Clinical trial: Influence of Instaflex Advanced Supplement on Joint Function (NCT03041077)

Eligibility criteria:
Inclusion Criteria:

          -  Male or female adult

          -  Age 50-75 years

          -  Self-reported history (>3 months) of joint discomfort in the knees. NOTE: the severity
             of knee discomfort will be determined through a questionnaire called the WOMAC, and
             should be at least 2 points (indicating mild knee discomfort or greater).

          -  No history of regular use of non-steroidal anti-inflammatory drugs (NSAIDs) use (e.g.,
             ibuprofen, aspirin) during the previous two weeks, and willingness to avoid the use of
             NSAIDs during the 12-week study.

          -  Not on other medications (e.g., analgesic gels, arthritis medications, other
             anti-inflammatory drugs) or supplements (in particular, glucosamine and chondroitin)
             for joint discomfort during the previous two weeks, and a willingness to avoid use of
             these during the 12-week study.

          -  No serious medical problems (current cancer case, severe rheumatoid arthritis, recent
             heart attack, recent stroke, congestive heart failure, ulcers, kidney disease, or
             other disease that would interfere with study participation).

          -  No psychiatric disorder or other condition that might interfere with self-assessment
             ability.

          -  Willingness to follow all study procedures including randomization to one of two
             groups, and to stay weight stable during the study.

        Exclusion Criteria:

          -  Inability to comply with study requirements including avoidance of NSAIDs, other
             anti-inflammatory medications, or discomfort supplements.

          -  Current diagnosis of cardiovascular disease, cancer (except for non-melanoma skin
             cancer), severe rheumatoid arthritis, ulcers, kidney disease, psychiatric disorder.

          -  For female subjects: Pregnant or nursing, or planning to be pregnant or nursing during
             the study.

          -  On a weight loss program during the study.

          -  Vegetarian or vegan.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 50 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? Entailment