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

NCT ID: NCT00065715

Last Updated: 2014-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

719 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-09-30

Study Completion Date

2013-04-30

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;

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

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As per Brief Summary

Conditions

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Common Cold

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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A

No pills

Group Type NO_INTERVENTION

No interventions assigned to this group

B

Blinded placebo

Group Type PLACEBO_COMPARATOR

Blinded placebo

Intervention Type OTHER

Blinded placebo - Coated tablet

C

Echinacea - Blinded

Group Type EXPERIMENTAL

Echinacea

Intervention Type 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

D

Echinacea - Unblinded, Open Label

Group Type EXPERIMENTAL

Echinacea

Intervention Type 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

Interventions

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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

Intervention Type DIETARY_SUPPLEMENT

Blinded placebo

Blinded placebo - Coated tablet

Intervention Type OTHER

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
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

University of Wisconsin, Madison

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bruce Barrett, MD PhD

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Locations

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University of Wisconsin-Madison Department of Family Medicine

Madison, Wisconsin, United States

Site Status

Countries

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United States

References

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Montague E, Xu J, Chen PY, Asan O, Barrett BP, Chewning B. Modeling eye gaze patterns in clinician-patient interaction with lag sequential analysis. Hum Factors. 2011 Oct;53(5):502-16. doi: 10.1177/0018720811405986.

Reference Type DERIVED
PMID: 22046723 (View on PubMed)

Barrett B, Brown R, Rakel D, Mundt M, Bone K, Barlow S, Ewers T. Echinacea for treating the common cold: a randomized trial. Ann Intern Med. 2010 Dec 21;153(12):769-77. doi: 10.7326/0003-4819-153-12-201012210-00003.

Reference Type DERIVED
PMID: 21173411 (View on PubMed)

Related Links

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http://www.fammed.wisc.edu

Related Info

Other Identifiers

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R01AT001428

Identifier Type: NIH

Identifier Source: secondary_id

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BarrettB

Identifier Type: -

Identifier Source: secondary_id

R01AT001428

Identifier Type: NIH

Identifier Source: org_study_id

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