Upper Respiratory Tract InfectionsNCT01129128

Three Arm Trial of Immune Effects of Echinacea

A study testing Echinacea purpurea product in people with Upper Respiratory Tract Infections, run by University of Washington at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 21 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Upper Respiratory Tract Infections
What is being tested?: Echinacea purpurea product
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 67 participants
Where: 1 siteUnited States
Study dates: May 2010to Mar 2011
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Bastyr University
Kenmore, Washington, 98028

Other trials in United States

About this study

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

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
Being tested: Echinacea purpurea product, Placebo
Keywords: Echinacea, immune modulation, prevention
Medical subject headings: Respiratory Tract Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Echinacea purpurea productBiological
5 ml by mouth 3 times per day for 10 days
Echinacea purpurea productBiological
1 ml by mouth 3 times per day for 10 days
PlaceboBiological
either 5 ml or 1 ml by mouth three times per day for 10 days

Study groups in NCT01129128
Study group	Role	What they receive
Echinacea preparation 1	Active comparator	Commercially available Echinacea purpurea product Receives: Biological: Echinacea purpurea product
Echinacea preparation 2	Active comparator	Commercially available Echinacea purpurea product Receives: Biological: Echinacea purpurea product
Placebo	Placebo comparator	Inert liquid that is similar in appearance and taste to the active Echinacea products Receives: Biological: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Peak Level of TNF Alpha
Highest level of TNF alpha while taking study medication
Measured: 1-10 days after starting study medication

Secondary outcomes (4)

Peak Level IL-6
Highest level of IL-6 while taking study medication
Measured: 1-10 days after starting study medication
Peak Level Interferon Gamma
Highest level of Interferon gamma while taking study medication
Measured: 1-10 days after starting study medication
Peak Level IL-2
Highest level of IL-2 while taking study medication
Measured: 1-10 days after starting study medication
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
Measured: 1- 30 days after starting study medication

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2010Mar 2011

First posted24 May 2010 (estimated)
Study startMay 2010
Primary completionMar 2011
Study completionMar 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Upper Respiratory Tract InfectionsStudies of the same condition, open and under way.
More trials run by University of WashingtonThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 67 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01129128
Sponsor's protocol ID: 10A1276
Status last verified: Jun 2012
First submitted: 14 May 2010
Last updated: 21 Jun 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Upper Respiratory Tract Infections trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 3-arm Randomized Controlled Trial Assessing the in Vivo Effect of an Echinacea Purpurea on Immune Markers in Adults
ClinicalTrials.gov ID: NCT01129128
Acronym / sponsor ID: 10A1276
Conditions: Upper Respiratory Tract Infections
Keywords: Echinacea, immune modulation, prevention
Study type: Interventional
Recruitment status: Completed
Enrolment: 67 participants (actual)
Lead sponsor: University of WashingtonUniversity, hospital or other
Collaborators: National Center for Complementary and Integrative Health (NCCIH)
Study start: May 2010
Primary completion: Mar 2011 (actual)
Study completion: Mar 2011 (actual)
First posted: 24 May 2010 (estimated)
Results: Posted 5 Jun 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 3

Arm	Type	Receives
Echinacea preparation 1	Active comparator	Biological: Echinacea purpurea productCommercially available Echinacea purpurea product
Echinacea preparation 2	Active comparator	Biological: Echinacea purpurea productCommercially available Echinacea purpurea product
Placebo	Placebo comparator	Biological: PlaceboInert liquid that is similar in appearance and taste to the active Echinacea products

Who may qualify

Ages: 21 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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.

Key exclusion criteria (7 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Echinacea purpurea product5 ml by mouth 3 times per day for 10 days	Biological	Echinacea preparation 1
Echinacea purpurea product1 ml by mouth 3 times per day for 10 days	Biological	Echinacea preparation 2
Placeboeither 5 ml or 1 ml by mouth three times per day for 10 days	Biological	Placebo

Primary outcome

Peak Level of TNF Alpha
Time frame: 1-10 days after starting study medication
Highest level of TNF alpha while taking study medication

4 secondary outcomes

Peak Level IL-6
Time frame: 1-10 days after starting study medication
Peak Level Interferon Gamma
Time frame: 1-10 days after starting study medication
Peak Level IL-2
Time frame: 1-10 days after starting study medication
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Time frame: 1- 30 days after starting study medication

Results and safety

Results posted to the registry on 5 Jun 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Commercially Available Echinacea Product #1 (5 ml/Dose)	22	19
Commercially Available Echinacea Product #2 (1 ml/Dose)	22	18
Placebo	23	19

Primary outcome: Peak Level of TNF Alpha

Time frame: 1-10 days after starting study medication. Mean (Standard Deviation). Unit: pg/ml

Measure	Commercially Available Echinacea Product #1 (5 ml/Dose) n = 22	Commercially Available Echinacea Product #2 (1 ml/Dose) n = 22	Placebo n = 22
Value	436 (510)	1467 (2330)	721 (1272)

Commercially Available Echinacea Product #1 (5 ml/Dose) vs Placebo: Mean Difference (Final Values): -173, p = 0.87, Regression, Linear
Commercially Available Echinacea Product #2 (1 ml/Dose) vs Placebo: Mean Difference (Final Values): 705, p = 0.82, Regression, Linear

Population analysed: Data analyzed on any participant who TNF alpha level was obtained on 1 or more days while on study medication.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: day 1 (first dose of study medication) through day 30. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Commercially Available Echinacea Product #1 (5 ml/Dose)	0 of 22 (0%)	14 of 22 (63.6%)	Not reported
Commercially Available Echinacea Product #2 (1 ml/Dose)	0 of 22 (0%)	18 of 22 (81.8%)	Not reported
Placebo	0 of 22 (0%)	16 of 22 (72.7%)	Not reported

Limitations and caveats (from the sponsor): Levels of TNF alpha, IL-6, IL-2 and Interferon gamma varied widely limiting chance of detecting differences.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Upper Respiratory Tract Infections

Not yet recruitingPhase 4
SPARK Study - Sympathetic Periarterial Radial Block in Healthy Volunteers
Healthy Volunteers, Sympathetic Activity
Not yet recruiting
Influence of Patient Positioning During Nasal Lavage
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Recruiting
Safety and Efficacy of NTP in Thyroid Surgery: Pilot Study on Morbidity Prevention and Adjuvant Oncological Control
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RecruitingObservational study
A Study to Evaluate Treating Watery Noses With Cryotherapy in the Clinic Setting. This is Cold Therapy, Freezing the Issues at the Back of the Nose to Ease Symptoms.
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Not yet recruiting
Evaluating Sucrose and Cold Oral Interventions for the Treatment of Oral Pruritus During Allergy Procedures.
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

James A Taylor, MD principal investigator

University of Washington

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Echinacea purpurea product in people with Upper Respiratory Tract Infections, run by University of Washington at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Jun 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Peak Level of TNF Alpha (time frame: 1-10 days after starting study medication). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01129128.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2012.