Common ColdPhase 3PEPNCT00065715
Echinacea Versus Placebo Effect in Common Cold (Physician Echinacea Placebo)
A Phase 3 study testing Echinacea in people with Common Cold, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
The design and interpretation of randomized trials is intimately connected to the use of "placebo". The nature and magnitude of placebo effects, however, is very poorly understood. This study will assess and compare placebo effects and physician interaction effects within a community-acquired common cold model. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Common Cold
- What is being tested?
- Echinacea
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 719 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2003to Apr 2013
- Phase
- Phase 3
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Suspected or known cold
- At least one of the following cold symptoms:
- nasal discharge, nasal congestion, sneezing, or sore throat
- Enrolled in school, for children 12 to 17 years of age
Who cannot join
- Pregnancy;
- Symptom duration > 36 hrs
- Concurrent use of antibiotics, antivirals, nasal steroids, decongestants or antihistamines;
- Anticipated need for symptom-relieving meds during cold
- Autoimmune/deficiency disease
- History of allergic rhinitis with current eye itching/sneezing
Show all 9Show fewer
- History of asthma w/current cough/SOB
- Prior study entry
- Allergy to Echinacea
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin-Madison Department of Family Medicine
Madison, Wisconsin, 53706-1490
About this study
Official title: Placebo: Physician or Pill? A Randomized Trial in a Common Cold Model Funded by NIH NCCAM Under RFA "The Placebo Effect in Clinical Practice"
The design and interpretation of randomized trials is intimately connected to the use of "placebo". The nature and magnitude of placebo effects, however, is very poorly understood. This study will assess and compare placebo effects and physician interaction effects within a community-acquired common cold model. The goal of this study is to assess two kinds of placebo affects and how physician interaction effects;
- The effect of receiving blinded placebo, compared to no treatment; and
- The effect of receiving open-label active Echinacea treatment compared to blinded active treatment.
Read the detailed description
As per Brief Summary
- Conditions
- Common Cold
- Being tested
- Echinacea, Blinded placebo
- Keywords
- head cold, common cold, echinacea, placebo
- Medical subject headings
- Common Cold
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EchinaceaDietary supplement
Echinacea phytochemical profile Each tablet is comprised of the equivalent of 1275 mg of echinacea root, as follows: A) Echinacea purpurea - 675 mg root yields 112.5 mg dried extract, standardized to contain 2.1mg alkamides. B) Echinacea angustifolia - 600 mg root yields 150 mg dried extract, standardized to contain 2.0 mg alkamides. Each batch of tablets is analyzed by Reversed Phase - High Peformance Liquid Chromatography to determine the levels of alkamides and caffeic derivatives present. Caffeic acid derivative levels are typically as follows: caftaric acid = 0.5 to 2.0 mg/tablet; cichoric acid = 3.4 to 8.5 mg/tablet; chlorogenic acid = < 0.5 mg/tablet; dicaffeoyl quinic acids (including cynarin) = 0.7 to 2.0 mg/tablet; echinacoside = 1.0 to 1.7 mg/tablet
Blinded placeboOther
Blinded placebo - Coated tablet
| Study group | Role | What they receive |
|---|---|---|
| A | No intervention | No pills |
| B | Placebo comparator | Blinded placebo Receives: Other: Blinded placebo |
| C | Experimental | Echinacea - Blinded Receives: Dietary Supplement: Echinacea |
| D | Experimental | Echinacea - Unblinded, Open Label Receives: Dietary Supplement: Echinacea |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration and severity of illness, as assessed by the Wisconsin Upper Respiratory Symptom Survey (WURSS-21)
Measured: twice daily during illness
Secondary outcomes (7)
SF-8 general health-related quality of life
Measured: daily during illness
perceived stress PSS-4
Measured: daily during illness
optimism LOT
Measured: two days after enrollment
patient satisfaction CARE
Measured: after doctor patient interaction
feeling thermometer - EuroQol VAS
Measured: daily during illness
IL-8 (inflammatory cytokine)from nasal wash
Measured: 2 days after enrollment
neutrophil count from nasal wash
Measured: two days after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2003 (estimated)
- Study startSep 2003
- Primary completionAug 2008
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Common ColdStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 719 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH), National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Bruce Barrett, MD PhD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00065715
- Sponsor's protocol ID
- R01AT001428
- Other IDs
- R01AT001428, BarrettB
- Acronym
- PEP
- Status last verified
- Dec 2014
- First submitted
- 31 Jul 2003
- Last updated
- 4 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Montague E, Xu J, Chen PY, Asan O, Barrett BP, Chewning B. Modeling eye gaze patterns in clinician-patient interaction with lag sequential analysis. Hum Factors. 2011 Oct;53(5):502-16. doi: 10.1177/0018720811405986.
PubMed 22046723Barrett B, Brown R, Rakel D, Mundt M, Bone K, Barlow S, Ewers T. Echinacea for treating the common cold: a randomized trial. Ann Intern Med. 2010 Dec 21;153(12):769-77. doi: 10.7326/0003-4819-153-12-201012210-00003.
PubMed 21173411
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Placebo: Physician or Pill? A Randomized Trial in a Common Cold Model Funded by NIH NCCAM Under RFA "The Placebo Effect in Clinical Practice"
- ClinicalTrials.gov ID
- NCT00065715
- Acronym / sponsor ID
- PEP / R01AT001428
- Conditions
- Common Cold
- Keywords
- head cold, common cold, echinacea, placebo
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 719 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH), National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Sep 2003
- Primary completion
- Aug 2008 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 1 Aug 2003 (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 design and interpretation of randomized trials is intimately connected to the use of "placebo". The nature and magnitude of placebo effects, however, is very poorly understood. This study will assess and compare placebo effects and physician interaction effects within a community-acquired common cold model. The goal of this study is to assess two kinds of placebo affects and how physician interaction effects;
- The effect of receiving blinded placebo, compared to no treatment; and
- The effect of receiving open-label active Echinacea treatment compared to blinded active treatment.
Detailed description
As per Brief Summary
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| A | No intervention | –No pills |
| B | Placebo comparator | Other: Blinded placeboBlinded placebo |
| C | Experimental | Dietary Supplement: EchinaceaEchinacea - Blinded |
| D | Experimental | Dietary Supplement: EchinaceaEchinacea - Unblinded, Open Label |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Suspected or known cold
- At least one of the following cold symptoms:
- nasal discharge, nasal congestion, sneezing, or sore throat
- Enrolled in school, for children 12 to 17 years of age
Key exclusion criteria (9 listed)
- Pregnancy;
- Symptom duration > 36 hrs
- Concurrent use of antibiotics, antivirals, nasal steroids, decongestants or antihistamines;
- Anticipated need for symptom-relieving meds during cold
- Autoimmune/deficiency 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 |
|---|---|---|
| EchinaceaEchinacea phytochemical profile Each tablet is comprised of the equivalent of 1275 mg of echinacea root, as follows: A) Echinacea purpurea - 675 mg root yields 112.5 mg dried extract, standardized to contain 2.1mg alkamides. B) Echinacea angustifolia - 600 mg root yields 150 mg dried extract, standardized to contain 2.0 mg alkamides. Each batch of tablets is analyzed by Reversed Phase - High Peformance Liquid Chromatography to determine the levels of alkamides and caffeic derivatives present. Caffeic acid derivative levels are typically as follows: caftaric acid = 0.5 to 2.0 mg/tablet; cichoric acid = 3.4 to 8.5 mg/tablet; chlorogenic acid = < 0.5 mg/tablet; dicaffeoyl quinic acids (including cynarin) = 0.7 to 2.0 mg/tablet; echinacoside = 1.0 to 1.7 mg/tablet | Dietary supplement | C, D |
| Blinded placeboBlinded placebo - Coated tablet | Other | B |
Primary outcome
Duration and severity of illness, as assessed by the Wisconsin Upper Respiratory Symptom Survey (WURSS-21)
Time frame: twice daily during illness
7 secondary outcomes
SF-8 general health-related quality of life
Time frame: daily during illness
perceived stress PSS-4
Time frame: daily during illness
optimism LOT
Time frame: two days after enrollment
patient satisfaction CARE
Time frame: after doctor patient interaction
feeling thermometer - EuroQol VAS
Time frame: daily during illness
IL-8 (inflammatory cytokine)from nasal wash
Time frame: 2 days after enrollment
neutrophil count from nasal wash
Time frame: two days after enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2014.
- Derived from this study: PubMed 22046723Montague E, Xu J, Chen PY, Asan O, Barrett BP, Chewning B. Modeling eye gaze patterns in clinician-patient interaction with lag sequential analysis. Hum Factors. 2011 Oct;53(5):502-16. doi: 10.1177/0018720811405986.
- Derived from this study: PubMed 21173411Barrett B, Brown R, Rakel D, Mundt M, Bone K, Barlow S, Ewers T. Echinacea for treating the common cold: a randomized trial. Ann Intern Med. 2010 Dec 21;153(12):769-77. doi: 10.7326/0003-4819-153-12-201012210-00003.
- Related InfoLink provided by the sponsor.
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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.
Bruce Barrett, MD PhD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Echinacea in people with Common Cold, run by University of Wisconsin, Madison 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 4 inclusion and 9 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 4 Dec 2014. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Duration and severity of illness, as assessed by the Wisconsin Upper Respiratory Symptom Survey (WURSS-21) (time frame: twice daily during illness). 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 NCT00065715, which also lists 2 linked publications.
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 4 Dec 2014.