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

Phase 2

• Conditions: Osteoarthritis
• Interventions: Dietary Supplement: placebo; Dietary Supplement: PRN Flex Omega Benefits® combination; Dietary Supplement: PRN Joint Health Formula

• Registration Number: NCT02333084
• Lead Sponsor: Physician Recommended Nutriceuticals

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-07
• Study First Submitted: 2014-10-06
• Study First Submitted QC: 2015-01-06
• Study First Posted: 2015-01-07
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-02
• Last Update Posted: 2016-08-04
• Primary Completion: 2017-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	placebo	vegetable oil placebo
Combination with Omega-3	PRN Flex Omega Benefits® combination	combination with omega-3 fish oil
Joint Health Product	PRN Joint Health Formula	natural dietary supplement

Primary Outcome Measures

Name	Time	Method
Human Inflammation Multi analyte profile (MAP) v1.0 in Synovial fluid and blood	12 weeks	46 different markers of inaflammation will be studies

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Rothman Institute; 🇺🇸 Philadelphia, Pennsylvania, United States