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Dietary Supplement
Natural Anti-Inflammatory Supplements for Osteoarthritis
Phase 2 & 3
Waitlist Available
Led By Javad Parvizi, MD
Research Sponsored by Physician Recommended Nutriceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Lequesne's Functional Index score greater than 7 points
Subjects with symptomatic moderate arthritis of the knee defined as per Kellgren-Lawrence grade II or III
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights
Study Summary
This trial will test a new joint supplement against a placebo and another supplement. It will start in July 2014 and finish in July 2015, enrolling subjects at random.
Who is the study for?
Adults aged 18-90 with moderate knee osteoarthritis, able to walk unassisted and have a specific score on the Lequesne's Functional Index can join. Excluded are those with systemic inflammatory conditions, hormone therapy users, recent recipients of corticosteroid injections in the knee, fish oil allergies, heavy drinkers, pregnant or breastfeeding women, and those taking certain supplements.Check my eligibility
What is being tested?
The study is testing an anti-inflammatory product called PRN Joint Health Formula against a placebo and another combination product (PRN Flex Omega Benefits®). Participants will be randomly assigned to one of these treatments in equal numbers at each site.See study design
What are the potential side effects?
Potential side effects may include allergic reactions for those sensitive to fish oil (in the active treatment groups), digestive issues due to supplement intake, and possible interactions with other medications or supplements not disclosed.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My knee pain affects my daily activities significantly.
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I have moderate knee arthritis.
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I can walk 50 feet by myself.
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I am between 18 and 90 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Human Inflammation Multi analyte profile (MAP) v1.0 in Synovial fluid and blood
Secondary outcome measures
Pain scores on Visual analog scale
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Joint Health ProductExperimental Treatment1 Intervention
natural dietary supplement
Group II: Combination with Omega-3Active Control1 Intervention
combination with omega-3 fish oil
Group III: PlaceboPlacebo Group1 Intervention
vegetable oil placebo
Find a Location
Who is running the clinical trial?
Physician Recommended NutriceuticalsLead Sponsor
4 Previous Clinical Trials
322 Total Patients Enrolled
Rothman Institute OrthopedicsUNKNOWN
Javad Parvizi, MDPrincipal InvestigatorRothman Institute
2 Previous Clinical Trials
130 Total Patients Enrolled
1 Trials studying Osteoarthritis
80 Patients Enrolled for Osteoarthritis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 18 and 90 years old.I have a condition like inflammatory bowel disease, psoriasis, or eczema.I have inflammatory arthritis in my knee, like rheumatoid arthritis or ankylosing spondylitis.I am currently on hormone replacement therapy.I have moderate knee arthritis as defined by a specific grading system.I have not had joint injections in the last 3 weeks.I have moderate to severe arthritis in my knee.I do not have significant blood, clotting, or nerve disorders.I am taking vitamins/supplements without changing the dose or brand, and they don't contain the same ingredients as in the PRN Joint health formula.I have moderate knee arthritis.I have arthritis in both knees but only one will be part of the study.I do not have allergies to NSAIDs, liver or kidney issues, history of stomach ulcers or bleeding, heart failure, high blood pressure, cancer, or high potassium levels.My knee pain affects my daily activities significantly.I have moderate knee arthritis with symptoms.I can walk 50 feet by myself.I can walk 50 feet by myself.I am scheduled for knee surgery within the next three months.I am between 18 and 90 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Joint Health Product
- Group 2: Placebo
- Group 3: Combination with Omega-3
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Osteoarthritis Patient Testimony for trial: Trial Name: NCT02333084 — Phase 2 & 3
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the age limit for participants in this study over 40 years?
"According to the eligibility requirements posted for this trial, patients must be aged between 18-90. There are currently 39 trials underway for individuals under 18 and 688 trials recruiting seniors."
Answered by AI
Are investigators still seeking participants for this research?
"The listing for this trial on clinicaltrials.gov suggests that patient recruitment is no longer active. The study was first posted online on July 1, 2014 and edited for the last time on August 2, 2016. There are presently 724 other trials seeking participants."
Answered by AI
Might I be a match for this clinical trial's requirements?
"This clinical trial is looking for 120 patients that suffer from arthrosis and meet the following criteria: 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., Age ≥18 and ≤ 90 at the time of informed consent., Subjects with symptomatic moderate arthritis of the knee defined as per, Ability to walk 50 feet unassisted., Lequesne's Functional Index score greater than 7 points."
Answered by AI
Who else is applying?
What state do they live in?
Pennsylvania
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
3+
What site did they apply to?
Rothman Institute
Why did patients apply to this trial?
I've had a knee replacement on the right knee and they say I need it on the left knee however I still receive pain in both knees still and I'm still falling occasionally they said I'm bone on bone in both.
PatientReceived 1 prior treatment
I have a lot of pain in both knees - have been diagnosed with moderate-to-severe arthritis, have tried cortisone & synvisc & suparts, to no avail. Meloxicam is useless. You actually have my x-rays on file at Rothman. I live in NW Philly, and am otherwise in great health. All of these factors motivated me to contact you to express my interest in joining your trial. Thank you.
PatientReceived no prior treatments
What questions have other patients asked about this trial?
How long is the screening process ?
PatientReceived no prior treatments
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