Upper Respiratory Tract InfectionsNCT00860795
Immunologic Effects of Echinacea
A study testing Echinacea purpurea in people with Upper Respiratory Tract Infections, run by University of Washington at 1 site in United States.
Trial summary
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. Read more about this study
- 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
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2009to Aug 2009
- 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 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of the Immunologic Effects of Echinacea Purpurea in Adults
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.
- Conditions
- Upper Respiratory Tract Infections
- Being tested
- Echinacea purpurea, placebo
- Keywords
- Echinacea, prevention, immune modulation
- 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 purpureaBiological
Echinacea purpurea 100 mg/ml, 25 ml daily in 2 divided doses for 10 days
placeboDrug
placebo 25 ml daily in 2 divided doses for 10 days
| Study group | Role | What they receive |
|---|---|---|
| Echinacea | Active comparator | Not described Receives: Biological: Echinacea purpurea |
| placebo | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal Level of Tumor Necrosis Factor Alpha (pg/ml)
tumor necrosis factor alpha NK cells and evidence of CD25/69 activation
Measured: 10 days
Secondary outcomes (6)
Maximal Levels of Interferon Alpha (pg/ml)
interferon alpha was measured on days 2, 3, 7, 10 in peripheral blood mononuclear cells. The highest level on any of these days in each participant was chosen as the maximal level and used for the analysis.
Measured: 10 days
Maximal CD25/69 Activation (% of NK CD25/69+ Cells)
NK cells with evidence of CD25/69 activation were assessed on days 2, 3, 7, and 10. The highest percentage found on one of these days in each participant was categorized as the the maximal CD25/69 activation
Measured: 10 days
Adverse Effects
Measured: 30 days
Maximal Levels of Interleukin 2 (pg/ml)
interleukin 2 was measured on days 2, 3, 7, 10 in peripheral blood mononuclear cells. The highest level on any of these days in each participant was chosen as the maximal level and used for the analysis.
Measured: 10 days
Maximal Levels of Interleukin 6 (pg/ml)
interleukin 6 was measured on days 2, 3, 7, 10 in peripheral blood mononuclear cells. The highest level on any of these days in each participant was chosen as the maximal level and used for the analysis.
Measured: 10 days
Maximal Levels of Interleukin 12 (pg/ml)
interleukin 12 was measured on days 2, 3, 7, 10 in peripheral blood mononuclear cells. The highest level on any of these days in each participant was chosen as the maximal level and used for the analysis.
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2009 (estimated)
- Study startMar 2009
- Primary completionAug 2009
- Study completionAug 2009
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Principal investigator, James Taylor, University of Washington
- Investigators
- James A Taylor, MD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00860795
- Sponsor's protocol ID
- 09A1236
- Other IDs
- 5U01AT002400
- Status last verified
- Apr 2018
- First submitted
- 10 Mar 2009
- Last updated
- 1 May 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Immunologic Effects of Echinacea Purpurea in Adults
- ClinicalTrials.gov ID
- NCT00860795
- Acronym / sponsor ID
- 09A1236
- Conditions
- Upper Respiratory Tract Infections
- Keywords
- Echinacea, prevention, immune modulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- Mar 2009
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 12 Mar 2009 (estimated)
- Results
- Posted 17 Nov 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Echinacea | Active comparator | Biological: Echinacea purpurea |
| placebo | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
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 purpureaEchinacea purpurea 100 mg/ml, 25 ml daily in 2 divided doses for 10 days | Biological | Echinacea |
| placeboplacebo 25 ml daily in 2 divided doses for 10 days | Drug | placebo |
Primary outcome
Maximal Level of Tumor Necrosis Factor Alpha (pg/ml)
Time frame: 10 days
tumor necrosis factor alpha NK cells and evidence of CD25/69 activation
6 secondary outcomes
Maximal Levels of Interferon Alpha (pg/ml)
Time frame: 10 days
Maximal CD25/69 Activation (% of NK CD25/69+ Cells)
Time frame: 10 days
Adverse Effects
Time frame: 30 days
Maximal Levels of Interleukin 2 (pg/ml)
Time frame: 10 days
Maximal Levels of Interleukin 6 (pg/ml)
Time frame: 10 days
Maximal Levels of Interleukin 12 (pg/ml)
Time frame: 10 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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 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 6 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 1 May 2018. 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 17 Nov 2010). 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?
Maximal Level of Tumor Necrosis Factor Alpha (pg/ml) (time frame: 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 May 2018.