Immunologic Effects of Echinacea

NCT00860795 | Completed Results DMC

• 2 other identifiers: 09A12365U01AT002400
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Upper Respiratory Tract Infections

Keywords

Echinacea; prevention; immune modulation

Outcome Measures

Primary Outcomes (1)

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

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

  10 days

Secondary Outcomes (6)

• Maximal Levels of Interferon Alpha (pg/ml)

  10 days

• Maximal CD25/69 Activation (% of NK CD25/69+ Cells)

  10 days

• Adverse Effects

  30 days

• Maximal Levels of Interleukin 2 (pg/ml)

  10 days

• Maximal Levels of Interleukin 6 (pg/ml)

  10 days

Study Arms (2)

Echinacea

ACTIVE COMPARATOR

Biological: Echinacea purpurea

placebo

PLACEBO COMPARATOR

Drug: placebo

Interventions

Echinacea purpurea BIOLOGICAL

Echinacea purpurea 100 mg/ml, 25 ml daily in 2 divided doses for 10 days

Echinacea

placebo DRUG

placebo 25 ml daily in 2 divided doses for 10 days

placebo

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Washington: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

Bastyr University

Kenmore, Washington, 98028, United States

Location

MeSH Terms

Conditions

Respiratory Tract Infections

Interventions

Echinacea extract

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases

Results Point of Contact

• Title: James A Taylor, MD
• Organization: University of Washington

uncjat@u.washington.edu

206-616-1206

Study Officials

• James A Taylor, MD

  University of Washington

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: School of Medicine: Pediatrics

Study Record Dates

• First Submitted: March 10, 2009
• First Posted: March 12, 2009
• Study Start: March 1, 2009
• Primary Completion: August 1, 2009
• Study Completion: August 1, 2009
• Last Updated: May 1, 2018
• Results First Posted: November 17, 2010

Record last verified: 2018-04

Locations

US (1)