal pain | Musculoskeletal and connective tissue disorders | MOSES | Systematic Assessment |
|
| headache | General disorders | MOSES | Systematic Assessment |
|
| urinary: difficult/painful | Renal and urinary disorders | MOSES | Systematic Assessment |
|
| fever | General disorders | MOSES | Systematic Assessment |
|
| sore throat | Respiratory, thoracic and mediastinal disorders | MOSES | Systematic Assessment |
|
| nasal congestion | Respiratory, thoracic and mediastinal disorders | MOSES | Systematic Assessment |
|
| rash | Skin and subcutaneous tissue disorders | MOSES | Systematic Assessment |
|
| anxiety | Nervous system disorders | MOSES | Systematic Assessment |
|
| insomnia | General disorders | MOSES | Systematic Assessment |
|
| weakness/fatigue | General disorders | MOSES | Systematic Assessment |
|
| other | General disorders | MOSES | Systematic Assessment | tongue tingling, tongue numbness, lip numbness reported by 3 participants taking Echinacea |
|
Not provided
Not provided
| diarrhea |
|
| gas/indigestion |
|
| nausea |
|
| taste: abnormal/metallic |
|
| musculoskeletal pain |
|
| headache |
|
| fever |
|
| sore throat |
|
| nasal congestion |
|
| rash |
|
| anxiety |
|
| insomnia |
|
| weakness/fatigue |
|
| urinary: difficult/painful |
|
| other |
|