Clinical trial: A Study to Determine if Aquamin Modulates Inflammatory Biomarkers in the Blood of Osteoarthritis and Healthy Subjects (NCT01321281)

Eligibility criteria:
Inclusion Criteria:

        To be considered eligible for enrollment into the study, subjects must;

          -  Be able to give written informed consent.

          -  Be female and between 18 and 65 years of age.

          -  Be a non-pregnant female.

          -  Be in generally good health as determined by the investigator.

          -  Osteoarthritis patients must have a clinical diagnosis of moderate to severe
             osteoarthritis.

        Exclusion Criteria:

        Subjects will be excluded from the study if they meet any of the below criteria;

          -  Are less than 18 and greater than 65 years of age.

          -  Are pregnant females.

          -  Are currently taking probiotics or vitamin supplements, or have taken them in the past
             14 days.

          -  Have a significant acute or chronic coexisting illness (cardiovascular,
             gastrointestinal, endocrinological, immunological, metabolic or any condition which
             contraindicates, in the investigators judgment, entry to the study).

          -  Having a condition or taking a medication that the investigator believes would
             interfere with the objectives of the study, pose a safety risk or confound the
             interpretation of the study results; to include non-steroidal anti-inflammatory drugs
             (NSAIDs), steroids and vitamin.

          -  Individuals who, in the opinion of the investigator, are considered to be poor
             attendees or unlikely for any reason to be able to comply with the trial.

          -  Subjects may not be receiving treatment involving experimental drugs.

          -  If the subject has been in a recent experimental trial, these must have been completed
             not less than 30 days prior to this study.

          -  Have a malignant disease or any concomitant end-stage organ disease.
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 65 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? Contradiction