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

Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02333084
• Other study ID #: PRN 20141
• Status: Active, not recruiting
• Phase: Phase 2/Phase 3
• First received: October 6, 2014
• Last updated: August 2, 2016
• Start date: July 2014

Study information

• Verified date: August 2016
• Source: Physician Recommended Nutriceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Dietary Supplement:
• PRN Joint Health Formula

• placebo

• PRN Flex Omega Benefits® combination

Locations

Country	Name	City	State
United States	Rothman Institute	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Physician Recommended Nutriceuticals	Rothman Institute Orthopedics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Human Inflammation Multi analyte profile (MAP) v1.0 in Synovial fluid and blood	46 different markers of inaflammation will be studies	12 weeks	No
Secondary	Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)		12 weeks	No
Secondary	Pain scores on Visual analog scale		12 weeks	No