N/A
N=20
Immunologic Effects of Echinacea
Upper Respiratory Tract Infections
Bottom Line
View on ClinicalTrials.gov: NCT00860795 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Nov 2010
Primary outcome: Primary: Maximal Level of Tumor Necrosis Factor Alpha (pg/ml) — 2694; 2648 tumor necrosis alpha level (pg/ml) — p=.17
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Echinacea purpurea (Biological); placebo (Drug)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- University of Washington
- Primary completion
- Aug 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximal Level of Tumor Necrosis Factor Alpha (pg/ml) |
2694; 2648 | .17 |
| SECONDARY Maximal Levels of Interferon Alpha (pg/ml) |
29; 35 | .72 |
| SECONDARY Maximal CD25/69 Activation (% of NK CD25/69+ Cells) |
1.07; 1.53 | .2 |
| SECONDARY Adverse Effects |
1; 1; 1; 1; 0; 1 | — |
| SECONDARY Maximal Levels of Interleukin 2 (pg/ml) |
287; 829 | .51 |
| SECONDARY Maximal Levels of Interleukin 6 (pg/ml) |
5085; 2862 | .43 |
| SECONDARY Maximal Levels of Interleukin 12 (pg/ml) |
13; 6 | .61 |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00860795). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.