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

Study Overview
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Brief Summary
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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 Description
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As per Brief Summary

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

Conditions
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Common Cold

Intervention / Treatment
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* Dietary Supplement: Echinacea
* Other: Blinded placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: A<br>No pills | |
| Placebo Comparator: B<br>Blinded placebo | Other: Blinded placebo<br>* Blinded placebo - Coated tablet<br>|
| Experimental: C<br>Echinacea - Blinded | Dietary Supplement: Echinacea<br>* 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<br>|
| Experimental: D<br>Echinacea - Unblinded, Open Label | Dietary Supplement: Echinacea<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration and severity of illness, as assessed by the Wisconsin Upper Respiratory Symptom Survey (WURSS-21) |  | twice daily during illness | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SF-8 general health-related quality of life |  | daily during illness | 
| perceived stress PSS-4 |  | daily during illness | 
| optimism LOT |  | two days after enrollment | 
| patient satisfaction CARE |  | after doctor patient interaction | 
| feeling thermometer - EuroQol VAS |  | daily during illness | 
| IL-8 (inflammatory cytokine)from nasal wash |  | 2 days after enrollment | 
| neutrophil count from nasal wash |  | two days after enrollment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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head cold, common cold, echinacea, placebo