Trial record 4 of 8 for:    Echinacea | NCCAM

Three Arm Trial of Immune Effects of Echinacea

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
James Taylor, University of Washington
ClinicalTrials.gov Identifier:
NCT01129128
First received: May 14, 2010
Last updated: June 14, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention
Upper Respiratory Tract Infections
Biological: Echinacea purpurea product
Biological: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Basic Science
Official Title: 3-arm Randomized Controlled Trial Assessing the in Vivo Effect of an Echinacea Purpurea on Immune Markers in Adults

Resource links provided by NLM:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • Peak Level of TNF Alpha [ Time Frame: 1-10 days after starting study medication ] [ Designated as safety issue: No ]
    Highest level of TNF alpha while taking study medication


Secondary Outcome Measures:
  • Peak Level IL-6 [ Time Frame: 1-10 days after starting study medication ] [ Designated as safety issue: No ]
    Highest level of IL-6 while taking study medication

  • Peak Level Interferon Gamma [ Time Frame: 1-10 days after starting study medication ] [ Designated as safety issue: No ]
    Highest level of Interferon gamma while taking study medication

  • Peak Level IL-2 [ Time Frame: 1-10 days after starting study medication ] [ Designated as safety issue: No ]
    Highest level of IL-2 while taking study medication

  • Number of Participants With Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 1- 30 days after starting study medication ] [ Designated as safety issue: Yes ]
    Adverse events such as nausea or rash in participants receiving an Echinacea formulation or placebo will be compared


Enrollment: 67
Study Start Date: May 2010
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Echinacea preparation 1
Commercially available Echinacea purpurea product
Biological: Echinacea purpurea product
5 ml by mouth 3 times per day for 10 days
Active Comparator: Echinacea preparation 2
Commercially available Echinacea purpurea product
Biological: Echinacea purpurea product
1 ml by mouth 3 times per day for 10 days
Placebo Comparator: Placebo
Inert liquid that is similar in appearance and taste to the active Echinacea products
Biological: Placebo
either 5 ml or 1 ml by mouth three times per day for 10 days

  Eligibility

Ages Eligible for Study:   21 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01129128

Locations
United States, Washington
Bastyr University
Kenmore, Washington, United States, 98028
Sponsors and Collaborators
University of Washington
Investigators
Principal Investigator: James A Taylor, MD University of Washington
  More Information

No publications provided

Responsible Party: James Taylor, Professor, University of Washington
ClinicalTrials.gov Identifier: NCT01129128     History of Changes
Other Study ID Numbers: 10A1276
Study First Received: May 14, 2010
Results First Received: May 4, 2012
Last Updated: June 14, 2012
Health Authority: United States: Federal Government

Keywords provided by University of Washington:
Echinacea
immune modulation
prevention

Additional relevant MeSH terms:
Respiratory Tract Infections
Infection
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 16, 2014