Common Cold Clinical Trial
— PEPOfficial 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"
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 |
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.
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | University of Wisconsin-Madison Department of Family Medicine | Madison | Wisconsin |
Lead Sponsor | Collaborator |
---|---|
University of Wisconsin, Madison | National Center for Complementary and Integrative Health (NCCIH), National Heart, Lung, and Blood Institute (NHLBI) |
United States,
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 |
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