OsteoarthritisPhase 2/3NCT02333084
The Influence Of a Natural Anti-Inflammatory Product On Levels Of Inflammatory Markers In Cases With Osteoarthritis Of Knee
A Phase 2/3 study testing PRN Joint Health Formula and PRN Flex Omega Benefits® combination in people with Osteoarthritis, run by Physician Recommended Nutriceuticals at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- PRN Joint Health Formula and PRN Flex Omega Benefits® combination
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2014to Jul 2017
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 11Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Osteoarthritis
- Being tested
- PRN Joint Health Formula, placebo, PRN Flex Omega Benefits® combination
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRN Joint Health FormulaDietary supplement
placeboDietary supplement
PRN Flex Omega Benefits® combinationDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Joint Health Product | Experimental | natural dietary supplement Receives: Dietary Supplement: PRN Joint Health Formula |
| Placebo | Placebo comparator | vegetable oil placebo Receives: Dietary Supplement: placebo |
| Combination with Omega-3 | Active comparator | combination with omega-3 fish oil Receives: Dietary Supplement: PRN Flex Omega Benefits® combination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Human Inflammation Multi analyte profile (MAP) v1.0 in Synovial fluid and blood
46 different markers of inaflammation will be studies
Measured: 12 weeks
Secondary outcomes (2)
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Measured: 12 weeks
Pain scores on Visual analog scale
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2015 (estimated)
- Study startJul 2014
- Primary completionJul 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Physician Recommended Nutriceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Rothman Institute Orthopedics
- Responsible party
- Sponsor
- Investigators
- Javad Parvizi, MD, Principal investigator, Rothman Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02333084
- Sponsor's protocol ID
- PRN 20141
- Status last verified
- Aug 2016
- First submitted
- 6 Oct 2014
- Last updated
- 4 Aug 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence Of a Natural Anti-Inflammatory Product On Levels Of Inflammatory Markers In Cases With Osteoarthritis Of Knee
- ClinicalTrials.gov ID
- NCT02333084
- Acronym / sponsor ID
- PRN 20141
- Conditions
- Osteoarthritis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Physician Recommended NutriceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- Rothman Institute Orthopedics
- Study start
- Jul 2014
- Primary completion
- Jul 2017 (estimated)
- First posted
- 7 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Joint Health Product | Experimental | Dietary Supplement: PRN Joint Health Formulanatural dietary supplement |
| Placebo | Placebo comparator | Dietary Supplement: placebovegetable oil placebo |
| Combination with Omega-3 | Active comparator | Dietary Supplement: PRN Flex Omega Benefits® combinationcombination with omega-3 fish oil |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PRN Joint Health Formula | Dietary supplement | Joint Health Product |
| placebo | Dietary supplement | Placebo |
| PRN Flex Omega Benefits® combination | Dietary supplement | Combination with Omega-3 |
Primary outcome
Human Inflammation Multi analyte profile (MAP) v1.0 in Synovial fluid and blood
Time frame: 12 weeks
46 different markers of inaflammation will be studies
2 secondary outcomes
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time frame: 12 weeks
Pain scores on Visual analog scale
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2016.
Related trials for Osteoarthritis
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Active, not recruiting
Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
Osteoarthritis (OA) of the Hip
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Javad Parvizi, MD principal investigator
Rothman Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing PRN Joint Health Formula and PRN Flex Omega Benefits® combination in people with Osteoarthritis, run by Physician Recommended Nutriceuticals at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Human Inflammation Multi analyte profile (MAP) v1.0 in Synovial fluid and blood (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2016.