Clinical trial: To Assess the Efficacy of Collagen Supplement in Osteoarthritis (NCT04470336)

Eligibility criteria:
Inclusion Criteria:

          -  Male & female aged ≥ 40 to ≤ 65 years suffering from knee joint pain for at least 3
             months prior to screening.

          -  BMI ≥ 18.5 and ≤ 29.9 kg/m2.

          -  Non-vegetarians (Regardless of whether they eat chicken, fish, goat mutton, pork, beef
             or eggs).

          -  Screening Visual Analogue (VAS) scores for knee joint pain ≥ 60 on a 100-point scale.

          -  Radiographic evidence of grade II/III knee OA based on one of following criteria.

          -  Participants willing to stop the restricted supplements and medications prior to
             inclusion and throughout the study period.

          -  Participants willing to stop any home-based remedies or any other form of topical
             products intended for knee joint pain relief or any other reason for the entire study
             duration.

          -  Willing to stop the use of study designated rescue medication 48 hours prior to all
             assessment visits.

          -  Willing to abstain from food containing type II collagen only from cartilage, e.g.
             chicken, fish, beef, pork, etc. 48 hours prior to all assessment visits.

        Exclusion Criteria:

          -  Prior or ongoing medical conditions (e.g. concomitant illness, psychiatric disorders,
             etc.), abnormal medical history or physical findings.

          -  Participants with history of type II diabetes and uncontrolled hypertension.

          -  Fasting Blood glucose > 125 mg/dl

          -  Systolic blood pressure ≥ 140 mmHg and/or diastolic blood pressure ≥ 90 mmHg.

          -  Radiographic evidence of Grade I or Grade IV OA based on the KL radiographic criteria
             for osteoarthritis.

          -  Any history of trauma, fractures or surgery to the index joint.

          -  Any planned surgery (diagnostic or therapeutic intervention) to the index joint during
             the participation in the study.

          -  Participants with deformity of the knee joint.

          -  Participants with a diagnosed condition which may involve or involves the index joint
             that includes but is not limited to known rheumatic or inflammatory conditions such as
             rheumatoid arthritis, osteomyelitis, osteoporosis, gout, and bone metastasis.

          -  Other pathologic lesions on X-rays of the knee.

          -  Current smokers or chronic alcoholics
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 40 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