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

Common Cold Clinical Trial

— PEP  

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"

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00065715
• Other study ID #: R01AT001428
• Secondary ID: R01AT001428Barre
• Status: Completed
• Phase: Phase 3
• First received: July 31, 2003
• Last updated: December 3, 2014
• Start date: September 2003
• Est. completion date: April 2013

Study information

• Verified date: December 2014
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical 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. 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.

Description:

As per Brief Summary

Recruitment information / eligibility

• Status: Completed
• Enrollment: 719
• Est. completion date: April 2013
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Common Cold

Intervention

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

Other:
• Blinded placebo
Blinded placebo - Coated tablet

Locations

Country	Name	City	State
United States	University of Wisconsin-Madison Department of Family Medicine	Madison	Wisconsin

Sponsors (3)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	National Center for Complementary and Integrative Health (NCCIH), National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration and severity of illness, as assessed by the Wisconsin Upper Respiratory Symptom Survey (WURSS-21)		twice daily during illness	No
Secondary	SF-8 general health-related quality of life		daily during illness	No
Secondary	perceived stress PSS-4		daily during illness	No
Secondary	optimism LOT		two days after enrollment	No
Secondary	patient satisfaction CARE		after doctor patient interaction	Yes
Secondary	feeling thermometer - EuroQol VAS		daily during illness	No
Secondary	IL-8 (inflammatory cytokine)from nasal wash		2 days after enrollment	No
Secondary	neutrophil count from nasal wash		two days after enrollment	No

External Links

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