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

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.

Study Overview

• Status: Unknown
• Conditions: Osteoarthritis
• Intervention / Treatment: Dietary supplement: placebo; Dietary supplement: PRN Joint Health Formula; Dietary supplement: PRN Flex Omega Benefits® combination

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Rothman Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Physician Recommended Nutriceuticals
• Collaborators: Rothman Institute Orthopedics
• Investigators: Principal Investigator: Javad Parvizi, MD, Rothman Institute

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Anticipated): July 1, 2017

Study Registration Dates

• First Submitted: October 6, 2014
• First Submitted That Met QC Criteria: January 6, 2015
• First Posted (Estimate): January 7, 2015

Study Record Updates

• Last Update Posted (Estimate): August 4, 2016
• Last Update Submitted That Met QC Criteria: August 2, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: PRN 20141