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Completed

NCT Number: NCT00065715

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

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.

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Key information

Conditions

Common Cold Infections Picornaviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of Wisconsin-Madison Department of Family Medicine

Madison, Wisconsin, 53706-1490, United States

About this study

As per Brief Summary

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Echinacea

Dietary Supplement

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

Blinded placebo

Other

Blinded placebo - Coated tablet

Primary outcomes

  1. Duration and severity of illness, as assessed by the Wisconsin Upper Respiratory Symptom Survey (WURSS-21)

    Time frame: twice daily during illness

Secondary outcomes

  1. SF-8 general health-related quality of life

    Time frame: daily during illness

  2. perceived stress PSS-4

    Time frame: daily during illness

  3. optimism LOT

    Time frame: two days after enrollment

  4. patient satisfaction CARE

    Time frame: after doctor patient interaction

  5. feeling thermometer - EuroQol VAS

    Time frame: daily during illness

  6. IL-8 (inflammatory cytokine)from nasal wash

    Time frame: 2 days after enrollment

  7. neutrophil count from nasal wash

    Time frame: two days after enrollment

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)
  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study 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"

Acronym: PEP

Important dates

Study start
2003
Primary completion
2008
Study completion
2013
First posted
Aug 1, 2003
Registry last updated
Dec 4, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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