Echinacea Versus Placebo Effect in Common Cold (Physician Echinacea Placebo) - Full Text View

Sponsor:	University of Wisconsin, Madison
Collaborators:	National Center for Complementary and Alternative Medicine (NCCAM) National Heart, Lung, and Blood Institute (NHLBI)
Information provided by:	University of Wisconsin, Madison
ClinicalTrials.gov Identifier:	NCT00065715

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;

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.

Condition	Intervention	Phase
Common Cold	Dietary Supplement: Echinacea Other: Blinded placebo	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy 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"

Resource links provided by NLM:

MedlinePlus related topics: Common Cold

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 ]

Estimated Enrollment:	720
Study Start Date:	September 2003
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: No Intervention No pills
B: Placebo Comparator Blinded placebo	Other: Blinded placebo Blinded placebo - Coated tablet
C: Experimental 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
D: Experimental 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

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 Alternative Medicine (NCCAM)

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

Responsible Party:	University of Wisconsin ( Bruce Barrett MD PhD )
Study ID Numbers:	R01 AT001428, R01AT001428, BarrettB
Study First Received:	July 31, 2003
Last Updated:	November 19, 2009
ClinicalTrials.gov Identifier:	NCT00065715 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by University of Wisconsin, Madison:

head cold
common cold
echinacea
placebo

Additional relevant MeSH terms:

Virus Diseases
RNA Virus Infections
Respiratory Tract Diseases

Respiratory Tract Infections
Common Cold
Picornaviridae Infections

ClinicalTrials.gov processed this record on November 27, 2009