Inclusion criteria All Fulfill
Item
subjects eligible for enrollment in the study met all of the following criteria:
boolean
C1512693 (UMLS CUI [1,1])
C0444868 (UMLS CUI [1,2])
C1550543 (UMLS CUI [1,3])
Informed Consent | Protocol Compliance
Item
1. subjects who are capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
boolean
C0021430 (UMLS CUI [1])
C0525058 (UMLS CUI [2])
Ambulatory | Gender | Pregnancy Absent | Age
Item
2. ambulatory nom pregnant females and males 40-<80 years of age.
boolean
C1561561 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
C0032961 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0001779 (UMLS CUI [4])
Analgesics Withdrawn | Dietary Supplements Withdrawn | Symptom relief Knee Osteoarthritis
Item
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.
boolean
C0002771 (UMLS CUI [1,1])
C2349954 (UMLS CUI [1,2])
C0242295 (UMLS CUI [2,1])
C2349954 (UMLS CUI [2,2])
C1457887 (UMLS CUI [3,1])
C0564405 (UMLS CUI [3,2])
C0409959 (UMLS CUI [3,3])
Pain Visual Analog Pain Scale | Pain Knee Affected
Item
4. pain at or below 80 mm on a 100 mm vas in the index knee.
boolean
C0030193 (UMLS CUI [1,1])
C0042815 (UMLS CUI [1,2])
C0030193 (UMLS CUI [2,1])
C0022742 (UMLS CUI [2,2])
C0392760 (UMLS CUI [2,3])
Osteoarthritis, Knee | Idiopathic osteoarthritis ACR Criteria | Knee X-Ray Computed Tomography | Knee pain Visual Analog Pain Scale
Item
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).
boolean
C0409959 (UMLS CUI [1])
C0409952 (UMLS CUI [2,1])
C3273747 (UMLS CUI [2,2])
C0022742 (UMLS CUI [3,1])
C0040405 (UMLS CUI [3,2])
C0231749 (UMLS CUI [4,1])
C0042815 (UMLS CUI [4,2])
Knee Osteoarthritis Kellgren-Lawrence score Radiography
Item
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)
boolean
C0409959 (UMLS CUI [1,1])
C3177117 (UMLS CUI [1,2])
C0034571 (UMLS CUI [1,3])
Joint space Width Minimum | Medial compartment of knee | Lateral compartment of knee | Radiography Metatarsophalangeal joint
Item
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.
boolean
C0224497 (UMLS CUI [1,1])
C0487742 (UMLS CUI [1,2])
C1524031 (UMLS CUI [1,3])
C0447799 (UMLS CUI [2])
C0447800 (UMLS CUI [3])
C0034571 (UMLS CUI [4,1])
C0025589 (UMLS CUI [4,2])
Exclusion Criteria Any Fulfill
Item
subjects with any of the following criteria must not be enrolled in the study:
boolean
C0680251 (UMLS CUI [1,1])
C1552551 (UMLS CUI [1,2])
C1550543 (UMLS CUI [1,3])
Hypersensitivity Zingiber montanum
Item
1. subjects with history of hypersensitivity to plai.
boolean
C0020517 (UMLS CUI [1,1])
C1891634 (UMLS CUI [1,2])
Skin lesion Knee Affected
Item
2. subjects with skin lesion at the index knee.
boolean
C0037284 (UMLS CUI [1,1])
C0022742 (UMLS CUI [1,2])
C0392760 (UMLS CUI [1,3])
Surgical procedure on lower extremity
Item
3. a history of lower extremity surgery within 6 months prior to screening.
boolean
C0187763 (UMLS CUI [1])
Injury Knee Affected
Item
4. significant prior injury to the index knee within 12 months prior to screening
boolean
C3263723 (UMLS CUI [1,1])
C0022742 (UMLS CUI [1,2])
C0392760 (UMLS CUI [1,3])
Spinal Disease Affecting Knee | Disease Lower extremity joint Affecting Knee
Item
5. disease of the spine or other lower extremity joints of sufficient degree to affect the index knee.
boolean
C0037933 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0022742 (UMLS CUI [1,3])
C0012634 (UMLS CUI [2,1])
C0584731 (UMLS CUI [2,2])
C0392760 (UMLS CUI [2,3])
C0022742 (UMLS CUI [2,4])
Pharmaceutical Preparations Affecting Bone metabolism | Pharmaceutical Preparations Affecting Cartilage metabolism
Item
6. treatment with other drugs potentially affecting bone or cartilage metabolism as described below:
boolean
C0013227 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0596204 (UMLS CUI [1,3])
C0013227 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C0596276 (UMLS CUI [2,3])
CORTICOSTEROIDS FOR SYSTEMIC USE chronic
Item
chronic systematic corticosteroids
boolean
C3653708 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
Hyaluronic Acid Injection | Knee Affected
Item
hyaluronan injection into the index knee with in the previous 6 months.
boolean
C0020196 (UMLS CUI [1,1])
C1828121 (UMLS CUI [1,2])
C0022742 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
diacerein | Glucosamine
Item
diacerin or glucosamine treatment within the last 12 months.
boolean
C0057678 (UMLS CUI [1])
C0017718 (UMLS CUI [2])