Clinical trial: A Controlled Study of an Herbal Topical Patch in Treating Osteoarthritis (OA) of the Knee (NCT01183624)

Eligibility criteria:
Inclusion Criteria:

          -  Male or female between 40 and 70 years of age

          -  Medically cleared to participate by a site affiliated physician following a physical

          -  History of, or current diagnosis of, OA of the knee

          -  Evidence of idiopathic OA of at least one knee

          -  Subject Assessment of OA pain in target knee 40 - 75 mm (on the 100 mm VAS inclusive)
             in the index knee, on the WOMAC Pain composite subscale at Visit 1

          -  Subject Assessment of OA pain in non-index knee (if applicable) is ≤ 20mm

          -  Subject Global Assessment of OA Condition (5 pt categorical scale, 1 = very good to 5
             = very poor) of grade 3-5 (i.e. fair, poor or very poor)

          -  Evidence of idiopathic OA of at least one knee as defined by the American College of
             Rheumatology Classification (ACR) of OA of the Knee

        Exclusion Criteria:

          -  Grade 1 or Grade 4 severity of the index knee based on the Kellgren and Lawrence
             radiographic criteria

          -  Pain greater than 20 mm on the VAS in the non-index knee (either at rest or with
             movement)

          -  Prior injection or arthroscopy of study knee within 3 months

          -  Crystalline-induced synovitis (e.g. gout, pseudo gout, nonsteroid arthritis,
             hydroxyapatite deposit), acute inflammatory arthritis, rheumatoid arthritis, psoriatic
             arthritis, septic arthritis, fibromyalgia, systemic lupus, erythematosus collagen
             vascular disease or other types of inflammatory arthritis in the index knee

          -  Pain in either knee is of neurological origin

          -  An injury or surgery to the same body region within the prior 6 months or a lifetime
             history of 3 or more injuries/surgeries to the injured body region

          -  Signs of clinically important active inflammation of the study knee joint including
             redness, warmth, and/or a large, bulging effusion with the loss of normal contour at
             the screening and/or baseline visits

          -  Other criteria that - in the opinion of the investigator - may jeopardize the safety
             of the subject or the study results.
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 47-year-old woman comes to the office complaining of pain in the calf and knee when she bends down. The pain limits her activity. Her medical history is significant for osteoarthritis, for which she uses nonsteroidal anti-inflammatory drugs (NSAIDs) for the past two years. She is living with her husband and has 3 children. She doesn't smoke but drinks alcohol occasionally. Her vital signs are normal. On physical examination, there is a small effusion in the right knee. The effusion grew a little larger and she developed a tender swelling in the popliteal fossa and calf. Both the pain and swelling worsened as she bent and straightened her knee.

Patient description (patient's own words): I'm a 47-year-old woman, married with 3 kids. I don't smoke and I drink occasionally. I went to the doctor because of pain in my calf and knee when I was bending down. This has been limiting my daily activities. I have been diagnosed with osteoarthritis for which I have taken anti-inflammatory drugs for the past 2 years. The doctor saw a small fluid buildup in my right knee. This buildup became a bit bigger and I have a swollen calf. The pain is worse when I bend and straighten my knee.

Does the patient match the trial criteria? 1