Clinical trial: Assessment of the Efficacy of ParActin® in Subjects With Mild to Moderate Osteoarthritis (NCT03262792)

Eligibility criteria:
Inclusion Criteria:

          1. Male or female subjects in the age range of 40 - 70 years (both inclusive).

          2. Body mass index (BMI) must be ≥ 25 and < 29.9 kg/m2.

          3. Radiographic evidence of grade I- II osteoarthritis of knee joint, based on the
             Kellgren and Lawrence radiographic entry criteria with WOMAC pain score in range of
             10-16.

          4. History of primary idiopathic osteoarthritis of the knee characterized by pain of mild
             to moderate intensity which requires intake of analgesics.

          5. Self-reported difficulty in at least one of the following activities attributed to
             knee pain: walking a distance of 400 metres, getting in and out of the car, going up
             and down the stairs or stiffness observed in the knee if > 30 minutes in the same
             position.

          6. Female subjects of child-bearing age must be willing to use the accepted methods of
             contraception during the course of the study.

          7. Ability to provide written informed consent.

        Exclusion Criteria:

          1. Prior or ongoing medical conditions (e.g. concomitant illness, psychiatric condition,
             alcoholism, drug abuse), medical history, physical findings, ECG findings or
             laboratory abnormalities that in the investigator's opinion could adversely affect the
             safety of the subject, makes it unlikely that the course of treatment or follow-up
             would be completed or could impair the assessment of study results.

          2. History of surgery or major trauma to the study joint.

          3. History of arthroscopic surgery or intervention on the study joint.

          4. Subjects who have received intra-articular steroids or hyaluronic acid within the last
             three months.

          5. Signs of active study joint inflammation including redness, warmth, and/or, if
             qualifying with osteoarthritis of the knee, a large, bulging effusion of the study
             knee joint with the loss of normal contour of the joint at the screening visit or at
             the baseline examination after the washout period.

          6. Subjects awaiting a replacement of knee or hip joint.

          7. Subjects with other conditions that cause pain.

          8. Subjects with deformity of the knee joint.

          9. Subject who are significantly incapacitated or disabled and would be categorized as
             ACR Functional Class IV (largely or wholly incapacitated), or unable to walk without
             assistive devices.

         10. Subjects with other known rheumatic or inflammatory disease such as rheumatoid
             arthritis, osteomyelitis and bone metastasis.

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

         12. Positive hepatitis B surface antigen, Hepatitis C antibody, Anti human
             immunodeficiency virus (HIV) antibody test, or VDRL.

         13. History of bleeding disorders.

         14. Inability to comply with the protocol requirements.

         15. Participation in any other clinical trial within 3 months of registering in this
             trial.

         16. Women of child-bearing potential with a positive pregnancy test or who are lactating.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 40 Years old.
Subject must be at most 70 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