The Influence Of a Natural Anti-Inflammatory Product On Levels Of Inflammatory Markers In Cases With Osteoarthritis Of Knee

Study Overview
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Brief Summary
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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.

Official Title
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The Influence Of a Natural Anti-Inflammatory Product On Levels Of Inflammatory Markers In Cases With Osteoarthritis Of Knee

Conditions
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Osteoarthritis

Intervention / Treatment
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* Dietary Supplement: PRN Joint Health Formula
* Dietary Supplement: placebo
* Dietary Supplement: PRN Flex Omega Benefits® combination


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥18 and ≤ 90 at the time of informed consent. Subjects with symptomatic moderate arthritis of the knee defined as per Kellgren-Lawrence grade II or III (Appendix B). Subjects with bilateral arthritis of the knee will also be recruited, but only one knee will be enrolled into the study. Ability to walk 50 feet unassisted. Lequesne's Functional Index score greater than 7 points Exclusion Criteria: Subjects with systemic inflammatory conditions such as inflammatory bowel disease, psoriasis, eczema, and others Subjects with seropositive or sero-negative inflammatory arthritis of the knee such as rheumatoid arthritis or ankylosing spondylitis. Subjects taking hormone replacement therapy Intra-articular corticosteroid injections 3 weeks prior to enrollment. Hypersensitivity to fish oil. Hypersensitivity to non-steroidal anti-inflammatory drugs, abnormal liver of kidney function tests, history of peptic ulceration and upper gastrointestinal hemorrhage, congestive heart failure, Hypertension (BP>140/90), cancer and hyperkalemia. Major abnormal findings on complete blood count, history of coagulopathies, hematological or neurological disorders. High alcohol intake (>2 standard drinks per day). Pregnant, breastfeeding or planning to become pregnant during the study Subjects awaiting surgery on the affected knee within three months. Consumption of any other vitamins/supplements will be allowed, provided the dose is not increased, and same brand is continued with. Also, the regimen should not contain the same active compounds tested in the PRN Joint health formula product. Vitamins/supplements cannot be introduced during a subject's participation in the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Joint Health Product<br>natural dietary supplement | Dietary Supplement: PRN Joint Health Formula<br> <br> |
| Placebo Comparator: Placebo<br>vegetable oil placebo | Dietary Supplement: placebo<br> <br> |
| Active Comparator: Combination with Omega-3<br>combination with omega-3 fish oil | Dietary Supplement: PRN Flex Omega Benefits® combination<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) |  | 12 weeks | 
| Pain scores on Visual analog scale |  | 12 weeks |