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| Name | Class |
|---|---|
| Capital Health, Canada | OTHER |
The purpose of the Study is to determine the prophylactic effects of CVT-E002 treatment for upper respiratory tract infections in healthy adult employees working with residents in continuing care facilities. It is hypothesized that the use of CVT-E002 will effectively reduce the incidence, severity and duration of upper respiratory infections among the participants when compared to placebo.
Eligible continuing care employees will be randomly assigned to either the treatment or placebo group with equal numbers in each group. The treatment will consist of taking two capsules of CVT-E002 (400mg)or placebo every morning, after breakfast, for a period of 12 weeks. The subjects will be given an assessment form to log specific symptoms on a daily basis if they get a cold.
Symptoms include sore throat, runny nose, nasal congestion, hoarseness, cough, earaches, and fever. Subjects will be required to maintain the same dosing even during an upper respiratory infection and will be requested not to take any additional medication for their upper respiratory infection unless prescribed by their family physicians.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CVT-E002 (Cold-FX); a natural health product | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| To determine the efficacy of CVT-E002 in reducing the number of upper respiratory infections during the study. |
| Measure | Description | Time Frame |
|---|---|---|
| To test if the prophylactic management with CVT-E002 decreases the severity and duration of symptoms related to an upper respiratory tract infection. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gerry Predy, MD | Capital Health, Canada | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Capital Care Group Continuing Care facilities | Edmonton | Alberta | T5K 2J8 | Canada |
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| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D003139 | Common Cold |
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D007239 | Infections |
| D012140 | Respiratory Tract Diseases |
| D010850 | Picornaviridae Infections |
| D012327 | RNA Virus Infections |
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| ID | Term |
|---|---|
| C511203 | COLD-fX |
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| D014777 |
| Virus Diseases |
| D009976 | Orthomyxoviridae Infections |