NCT00065715

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

Placebo: Physician or Pill? A Randomized Trial in a Common Cold Model Funded by NIH NCCAM Under RFA "The Placebo Effect in Clinical Practice"

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 719 (actual)
• Sponsor: University of Wisconsin, Madison · Academic / Other
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

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.

Detailed description

As per Brief Summary

Conditions

• Common Cold

Interventions

Type	Name	Description
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

Timeline

• Start date: 2003-09-01
• Primary completion: 2008-08-01
• Completion: 2013-04-01
• First posted: 2003-08-01
• Last updated: 2014-12-04

Locations

1 site across 1 country: United States