Immunologic Effects of Echinacea

NCT ID: NCT00860795

Last Updated: 2018-05-01

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2009-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Upper Respiratory Tract Infections

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Echinacea

Group Type ACTIVE_COMPARATOR

Echinacea purpurea

Intervention Type BIOLOGICAL

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

placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

placebo 25 ml daily in 2 divided doses for 10 days

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Echinacea purpurea

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

Intervention Type BIOLOGICAL

placebo

placebo 25 ml daily in 2 divided doses for 10 days

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

21 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role collaborator

University of Washington

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

James Taylor

School of Medicine: Pediatrics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

James A Taylor, MD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Bastyr University

Kenmore, Washington, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

5U01AT002400

Identifier Type: NIH

Identifier Source: secondary_id

View Link

09A1236

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

A Trial of Echinacea in Children
NCT00029211 COMPLETED PHASE3
Echinacea Safety Study
NCT01021995 COMPLETED PHASE4
Elderberry for Immune Support
NCT05435144 UNKNOWN NA