NCT00065715

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. 1.The effect of receiving blinded placebo, compared to no treatment; and
  2. 2.The effect of receiving open-label active Echinacea treatment compared to blinded active treatment.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
719

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Sep 2003

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 31, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 1, 2003

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2003

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
4.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
Last Updated

December 4, 2014

Status Verified

December 1, 2014

Enrollment Period

4.9 years

First QC Date

July 31, 2003

Last Update Submit

December 3, 2014

Conditions

Common Cold

Keywords

head coldcommon coldechinaceaplacebo

Outcome Measures

Primary Outcomes (1)

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

    twice daily during illness

Secondary Outcomes (7)

  • 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

  • +2 more secondary outcomes

Study Arms (4)

A

NO INTERVENTION

No pills

B

PLACEBO COMPARATOR

Blinded placebo

Other: Blinded placebo

C

EXPERIMENTAL

Echinacea - Blinded

Dietary Supplement: Echinacea

D

EXPERIMENTAL

Echinacea - Unblinded, Open Label

Dietary Supplement: Echinacea

Interventions

EchinaceaDIETARY_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

CD
Blinded placeboOTHER

Blinded placebo - Coated tablet

B

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Wisconsin-Madison Department of Family Medicine

Madison, Wisconsin, 53706-1490, United States

Location

Related Publications (2)

  • 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.

    PMID: 22046723DERIVED

  • 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.

    PMID: 21173411DERIVED

Related Links

MeSH Terms

Conditions

Common Cold

Interventions

Echinacea extract

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsPicornaviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Study Officials

  • Bruce Barrett, MD PhD

    University of Wisconsin, Madison

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 31, 2003

First Posted

August 1, 2003

Study Start

September 1, 2003

Primary Completion

August 1, 2008

Study Completion

April 1, 2013

Last Updated

December 4, 2014

Record last verified: 2014-12

Locations

US(1)