Overview

This trial is active, not recruiting.

Condition osteoarthritis
Treatments prn joint health formula, placebo, prn flex omega benefits® combination
Phase phase 2/phase 3
Sponsor Physician Recommended Nutriceuticals
Collaborator Rothman Institute Orthopedics
Start date July 2014
End date July 2017
Trial size 120 participants
Trial identifier NCT02333084, PRN 20141

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose supportive care
Arm
(Experimental)
natural dietary supplement
prn joint health formula
(Placebo Comparator)
vegetable oil placebo
placebo
(Active Comparator)
combination with omega-3 fish oil
prn flex omega benefits® combination

Primary Outcomes

Measure
Human Inflammation Multi analyte profile (MAP) v1.0 in Synovial fluid and blood
time frame: 12 weeks

Secondary Outcomes

Measure
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
time frame: 12 weeks
Pain scores on Visual analog scale
time frame: 12 weeks

Eligibility Criteria

Male or female participants from 18 years up to 90 years old.

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.

Additional Information

Official title The Influence Of a Natural Anti-Inflammatory Product On Levels Of Inflammatory Markers In Cases With Osteoarthritis Of Knee
Principal investigator Javad Parvizi, MD
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Physician Recommended Nutriceuticals.