NCT02333084UnknownPhase 2
The Influence Of a Natural Anti-Inflammatory Product On Levels Of Inflammatory Markers In Cases With Osteoarthritis Of Knee
Physician Recommended Nutriceuticals1 site in 1 country120 target enrollmentStarted: July 1, 2014Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 2
- Sponsor
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Human Inflammation Multi analyte profile (MAP) v1.0 in Synovial fluid and blood
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Joint Health Product
Experimental
natural dietary supplement
Intervention: PRN Joint Health Formula (Dietary Supplement)
Placebo
Placebo Comparator
vegetable oil placebo
Intervention: placebo (Dietary Supplement)
Combination with Omega-3
Active Comparator
combination with omega-3 fish oil
Intervention: PRN Flex Omega Benefits® combination (Dietary Supplement)
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)(12 weeks)
- Pain scores on Visual analog scale(12 weeks)
Investigators
Study Sites (1)
Loading locations...
Similar Trials
Completed
Phase 3
Delivra Joint Health Cream In The Treatment Of Pain Caused By Osteoarthritis Of The KneeOsteoarthritisNCT02193711Delivra, Inc.160
Completed
Not Applicable
Pilot study to investigate the anti-inflammatory effects of caffeine in subjects with chronic obstructive pulmonary disease (COPD)chronic inflammationchronic obstructive pulmonary disease (COPD)10038716NL-OMON31548Technologiestichting STW (NWO)12
Completed
Phase 1
Phase I Study to Assess Safety and Pharmacokinetics of GMI-1271 in Healthy Adult SubjectsHealthy VolunteersNCT02271113GlycoMimetics Incorporated32
Recruiting
Early Phase 1
A Mechanistic Clinical Trial of Colchicine in Patients Undergoing Femoral EndarterectomyPeripheral Artery DiseaseNCT06212271University of Pennsylvania24
Withdrawn
Phase 1
This Study is to Evaluate the Safety and Pharmacokinetics of SBS-101 in Patients With Oral Premalignant LesionsLeukoplakia, OralNCT03939364Skyline Biosciences