The Influence Of a Natural Anti-Inflammatory Product On Levels Of Inflammatory Markers In Cases With Osteoarthritis Of Knee
| Status: | Recruiting |
|---|---|
| Conditions: | Arthritis, Osteoarthritis (OA) |
| Therapuetic Areas: | Rheumatology |
| Healthy: | No |
| Age Range: | 18 - 90 |
| Updated: | 4/21/2016 |
| Start Date: | July 2014 |
| Contact: | Zubin Shah |
| Email: | zshah@prnomegahealth.com |
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.
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.
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.
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