Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
National Center for Complementary and Alternative Medicine (NCCAM) National Heart, Lung, and Blood Institute (NHLBI) |
---|---|
Information provided by: | National Center for Complementary and Alternative Medicine (NCCAM) |
ClinicalTrials.gov Identifier: | NCT00065715 |
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;
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" |
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
|
As per Brief Summary
Ages Eligible for Study: | 12 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
nasal discharge, nasal congestion, sneezing, or sore throat
Exclusion criteria:
Contact: Bruce P Barrett, MD PhD | 608-263-2220 | bruce.barrett@fammed.wisc.edu |
Contact: Shari Barlow | 608-333-2653 | shari.barlow@fammed.wisc.edu |
United States, Wisconsin | |
University of Wisconsin-Madison Department of Family Medicine | Recruiting |
Madison, Wisconsin, United States, 53706-1490 | |
Contact: Bruce P Barrett, MD PhD 608-263-2220 bruce.barrett@fammed.wisc.edu | |
Contact: Shari Barlow 608-333-2653 shari.barlow@fammed.wisc.edu | |
Principal Investigator: Bruce Barrett, MS, MD, PhD |
Principal Investigator: | Bruce Barrett, MD PhD | University of Wisconsin, Madison |
Responsible Party: | University of Wisconsin ( Bruce Barrett MD PhD ) |
Study ID Numbers: | R01 AT001428, BarrettB |
Study First Received: | July 31, 2003 |
Last Updated: | August 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00065715 |
Health Authority: | United States: Federal Government |
head cold common cold echinacea placebo |
Virus Diseases Respiratory Tract Diseases Respiratory Tract Infections Common Cold Picornaviridae Infections |
RNA Virus Infections |