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| ID | Type | Description | Link |
|---|---|---|---|
| R01AT001428 | U.S. NIH Grant/Contract | View source | |
| BarrettB |
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| Name | Class |
|---|---|
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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;
As per Brief Summary
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | No Intervention | No pills | |
| B | Placebo Comparator | Blinded placebo |
|
| C | Experimental | Echinacea - Blinded |
|
| D | Experimental | Echinacea - Unblinded, Open Label |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Echinacea | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Duration and severity of illness, as assessed by the Wisconsin Upper Respiratory Symptom Survey (WURSS-21) | twice daily during illness |
| Measure | Description | Time Frame |
|---|---|---|
| SF-8 general health-related quality of life | daily during illness | |
| perceived stress PSS-4 | daily during illness | |
| optimism LOT |
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Inclusion criteria:
nasal discharge, nasal congestion, sneezing, or sore throat
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bruce Barrett, MD PhD | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wisconsin-Madison Department of Family Medicine | Madison | Wisconsin | 53706-1490 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22046723 | Derived | 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. | |
| 21173411 | Derived | 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. |
| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D003139 | Common Cold |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D010850 | Picornaviridae Infections |
| D012327 | RNA Virus Infections |
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| ID | Term |
|---|---|
| C000718679 | Echinacea extract |
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| Blinded placebo | Other | Blinded placebo - Coated tablet |
|
| two days after enrollment |
| patient satisfaction CARE | after doctor patient interaction |
| feeling thermometer - EuroQol VAS | daily during illness |
| IL-8 (inflammatory cytokine)from nasal wash | 2 days after enrollment |
| neutrophil count from nasal wash | two days after enrollment |
| D014777 |
| Virus Diseases |
| D012140 | Respiratory Tract Diseases |