Clinical trial NCT02333084: The Influence Of a Natural Anti-Inflammatory Product On Levels Of Inflammatory Markers In Cases With Osteoarthritis Of Knee
Official title: The Influence Of a Natural Anti-Inflammatory Product On Levels Of Inflammatory Markers In Cases With Osteoarthritis Of Knee
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Osteoarthritis
Lead sponsor: Physician Recommended Nutriceuticals
Sponsor class: INDUSTRY
Collaborators: name: Rothman Institute Orthopedics
First posted: 2015-01-07
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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.

Primary outcomes:
measure: Human Inflammation Multi analyte profile (MAP) v1.0 in Synovial fluid and blood
timeFrame: 12 weeks
Secondary outcomes:
measure: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
timeFrame: 12 weeks
measure: Pain scores on Visual analog scale
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Rothman Institute
state: Pennsylvania
Study officials:
affiliation: Rothman Institute
name: Javad Parvizi, MD
role: PRINCIPAL_INVESTIGATOR
References: