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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00065715
Other study ID # R01AT001428
Secondary ID R01AT001428Barre
Status Completed
Phase Phase 3
First received July 31, 2003
Last updated December 3, 2014
Start date September 2003
Est. completion date April 2013

Study information

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

Clinical Trial 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.


Description:

As per Brief Summary


Recruitment information / eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Echinacea
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
Other:
Blinded placebo
Blinded placebo - Coated tablet

Locations

Country Name City State
United States University of Wisconsin-Madison Department of Family Medicine Madison Wisconsin

Sponsors (3)

Lead Sponsor Collaborator
University of Wisconsin, Madison National Center for Complementary and Integrative Health (NCCIH), National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

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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