| July 31, 2003 |
| March 27, 2009 |
| September 2003 |
| October 2008 (final data collection date for primary outcome measure) |
| 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 ] |
| Same as current |
| Complete list of historical versions of study NCT00065715 on ClinicalTrials.gov Archive Site |
- 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 ]
|
| Same as current |
| |
| Echinacea Versus Placebo Effect in Common Cold (Physician Echinacea Placebo) |
| Placebo: Physician or Pill? A Randomized Trial in a Common Cold Model Funded by NIH NCCAM Under RFA "The Placebo Effect in Clinical Practice" |
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.
|
As per Brief Summary |
| Phase III |
| Interventional |
| Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
| Common Cold |
- Dietary Supplement: Echinacea
- Other: Blinded placebo
|
- No Intervention: No pills
- Placebo Comparator: Blinded placebo
- Experimental: Echinacea - Blinded
- Experimental: Echinacea - Unblinded, Open Label
|
| |
| |
| Active, not recruiting |
| 720 |
| December 2009 |
| October 2008 (final data collection date for primary outcome measure) |
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
|
| Both |
| 12 Years and older |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| United States |
| |
| NCT00065715 |
| Bruce Barrett MD PhD, University of Wisconsin |
| R01 AT001428, BarrettB |
| National Center for Complementary and Alternative Medicine (NCCAM) |
| National Heart, Lung, and Blood Institute (NHLBI) |
| Principal Investigator: |
Bruce Barrett, MD PhD |
University of Wisconsin, Madison |
|
|
| National Center for Complementary and Alternative Medicine (NCCAM) |
| March 2009 |
