Echinacea Versus Placebo Effect in Common Cold (Physician Echinacea Placebo) (PEP)
This study has been completed.
Sponsor:
University of Wisconsin, Madison
Collaborators:
National Center for Complementary and Integrative Health (NCCIH)
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00065715
First received: July 31, 2003
Last updated: December 3, 2014
Last verified: December 2014
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Common Cold |
Dietary Supplement: Echinacea Other: Blinded placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official 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" |
Resource links provided by NLM:
MedlinePlus related topics:
Common Cold
Drug Information available for:
Echinacea
U.S. FDA Resources
Further study details as provided by University of Wisconsin, Madison:
Primary Outcome Measures:
- Duration and severity of illness, as assessed by the Wisconsin Upper Respiratory Symptom Survey (WURSS-21) [ Time Frame: twice daily during illness ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- SF-8 general health-related quality of life [ Time Frame: daily during illness ] [ Designated as safety issue: No ]
- perceived stress PSS-4 [ Time Frame: daily during illness ] [ Designated as safety issue: No ]
- optimism LOT [ Time Frame: two days after enrollment ] [ Designated as safety issue: No ]
- patient satisfaction CARE [ Time Frame: after doctor patient interaction ] [ Designated as safety issue: Yes ]
- feeling thermometer - EuroQol VAS [ Time Frame: daily during illness ] [ Designated as safety issue: No ]
- IL-8 (inflammatory cytokine)from nasal wash [ Time Frame: 2 days after enrollment ] [ Designated as safety issue: No ]
- neutrophil count from nasal wash [ Time Frame: two days after enrollment ] [ Designated as safety issue: No ]
| Enrollment: | 719 |
| Study Start Date: | September 2003 |
| Study Completion Date: | April 2013 |
| Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
No Intervention: A
No pills
|
|
|
Placebo Comparator: B
Blinded placebo
|
Other: Blinded placebo
Blinded placebo - Coated tablet
|
|
Experimental: C
Echinacea - Blinded
|
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
|
|
Experimental: D
Echinacea - Unblinded, Open Label
|
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
|
Detailed Description:
As per Brief Summary
Eligibility| Ages Eligible for Study: | 12 Years and older (Child, Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00065715
Please refer to this study by its ClinicalTrials.gov identifier: NCT00065715
Locations
| United States, Wisconsin | |
| University of Wisconsin-Madison Department of Family Medicine | |
| Madison, Wisconsin, United States, 53706-1490 | |
Sponsors and Collaborators
University of Wisconsin, Madison
National Center for Complementary and Integrative Health (NCCIH)
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
| Principal Investigator: | Bruce Barrett, MD PhD | University of Wisconsin, Madison |
More Information
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | University of Wisconsin, Madison |
| ClinicalTrials.gov Identifier: | NCT00065715 History of Changes |
| Other Study ID Numbers: | R01AT001428 BarrettB |
| Study First Received: | July 31, 2003 |
| Last Updated: | December 3, 2014 |
| Health Authority: | United States: Federal Government |
Keywords provided by University of Wisconsin, Madison:
|
head cold common cold echinacea placebo |
Additional relevant MeSH terms:
|
Common Cold Picornaviridae Infections RNA Virus Infections |
Virus Diseases Respiratory Tract Infections Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on September 26, 2016