Common Cold
Conditions
Keywords
head cold, common cold, echinacea, placebo
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; 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
Interventions
DIETARY_SUPPLEMENTEchinacea
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
OTHERBlinded placebo
Blinded placebo - Coated tablet
Sponsors
National Center for Complementary and Integrative Health (NCCIH)
National Heart, Lung, and Blood Institute (NHLBI)
University of Wisconsin, Madison
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Duration and severity of illness, as assessed by the Wisconsin Upper Respiratory Symptom Survey (WURSS-21) | twice daily during illness |
Secondary
| Measure | Time frame |
|---|---|
| perceived stress PSS-4 | daily during illness |
| optimism LOT | two days after enrollment |
| patient satisfaction CARE | after doctor patient interaction |
| SF-8 general health-related quality of life | daily during illness |
| IL-8 (inflammatory cytokine)from nasal wash | 2 days after enrollment |
| neutrophil count from nasal wash | two days after enrollment |
| feeling thermometer - EuroQol VAS | daily during illness |
Countries
United States
Outcome results
None listed