Clinical Trial: Echinacea Versus Placebo Effect in Common Cold (Physician Echinacea Placebo)
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
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"
Brief 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;
- 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.
Detailed Summary: As per Brief Summary
Sponsor: University of Wisconsin, Madison
Current Primary Outcome: Duration and severity of illness, as assessed by the Wisconsin Upper Respiratory Symptom Survey (WURSS-21) [ Time Frame: twice daily during illness ]
Original Primary Outcome:
Current Secondary Outcome:
- SF-8 general health-related quality of life [ Time Frame: daily during illness ]
- perceived stress PSS-4 [ Time Frame: daily during illness ]
- optimism LOT [ Time Frame: two days after enrollment ]
- patient satisfaction CARE [ Time Frame: after doctor patient interaction ]
- feeling thermometer - EuroQol VAS [ Time Frame: daily during illness ]
- IL-8 (inflammatory cytokine)from nasal wash [ Time Frame: 2 days after enrollment ]
- neutrophil count from nasal wash [ Time Frame: two days after enrollment ]
Original Secondary Outcome:
Information By: University of Wisconsin, Madison
Dates:
Date Received: July 31, 2003
Date Started: September 2003
Date Completion:
Last Updated: December 3, 2014
Last Verified: December 2014
