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Study of the Immunologic Effects of Echinacea Purpurea in Adults


N/A
21 Years
65 Years
Not Enrolling
Both
Upper Respiratory Tract Infections

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Trial Information

Study of the Immunologic Effects of Echinacea Purpurea in Adults


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Outcome Measure:

Maximal Level of Tumor Necrosis Factor Alpha (pg/ml)

Outcome Description:

tumor necrosis factor alpha NK cells and evidence of CD25/69 activation

Outcome Time Frame:

10 days

Safety Issue:

No

Principal Investigator

James A Taylor, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Washington

Authority:

United States: Food and Drug Administration

Study ID:

09A1236

NCT ID:

NCT00860795

Start Date:

March 2009

Completion Date:

August 2009

Related Keywords:

  • Upper Respiratory Tract Infections
  • Echinacea
  • prevention
  • immune modulation
  • Respiratory Tract Infections

Name

Location
Bastyr University Kenmore, Washington