Effects of Aquamin F on NSAID Dose Reduction in Osteoarthritis of the Knee

This is an interventional treatment trial for Osteoarthritis of the Knee focused on measuring Osteoarthritis, Clinical trial, Aquamin F, NSAID Read More

Inclusion Criteria:

• Subjects aged 35 to 75, male or female
• Subjects diagnosed with symptomatic moderate to severe osteoarthritis of the knee according to the modified criteria of the American College of Rheumatology 17,18
• Subjects who present with osteoarthritis of the knee as judged by symptoms and disabilities detectable through published, validated questionnaires or previous diagnosis by a physician
• subjects who are symptomatic with daily or near daily pain and stiffness from osteoarthritis
• subjects who are taking non-steroidal anti-inflammatory drugs (NSAIDs) prior to study enrollment
• subjects who are willing to stop NSAIDS and use acetaminophen for pain management during the trial
• subjects with screening WOMAC osteoarthritis index total score (transformed score) of not more than 75
• subjects with ability to comprehend and complete the questionnaires and forms
• subjects whose schedules permit clinical evaluations every four weeks
• subjects who are willing to stop taking calcium supplements, if any and to restrict consumption of high calcium food to 600mg (two dairy servings) per day
• subjects with a high probability of compliance with study procedures and test article consumption
• subjects willing and able to follow protocol guidelines and schedules and complete diaries
• subjects who are likely to abstain from taking unathorized supplements or participating in any other clinical trial or experimental treatment during this trial
• subjects with normal gastrointestinal digestion and absorption

Exclusion Criteria:

• subjects who have a history of inflammatory arthritis, gout, pseudogout, Paget's disease, seizure disorder, insulin dependent diabetes mellitus, uncontrolled hypertension, unstable cardiovascular disease, active hepatic or renal disease, active cancer and/or HIV infection
• subjects who are non-ambulatory or bedridden due to osteoarthritis
• subjects who are dependent on prescription drugs to control pain
• subjects on any other clinical trial or experimental treatment in the past 3 months
• subjects who are pregnant, lactating or at risk of becoming pregnant
• subjects who have received : intramuscular corticosteroid injection or systemic corticosteroid administration within 4 weeks prior to study enrollment, intra-articular corticosteroid injection within 2 months prior to study enrollment or intra-articular hyaluronic acid injection within 4 months prior to study enrollment.