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| Name | Class |
|---|---|
| Rothman Institute Orthopedics | UNKNOWN |
This is a randomized, placebo controlled study. The first subject is expected to be enrolled in July 2014, and the last subject is expected to complete the study by July 2015. Each subject will be provided with the PRN Joint Comfort Formula, placebo or PRN Flex Omega Benefits® combination depending on randomization (1:1:1 at each site) during the course of the study. Instructions and frequency of use will be determined by the labelling.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Joint Health Product | Experimental | natural dietary supplement |
|
| Placebo | Placebo Comparator | vegetable oil placebo |
|
| Combination with Omega-3 | Active Comparator | combination with omega-3 fish oil |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PRN Joint Health Formula | Dietary Supplement |
| ||
| placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Human Inflammation Multi analyte profile (MAP) v1.0 in Synovial fluid and blood | 46 different markers of inaflammation will be studies | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) | 12 weeks | |
| Pain scores on Visual analog scale | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Javad Parvizi, MD | Rothman Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rothman Institute | Philadelphia | Pennsylvania | 19107 | United States |
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|
| PRN Flex Omega Benefits® combination | Dietary Supplement |
|
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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