Clinical trial: Efficacy Study on Symptomatic Control of Patient With Knee Osteoarthritis Between 14% of Plai (Plaivana®) to Placebo Gels (NCT01836393)

Eligibility criteria:
Inclusion Criteria:

        Subjects eligible for enrollment in the study met all of the following criteria:

          1. Subjects who are capable of giving written informed consent, which includes compliance
             with the requirements and restrictions listed in the consent form.

          2. Ambulatory nom pregnant females and males 40-<80 years of age.

          3. Subjects who withdraw pain medication or nutritional supplements for symptom relief
             for knee OA for a total of at least 15 days before screening.

          4. Pain at or below 80 mm on a 100 mm VAS in the index knee.

          5. A documented diagnosis of OA of the knee, or meeting American College of Rheumatology
             (ACR) clinical criteria for classification of idiopathic (primary) OA for at least 6
             months prior to screening. If OA is presented in both knees the investigator will
             identify which knee will be X-rayed for study entry, with preference for the knee with
             more severe pain (<80mm VAS).

          6. Has documented radiographic evidence of OA of the knee from the screening Visit
             radiograph of grade 2 or 3 according to Kellgren and Lawrence Radiographic Grading
             (11)

          7. Subjects with baseline minimum joint space width in the medial and lateral
             compartments of the index knee of > 1.5 mm and > 2.5 mm at Baseline respectively,
             measured from radiographs using the MTP view.

        Exclusion Criteria

        Subjects with any of the following criteria must not be enrolled in the study:

          1. Subjects with history of hypersensitivity to Plai.

          2. Subjects with skin lesion at the index knee.

          3. A history of lower extremity surgery within 6 months prior to screening.

          4. Significant prior injury to the index knee within 12 months prior to screening

          5. Disease of the spine or other lower extremity joints of sufficient degree to affect
             the index knee.

          6. Treatment with other drugs potentially affecting bone or cartilage metabolism as
             described below:

               -  chronic systematic corticosteroids

               -  hyaluronan injection into the index knee with in the previous 6 months.

               -  Diacerin or Glucosamine treatment within the last 12 months.
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 80 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? Entailment