Three Arm Trial of Immune Effects of Echinacea

Upper Respiratory Tract Infections Clinical Trial

Official title:

3-arm Randomized Controlled Trial Assessing the in Vivo Effect of an Echinacea Purpurea on Immune Markers in Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01129128
• Other study ID #: 10A1276
• Status: Completed
• Phase: N/A
• First received: May 14, 2010
• Last updated: June 14, 2012
• Start date: May 2010
• Est. completion date: March 2011

Study information

• Verified date: June 2012
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years to 65 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Respiratory Tract Infections
• Upper Respiratory Tract Infections

Intervention

Biological:
• Echinacea purpurea product
5 ml by mouth 3 times per day for 10 days
• Echinacea purpurea product
1 ml by mouth 3 times per day for 10 days
• Placebo
either 5 ml or 1 ml by mouth three times per day for 10 days

Locations

Country	Name	City	State
United States	Bastyr University	Kenmore	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peak Level of TNF Alpha	Highest level of TNF alpha while taking study medication	1-10 days after starting study medication	No
Secondary	Peak Level IL-6	Highest level of IL-6 while taking study medication	1-10 days after starting study medication	No
Secondary	Peak Level Interferon Gamma	Highest level of Interferon gamma while taking study medication	1-10 days after starting study medication	No
Secondary	Peak Level IL-2	Highest level of IL-2 while taking study medication	1-10 days after starting study medication	No
Secondary	Number of Participants With Adverse Events as a Measure of Safety and Tolerability	Adverse events such as nausea or rash in participants receiving an Echinacea formulation or placebo will be compared	1- 30 days after starting study medication	Yes