Osteoarthritis
Conditions
Brief summary
safety, efficacy and acceptability of Flavocoxid
Detailed description
Safety, Efficacy and acceptability of Flavocoxid (Limbrel) compared with Naproxen in Subjects with Osteoarthritis of the Knee. A Pilot Study
Interventions
DIETARY_SUPPLEMENTflavocoxid
flavonoid mixture
DRUGNaproxen
non-steroidal anti-inflammatory drug
Sponsors
Primus Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
OA of the knee,K-L grade 2-3 in general good health is currently taking an NSAID or COX-2 inhibitor -
Exclusion criteria
pregant or nursing women grade 1 or 4 OA any significant medical condition that in the opinion of the physician might put the subject at risk in this study any form of arthropathy other than OA any condition that might confound the evaluation of the pain, stiffness or function of the target joint intra-articular cotticosteroid inkection in the target joint within 3 month of the screening visit concomitant use of other anti-inflammatory or anti arthritic medication or products(including OTC and herbal preparations) Low dose aspirin for cardio-protection is allowed concomitant use of coumadin or other anticoagulant or anti-platelet medication concomitant use of gastro-protectiv medications including, but not limited to, H2 blockers and proton pump inhibitors, including OTC and herbal products History of allergy to Flavonoids \-
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| compare efficacy | — |
Secondary
| Measure | Time frame |
|---|---|
| evaluate safety | — |
Countries
United States
Outcome results
None listed