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Echinacea Versus Placebo Effect in Common Cold (Physician Echinacea Placebo) (PEP)

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ClinicalTrials.gov Identifier: NCT00065715
Recruitment Status : Completed
First Posted : August 1, 2003
Last Update Posted : December 4, 2014
Sponsor:
Collaborators:
National Center for Complementary and Integrative Health (NCCIH)
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
University of Wisconsin, Madison

Study Description
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Brief 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. The goal of this study is to assess two kinds of placebo affects and how physician interaction effects;

  1. The effect of receiving blinded placebo, compared to no treatment; and
  2. The effect of receiving open-label active Echinacea treatment compared to blinded active treatment.

Condition or disease Intervention/treatment Phase
Common Cold Dietary Supplement: Echinacea Other: Blinded placebo Phase 3

Detailed Description:
As per Brief Summary
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 719 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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"
Study Start Date : September 2003
Actual Primary Completion Date : August 2008
Actual Study Completion Date : April 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Common Cold
Drug Information available for: Echinacea

Arms and Interventions
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Arm Intervention/treatment
No Intervention: A
No pills
Placebo Comparator: B
Blinded placebo
 Other: Blinded placebo
Blinded placebo - Coated tablet
Experimental: C
Echinacea - Blinded
 Dietary Supplement: Echinacea
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
Experimental: D
Echinacea - Unblinded, Open Label
 Dietary Supplement: Echinacea
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


Outcome Measures
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Primary Outcome Measures :
  1. Duration and severity of illness, as assessed by the Wisconsin Upper Respiratory Symptom Survey (WURSS-21) [ Time Frame: twice daily during illness ]

Secondary Outcome Measures :
  1. SF-8 general health-related quality of life [ Time Frame: daily during illness ]
  2. perceived stress PSS-4 [ Time Frame: daily during illness ]
  3. optimism LOT [ Time Frame: two days after enrollment ]
  4. patient satisfaction CARE [ Time Frame: after doctor patient interaction ]
  5. feeling thermometer - EuroQol VAS [ Time Frame: daily during illness ]
  6. IL-8 (inflammatory cytokine)from nasal wash [ Time Frame: 2 days after enrollment ]
  7. neutrophil count from nasal wash [ Time Frame: two days after enrollment ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • 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

Exclusion criteria:

  • 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
  • History of asthma w/current cough/SOB
  • Prior study entry
  • Allergy to Echinacea
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00065715


Locations
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United States, Wisconsin
University of Wisconsin-Madison Department of Family Medicine
Madison, Wisconsin, United States, 53706-1490
Sponsors and Collaborators
University of Wisconsin, Madison
National Center for Complementary and Integrative Health (NCCIH)
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: Bruce Barrett, MD PhD University of Wisconsin, Madison
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00065715    
Other Study ID Numbers: R01AT001428 ( U.S. NIH Grant/Contract )
R01AT001428 ( U.S. NIH Grant/Contract )
BarrettB
First Posted: August 1, 2003    Key Record Dates
Last Update Posted: December 4, 2014
Last Verified: December 2014
Keywords provided by University of Wisconsin, Madison:
head cold
common cold
echinacea
placebo
Additional relevant MeSH terms:
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Common Cold
Respiratory Tract Infections
Infections
Picornaviridae Infections
 RNA Virus Infections
Virus Diseases
Respiratory Tract Diseases