Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2025-12-25 @ 1:22 AM
NCT ID:
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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
80 Years
Study:
NCT01836393
Study Brief:
Protocol Section:
NCT01836393