Clinical trial: Effects of Aquamin F on Osteoarthritis of the Knee (NCT00452101)

Eligibility criteria:
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 Rheumatology17, 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 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 clinic evaluations every four weeks.

          -  Subjects who are willing to stop taking calcium supplements, if any, and to restrict
             consumption of high calcium foods to 600 mg (two dairy serving) 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 unauthorized supplements or
             participating in any other clinical trial or experimental treatment during this trial

          -  Subjects with normal gastrointestinal digestion and absorption.

        Exclusion Criteria

          -  Subjects suffering from 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:

               -  Non-Steroidal Anti-Inflammatory Drugs (NSAIDS) within 48 hours prior to study
                  enrollment.

               -  Intramuscular or systemic corticosteroid injection within 4 weeks prior to study
                  enrollment.

               -  Intra-articular corticosteroid injection within 2 months prior to study
                  enrollment.

               -  Intra-articular hyaluronic acid injection within 4 months prior to study
                  enrollment.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 35 Years old.
Subject must be at most 75 Years

Patient description (medical language): A 66-year-old woman comes to the office due to joint pain in the hands and periodic morning stiffness that lasts less than 15 minutes.  The pain is moderately severe and worsens with daily activity. The patient used Tylenol with minimal relief.  Past medical history is notable for hypertension and hypercholesteremia.  Physical examination shows firm nodules over the distal interphalangeal joints, bilaterally. The patient has pain in her knees as well. The knees are stiff in the morning for less than 30 minutes and become worse with climbing stairs. She has some sensation of bone friction during activity. X-ray shows narrowing of the joint space, subchondral bone sclerosis and osteophyte formation along the joints.

Patient description (patient's own words): I'm a 66-year-old woman and I went to my doctor's office because of a bloody joint pain in my hands that has been lasting for a while. The pain comes and go in the morning usually. I feel like a stiffness that last less than 15 minutes. The pain is moderately severe but it gets worse when I'm using my hands. I used Tylenol which helped a little. Apart from that, I suffer from hypertension and high cholesterol. The doctor made me notice that I have bumps around both of my hand joints. I also suffer from my knees and they are also stiff in the morning for around 30 min. It's even worse when I climb up the stairs! I also feel like my bones are rubbing against each other when I'm moving. The X-ray showed that I have narrow joint space, I have sclerosis, and abnormal growths of bone along my joints.

Does the patient match the trial criteria? 1