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

This study has been completed.
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
ClinicalTrials.gov Identifier:
NCT00065715
First received: July 31, 2003
Last updated: December 3, 2014
Last verified: December 2014
History of Changes
  Purpose

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 Intervention Phase
Common Cold
 Dietary Supplement: Echinacea
Other: Blinded placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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"

Resource links provided by NLM:

MedlinePlus related topics: Common Cold
Drug Information available for: Echinacea
U.S. FDA Resources

Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • Duration and severity of illness, as assessed by the Wisconsin Upper Respiratory Symptom Survey (WURSS-21) [ Time Frame: twice daily during illness ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • SF-8 general health-related quality of life [ Time Frame: daily during illness ] [ Designated as safety issue: No ]
  • perceived stress PSS-4 [ Time Frame: daily during illness ] [ Designated as safety issue: No ]
  • optimism LOT [ Time Frame: two days after enrollment ] [ Designated as safety issue: No ]
  • patient satisfaction CARE [ Time Frame: after doctor patient interaction ] [ Designated as safety issue: Yes ]
  • feeling thermometer - EuroQol VAS [ Time Frame: daily during illness ] [ Designated as safety issue: No ]
  • IL-8 (inflammatory cytokine)from nasal wash [ Time Frame: 2 days after enrollment ] [ Designated as safety issue: No ]
  • neutrophil count from nasal wash [ Time Frame: two days after enrollment ] [ Designated as safety issue: No ]
Enrollment: 719
Study Start Date: September 2003
Study Completion Date: April 2013
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

As per Brief Summary

  Eligibility
Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00065715

Locations
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
Principal Investigator: Bruce Barrett, MD PhD University of Wisconsin, Madison
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

No publications provided by University of Wisconsin, Madison

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

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00065715     History of Changes
Other Study ID Numbers: R01 AT001428, R01AT001428, BarrettB
Study First Received: July 31, 2003
Last Updated: December 3, 2014
Health Authority: United States: Federal Government

Keywords provided by University of Wisconsin, Madison:
head cold
common cold
echinacea
placebo

Additional relevant MeSH terms:
Common Cold
Picornaviridae Infections
RNA Virus Infections
 Respiratory Tract Diseases
Respiratory Tract Infections
Virus Diseases

ClinicalTrials.gov processed this record on February 27, 2015