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

NCT ID: NCT02333084

Last Updated: 2016-08-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-31

Brief Summary

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.

Conditions

Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: QUADRUPLE

Study Groups

Joint Health Product

natural dietary supplement

Group Type: EXPERIMENTAL

PRN Joint Health Formula

Intervention Type: DIETARY_SUPPLEMENT

Placebo

vegetable oil placebo

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DIETARY_SUPPLEMENT

Combination with Omega-3

combination with omega-3 fish oil

Group Type: ACTIVE_COMPARATOR

PRN Flex Omega Benefits® combination

Intervention Type: DIETARY_SUPPLEMENT

Interventions

PRN Joint Health Formula

Intervention Type: DIETARY_SUPPLEMENT

placebo

Intervention Type: DIETARY_SUPPLEMENT

PRN Flex Omega Benefits® combination

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rothman Institute Orthopedics

UNKNOWN

Sponsor Role: collaborator

Physician Recommended Nutriceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Javad Parvizi, MD

Role: PRINCIPAL_INVESTIGATOR

Rothman Institute

Locations

Rothman Institute

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

PRN 20141

Identifier Type: -

Identifier Source: org_study_id