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| Name | Class |
|---|---|
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Echinacea preparation 1 | Active Comparator | Commercially available Echinacea purpurea product |
|
| Echinacea preparation 2 | Active Comparator | Commercially available Echinacea purpurea product |
|
| Placebo | Placebo Comparator | Inert liquid that is similar in appearance and taste to the active Echinacea products |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Echinacea purpurea product | Biological | 5 ml by mouth 3 times per day for 10 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Peak Level of TNF Alpha | Highest level of TNF alpha while taking study medication | 1-10 days after starting study medication |
| Measure | Description | Time Frame |
|---|---|---|
| Peak Level IL-6 | Highest level of IL-6 while taking study medication | 1-10 days after starting study medication |
| Peak Level Interferon Gamma | Highest level of Interferon gamma while taking study medication |
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Inclusion Criteria:
Exclusion Criteria:
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| 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 |
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Healthy adult volunteers enrolled from May 2010 through March 2011
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| ID | Title | Description |
|---|---|---|
| FG000 | Commercially Available Echinacea Product #1 (5 ml/Dose) | Echinacea purpurea product; 5 ml dose administered three times daily for 10 days |
| FG001 | Commercially Available Echinacea Product #2 (1 ml/Dose) | Echinacea purpurea product; 1 ml dose administered three times daily for 10 days |
| FG002 | Placebo | Inert liquid that is similar in appearance and taste to the active Echinacea products |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Commercially Available Echinacea Product #1 (5 ml/Dose) | Echinacea purpurea product; 5 ml dose administered three times daily for 10 days |
| BG001 | Commercially Available Echinacea Product #2 (1 ml/Dose) |
| 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 | Peak Level of TNF Alpha | Highest level of TNF alpha while taking study medication | Data analyzed on any participant who TNF alpha level was obtained on 1 or more days while on study medication. | Posted | Mean | Standard Deviation | pg/ml | 1-10 days after starting study medication |
|
day 1 (first dose of study medication) through day 30
Patients specifically inquired about adverse events on day 2, 3, 7, 10, 17 and 30 using 76-item questionnaire.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Commercially Available Echinacea Product #1 (5 ml/Dose) | Echinacea purpurea product; 5 ml dose administered three times daily for 10 days |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain/cramps | Gastrointestinal disorders | MOSES | Systematic Assessment |
Levels of TNF alpha, IL-6, IL-2 and Interferon gamma varied widely limiting chance of detecting differences.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| James A Taylor, MD | University of Washington | 206-616-1206 | uncjat@uw.edu |
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| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| ID | Term |
|---|---|
| D007239 | Infections |
| D012140 | Respiratory Tract Diseases |
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| Echinacea purpurea product | Biological | 1 ml by mouth 3 times per day for 10 days |
|
| Placebo | Biological | either 5 ml or 1 ml by mouth three times per day for 10 days |
|
| 1-10 days after starting study medication |
| Peak Level IL-2 | Highest level of IL-2 while taking study medication | 1-10 days after starting study medication |
| 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 | 1- 30 days after starting study medication |
| Withdrawal by Subject |
|
| Physician Decision |
|
Echinacea purpurea product; 1 ml dose administered three times daily for 10 days
| BG002 | Placebo | Inert liquid that is similar in appearance and taste to the active Echinacea products |
| BG003 | 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 |
|
| OG002 | Placebo | Inert liquid that is similar in appearance and taste to the active Echinacea products |
|
|
|
| Secondary | Peak Level IL-6 | Highest level of IL-6 while taking study medication | Data analyzed on any participant who IL-6 level was obtained on 1 or more days while on study medication. | Posted | Mean | Standard Deviation | pg/ml | 1-10 days after starting study medication |
|
|
|
|
| Secondary | Peak Level Interferon Gamma | Highest level of Interferon gamma while taking study medication | Data analyzed on any participant who Interferon gamma level was obtained on 1 or more days while on study medication. | Posted | Mean | Standard Deviation | pg/ml | 1-10 days after starting study medication |
|
|
|
|
| Secondary | Peak Level IL-2 | Highest level of IL-2 while taking study medication | Data analyzed on any participant who IL-2 level was obtained on 1 or more days while on study medication. | Posted | Mean | Standard Deviation | pg/ml | 1-10 days after starting study medication |
|
|
|
|
| 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 | Participants who received at least one dose of study medication | Posted | Number | participants | 1- 30 days after starting study medication |
|
|
|
| 0 |
| 22 |
| 14 |
| 22 |
| EG001 | Commercially Available Echinacea Product #2 (1 ml/Dose) | Echinacea purpurea product; 1 ml dose administered three times daily for 10 days | 0 | 22 | 18 | 22 |
| EG002 | Placebo | Inert liquid that is similar in appearance and taste to the active Echinacea products | 0 | 22 | 16 | 22 |
| Appetite: decreased | Gastrointestinal disorders | MOSES | Systematic Assessment |
|
| Appetite: increased | Gastrointestinal disorders | MOSES | Systematic Assessment |
|
| constipation | Gastrointestinal disorders | MOSES | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | MOSES | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MOSES | Systematic Assessment |
|
| Gas/indigestion | Gastrointestinal disorders | MOSES | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MOSES | Systematic Assessment |
|
| Thirst: increased | Metabolism and nutrition disorders | MOSES | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MOSES | Systematic Assessment |
|
| Headache | Nervous system disorders | MOSES | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MOSES | Systematic Assessment |
|
| Depression | Psychiatric disorders | MOSES | Systematic Assessment |
|
| Drowsiness/sedation | General disorders | MOSES | Systematic Assessment |
|
| Sleep: excessive | General disorders | MOSES | Systematic Assessment |
|
| Sleep: insomnia, restless | General disorders | MOSES | Systematic Assessment |
|
| Weakness/fatigue | General disorders | MOSES | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MOSES | Systematic Assessment |
|
| Rash/hives | Skin and subcutaneous tissue disorders | MOSES | Systematic Assessment |
|
| Sore throat | Respiratory, thoracic and mediastinal disorders | MOSES | Systematic Assessment |
|
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controlled for baseline levels and performed log transformation of IL-6 levels to account for skewed distribution of values |
| 0.68 |
| Mean Difference (Final Values) |
| 23472 |
| 95 |
| No |
| Superiority or Other |
controlled for baseline levels and performed log transformation of Interferon gamma levels to account for skewed distribution of values |
| 0.76 |
| Mean Difference (Final Values) |
| -12 |
| 95 |
| No |
| Superiority or Other |
controlled for baseline levels
| 0.34 |
| Mean Difference (Final Values) |
| 39 |
| 95 |
| No |
| Superiority or Other |