Three Arm Trial of Immune Effects of Echinacea

NCT01129128 | Completed Results

• 1 other identifier: 10A1276
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Upper Respiratory Tract Infections

Keywords

Echinacea; immune modulation; prevention

Outcome Measures

Primary Outcomes (1)

• Peak Level of TNF Alpha

  Highest level of TNF alpha while taking study medication

  1-10 days after starting study medication

Secondary Outcomes (4)

• Peak Level IL-6

  1-10 days after starting study medication

• Peak Level Interferon Gamma

  1-10 days after starting study medication

• Peak Level IL-2

  1-10 days after starting study medication

• Number of Participants With Adverse Events as a Measure of Safety and Tolerability

  1- 30 days after starting study medication

Study Arms (3)

Echinacea preparation 1

ACTIVE COMPARATOR

Commercially available Echinacea purpurea product

Biological: Echinacea purpurea product

Echinacea preparation 2

ACTIVE COMPARATOR

Commercially available Echinacea purpurea product

Biological: Echinacea purpurea product

Placebo

PLACEBO COMPARATOR

Inert liquid that is similar in appearance and taste to the active Echinacea products

Biological: Placebo

Interventions

Echinacea purpurea product BIOLOGICAL

5 ml by mouth 3 times per day for 10 days

Echinacea preparation 1

Placebo BIOLOGICAL

either 5 ml or 1 ml by mouth three times per day 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 adult (based on a screening health questionnaire)
• Speaks and reads English.
• If female of child-bearing potential, willing to use contraception to prevent pregnancy during the study.
• No use of any medication (other than multivitamins, essential fatty acids, oral contraceptives and probiotics) for 2 weeks prior to first dose of study.
• Willing to abstain from ingesting edible mushrooms for 2 weeks prior and throughout study.
• Willing to eat less than 2 garlic cloves per day for 2 weeks prior and during the study period

You may not qualify if:

• Pregnancy or currently breastfeeding.
• History of autoimmune disease or immune disorders.
• History of asthma.
• History of allergic rhinitis.
• History of physician diagnosed eczema, psoriasis or other skin condition that could mask an Echinacea-induced rash.
• Known allergic reaction to Echinacea or related species, specifically ragweed (Ambrosia), chamomile (Matricaria), goldenrod (Solidago), and sunflower (Helianthus).
• Known allergic reaction to xylitol sweetener, glycerine, citric acid, or citrus fruits

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

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases

Limitations and Caveats

Levels of TNF alpha, IL-6, IL-2 and Interferon gamma varied widely limiting chance of detecting differences.

Results Point of Contact

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

uncjat@uw.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: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 14, 2010
• First Posted: May 24, 2010
• Study Start: May 1, 2010
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: June 21, 2012
• Results First Posted: June 5, 2012

Record last verified: 2012-06

Locations

US (1)