Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01129128
Other study ID # 10A1276
Secondary ID
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


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
See also
  Status Clinical Trial Phase
Completed NCT01158560 - A Trial of Vitamin D and Health Advice for the Prevention of Upper Respiratory Tract Infections Phase 3
Completed NCT00965822 - A Randomized, Double-blind, Placebo-controlled Study on the Efficacy and Safety of CVT-E002 in the Treatment of Upper Respiratory Tract Infections in a Pediatric (3-11 Years) Population Phase 2
Completed NCT01019889 - Effect of Socheongryong-tang and Yeongyopaedok-san in Upper Respiratory Tract Infection Phase 3
Not yet recruiting NCT05484102 - Preventive Effect of Cow's Milk Fermented With Lactobacillus Paracasei CBA L74 on Common Infectious Diseases in Children N/A
Recruiting NCT05804123 - LiveSpo Navax® Supports the Treatment of Acute Rhinosinusitis and Otitis Media N/A
Terminated NCT01964885 - Benefit and Tolerability of IQP-AS-105 in Reducing Susceptibility to Upper Respiratory Tract Infections Phase 3
Completed NCT01773824 - Routine Prescription Feedback and Peer Comparison to Lower Antibiotic Prescriptions in Primary Care N/A
Completed NCT01883427 - Nasal Spray With Glucose Oxidase Preventing Common Cold in Pre-school Children Phase 2
Completed NCT01215682 - Vitamin D Supplementation and Upper Respiratory Tract Infections in Adolescent Swimmers N/A
Completed NCT04019730 - The Effect of a Ketogenic Diet on the Exercise Induced Immune Response N/A
Completed NCT01604096 - Controlled Trial to Evaluate a Local Information Campaign on Antibiotic Prescribing in Italy Phase 2
Recruiting NCT06149494 - RCT of Vapendavir in Patients With COPD and Human Rhinovirus/Enterovirus Upper Respiratory Infection Phase 2
Completed NCT03463694 - Edinburgh and Lothian Virus Intervention Study in Kids N/A
Completed NCT06127186 - Phenotype of Headache and Facial Pain in Upper Respiratory Tract Infections
Completed NCT03198676 - A Safety Study to Compare the Effect of Two PrEP-001 Nasal Powder Formulations on Nasal Mucosa and Serum Cytokine Production Phase 1
Withdrawn NCT05557214 - Reducing Unnecessary Antibiotic Prescriptions in Primary Healthcare in Saskatchewan by Identifying High Prescribers N/A
Completed NCT01893762 - Innate Immune Response to (An)Aerobic Exercise in Rowing Athletes N/A
Completed NCT01396889 - Impact of Echinacea as Prophilaxis for Upper Respiratory Tract Infections in Children 1-5 Years N/A
Completed NCT05252468 - COVID-19 Prevention Trial: Effect of Prophylactic Use of TAFFIX™ on Infection Rate by SARS-CoV-2 Virus (COVID-19). N/A
Terminated NCT05279534 - Efficacy and Safety of L. Plantarum and P. Acidilactici in Children With Upper Respiratory Tract Infections N/A