Natural Anti-Inflammatory Supplements for Osteoarthritis

Phase 2 & 3

Waitlist Available

Led By Javad Parvizi, MD

Research Sponsored by Physician Recommended Nutriceuticals

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Lequesne's Functional Index score greater than 7 points

Subjects with symptomatic moderate arthritis of the knee defined as per Kellgren-Lawrence grade II or III

Must not have

Subjects with systemic inflammatory conditions such as inflammatory bowel disease, psoriasis, eczema, and others

Subjects taking hormone replacement therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks

Summary

This trial will test a new joint supplement against a placebo and another supplement. It will start in July 2014 and finish in July 2015, enrolling subjects at random.

Who is the study for?

Adults aged 18-90 with moderate knee osteoarthritis, able to walk unassisted and have a specific score on the Lequesne's Functional Index can join. Excluded are those with systemic inflammatory conditions, hormone therapy users, recent recipients of corticosteroid injections in the knee, fish oil allergies, heavy drinkers, pregnant or breastfeeding women, and those taking certain supplements.

What is being tested?

The study is testing an anti-inflammatory product called PRN Joint Health Formula against a placebo and another combination product (PRN Flex Omega Benefits®). Participants will be randomly assigned to one of these treatments in equal numbers at each site.

What are the potential side effects?

Potential side effects may include allergic reactions for those sensitive to fish oil (in the active treatment groups), digestive issues due to supplement intake, and possible interactions with other medications or supplements not disclosed.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My knee pain affects my daily activities significantly.

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I have moderate knee arthritis.

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I can walk 50 feet by myself.

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I am between 18 and 90 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a condition like inflammatory bowel disease, psoriasis, or eczema.

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I am currently on hormone replacement therapy.

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I do not have allergies to NSAIDs, liver or kidney issues, history of stomach ulcers or bleeding, heart failure, high blood pressure, cancer, or high potassium levels.

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I do not have significant blood, clotting, or nerve disorders.