Upper Respiratory InfectionsNCT00773435
Effects of Echinacea in Children
A study testing Echinacea purpurea 100 mg/ml in liquid formulation in people with Upper Respiratory Infections, run by University of Washington.
Trial summary
The goal of the this study is to determine if Echinacea purpurea stimulates the immune system in children. For the study, 40 healthy children, 6-11 years old will be randomized to receive Echinacea purpurea or placebo for 10 days in 3 consecutive months. Read more about this study
- Who is it for?
- Ages 6 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Upper Respiratory Infections
- What is being tested?
- Echinacea purpurea 100 mg/ml in liquid formulation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Nov 2008to Aug 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 6 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy children 6-11 years old
- Parent/Caregiver who can read and speak English
- One child per family
Who cannot join
- History of allergic reaction to Echinacea or related species
- History of asthma
- History of allergic rhinitis
- History of autoimmune disease
About this study
Official title: Assessing the in Vivo Effect of Echinacea Purpurea on Markers of Immune Activities in Children
The goal of the this study is to determine if Echinacea purpurea stimulates the immune system in children. For the study, 40 healthy children, 6-11 years old will be randomized to receive Echinacea purpurea or placebo for 10 days in 3 consecutive months. Blood samples will be obtained in the children just before starting study medication, during the first course of medication and either just prior to starting the second course of medication or 50 days following the last of the three courses of medication. Markers of immune activity in children receiving Echinacea or placebo will be compared.
Read the detailed description
This is an application to study the biologic activity of a specific formulation of Echinacea purpurea in children 6-11 years old. The goal of the study is to determine if Echinacea purpurea is associated with activation of immune markers including cytokines such as tumor necrosis factor alpha (TNF), interferon alpha, interferon gamma, and interleukins 2, 6, and 12 (IL-2, IL-6, and IL-12), as well CD25 and CD69 activation. A total of 40 study children will be randomized to receive either the Echinacea purpurea formulation or placebo for 10 consecutive days at the start of 3 consecutive 30-day periods. Blood samples will be obtained at baseline, at the time of "peak" TNF activity, and either 30 or 120 days after beginning the study medication. Prior to beginning this pediatric study "peak" TNF activity will be determined by administering the Echinacea purpurea to 3 adult volunteers for 10 days and doing frequent blood sampling during this period. If it is demonstrated that this formulation of E purpurea has biologic activity, a large randomized controlled trial is planned to determine if E purpurea can prevent upper respiratory tract infection (URI) in children 2-11 years old.
- Conditions
- Upper Respiratory Infections
- Being tested
- Echinacea purpurea 100 mg/ml in liquid formulation, placebo
- Keywords
- Upper respiratory tract infections, Children, 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 purpurea 100 mg/ml in liquid formulationBiological
10 ml BID for 10 consecutive days at the start of 3 consecutive 30 day periods
placeboOther
10 ml PO BID for 10 consecutive days at the beginning of 3 consecutive 30 day periods
| Study group | Role | What they receive |
|---|---|---|
| 1. Echinacea purpurea | Active comparator | Not described Receives: Biological: Echinacea purpurea 100 mg/ml in liquid formulation |
| 2. placebo | Placebo comparator | Not described Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
TNF levels
Measured: During first course of study medication
Secondary outcomes (3)
CD25/CD69 activation
Measured: 120 days
IL-2, IL-6, IL-12, interferon alpha, interferon gamma, TNF levels
Measured: 120 days
specific and general adverse events
Measured: 120 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2008 (estimated)
- Study startNov 2008
- Primary completionMay 2009 (estimated)
- Study completionAug 2009 (estimated)
Why it stopped: Decided to conduct study in adults first
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper Respiratory 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
- 0 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, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00773435
- Sponsor's protocol ID
- A41256
- Other IDs
- 5U01AT002400
- Status last verified
- Dec 2008
- First submitted
- 14 Oct 2008
- Last updated
- 2 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the in Vivo Effect of Echinacea Purpurea on Markers of Immune Activities in Children
- ClinicalTrials.gov ID
- NCT00773435
- Acronym / sponsor ID
- A41256
- Conditions
- Upper Respiratory Infections
- Keywords
- Upper respiratory tract infections, Children, Echinacea, Prevention, Immune modulation
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Decided to conduct study in adults first
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- Nov 2008
- Primary completion
- May 2009 (estimated)
- Study completion
- Aug 2009 (estimated)
- First posted
- 16 Oct 2008 (estimated)
- Results
- Not posted in the source record
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 the this study is to determine if Echinacea purpurea stimulates the immune system in children. For the study, 40 healthy children, 6-11 years old will be randomized to receive Echinacea purpurea or placebo for 10 days in 3 consecutive months. Blood samples will be obtained in the children just before starting study medication, during the first course of medication and either just prior to starting the second course of medication or 50 days following the last of the three courses of medication. Markers of immune activity in children receiving Echinacea or placebo will be compared.
Detailed description
This is an application to study the biologic activity of a specific formulation of Echinacea purpurea in children 6-11 years old. The goal of the study is to determine if Echinacea purpurea is associated with activation of immune markers including cytokines such as tumor necrosis factor alpha (TNF), interferon alpha, interferon gamma, and interleukins 2, 6, and 12 (IL-2, IL-6, and IL-12), as well CD25 and CD69 activation. A total of 40 study children will be randomized to receive either the Echinacea purpurea formulation or placebo for 10 consecutive days at the start of 3 consecutive 30-day periods. Blood samples will be obtained at baseline, at the time of "peak" TNF activity, and either 30 or 120 days after beginning the study medication. Prior to beginning this pediatric study "peak" TNF activity will be determined by administering the Echinacea purpurea to 3 adult volunteers for 10 days and doing frequent blood sampling during this period. If it is demonstrated that this formulation of E purpurea has biologic activity, a large randomized controlled trial is planned to determine if E purpurea can prevent upper respiratory tract infection (URI) in children 2-11 years old.
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 |
|---|---|---|
| 1. Echinacea purpurea | Active comparator | Biological: Echinacea purpurea 100 mg/ml in liquid formulation |
| 2. placebo | Placebo comparator | Other: placebo |
Who may qualify
- Ages
- 6 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Healthy children 6-11 years old
- Parent/Caregiver who can read and speak English
- One child per family
Key exclusion criteria (4 listed)
- History of allergic reaction to Echinacea or related species
- History of asthma
- History of allergic rhinitis
- History of autoimmune disease
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 100 mg/ml in liquid formulation10 ml BID for 10 consecutive days at the start of 3 consecutive 30 day periods | Biological | 1. Echinacea purpurea |
| placebo10 ml PO BID for 10 consecutive days at the beginning of 3 consecutive 30 day periods | Other | 2. placebo |
Primary outcome
TNF levels
Time frame: During first course of study medication
3 secondary outcomes
CD25/CD69 activation
Time frame: 120 days
IL-2, IL-6, IL-12, interferon alpha, interferon gamma, TNF levels
Time frame: 120 days
specific and general adverse events
Time frame: 120 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2015.
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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 principal investigator
University of Washington
Questions about this trial
What is this clinical trial studying?
A study testing Echinacea purpurea 100 mg/ml in liquid formulation in people with Upper Respiratory Infections, run by University of Washington.
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 3 inclusion and 4 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: withdrawn, as of the sponsor's last update on 2 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
TNF levels (time frame: During first course of study medication). 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 2 Dec 2015.