Back to results

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

Primary Purpose

Osteoarthritis

Status

Unknown status

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

PRN Joint Health Formula

placebo

PRN Flex Omega Benefits® combination

About this trial

This is an interventional supportive care trial for Osteoarthritis

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Rothman Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Active Comparator

Arm Label

Joint Health Product

Placebo

Combination with Omega-3

Arm Description

natural dietary supplement

vegetable oil placebo

combination with omega-3 fish oil

Outcomes

Primary Outcome Measures

Human Inflammation Multi analyte profile (MAP) v1.0 in Synovial fluid and blood

46 different markers of inaflammation will be studies

Secondary Outcome Measures

Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

Pain scores on Visual analog scale

Full Information

NCT ID

NCT02333084

First Posted

October 6, 2014

Last Updated

August 2, 2016

Sponsor

Physician Recommended Nutriceuticals

Collaborators

Rothman Institute Orthopedics

1. Study Identification

Unique Protocol Identification Number

NCT02333084

Brief Title

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

2. Study Status

Record Verification Date

August 2016

Overall Recruitment Status

Unknown status

Study Start Date

July 2014 (undefined)

Primary Completion Date

July 2017 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Physician Recommended Nutriceuticals

Collaborators

Rothman Institute Orthopedics

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteoarthritis

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Joint Health Product

Arm Type

Experimental

Arm Description

natural dietary supplement

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

vegetable oil placebo

Arm Title

Combination with Omega-3

Arm Type

Active Comparator

Arm Description

combination with omega-3 fish oil

Intervention Type

Dietary Supplement

Intervention Name(s)

PRN Joint Health Formula

Intervention Type

Dietary Supplement

Intervention Name(s)

placebo

Intervention Type

Dietary Supplement

Intervention Name(s)

PRN Flex Omega Benefits® combination

Primary Outcome Measure Information:

Title

Human Inflammation Multi analyte profile (MAP) v1.0 in Synovial fluid and blood

Description

46 different markers of inaflammation will be studies

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

Time Frame

12 weeks

Title

Pain scores on Visual analog scale

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Javad Parvizi, MD

Organizational Affiliation

Rothman Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

Rothman Institute

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19107

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs