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

Physician Recommended Nutriceuticals

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Osteoarthritis

Treatments: Dietary Supplement: placebo; Dietary Supplement: PRN Flex Omega Benefits® combination; Dietary Supplement: PRN Joint Health Formula

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT02333084

PRN 20141

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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120 participants in 3 patient groups, including a placebo group

Joint Health Product

Experimental group

Description:

natural dietary supplement

Treatment:

Dietary Supplement: PRN Joint Health Formula

Placebo

Placebo Comparator group

Description:

vegetable oil placebo

Treatment:

Dietary Supplement: placebo

Combination with Omega-3

Active Comparator group

Description:

combination with omega-3 fish oil

Treatment:

Dietary Supplement: PRN Flex Omega Benefits® combination