Tong-Luo-Qu-Tong Plaster for KOA: a Randomised, Double-blind, Parallel Positive Control, Multi-center Clinical Trial

Inclusion Criteria: * Participants who have symptomatic knee osteoarthritis, diagnosis of KOA was based on criteria developed by the American College of Rheumatology(ACR) in 1986 * The differentiation standard of the arthralgia syndrome of traditional Chinese medicine(TCM): Referring to the Guidelines on the clinical research of Chinese medicine new drugs(2002) * The visual analog scale score is no less than 30 mm. * The patient is older than or equal to 40 years old * All the patients signed informed consent form before study begins Exclusion Criteria: * Hormone therapy was used in the first month of screening * Arthroscopy and intra-articular injection was performed on the knee joint which is going to be evalued during the first three months of screening. * There is a history of trauma or surgery in the knee joint six months before screening or participants who a history of lessmore than three trauma or surgical procedures in the knees * Participants who have knee arthroplasty, lumbar spinal stenosis, ankylosing spondylitis, rheumatic arthritis, rheumatoid factor positive(\>40), eallergic constitution and mental disorder will be excluded from the trial * Patients has severe diseases and complications such as severe diabetes, serious liver and kidney disease, malignant tumors, infectious diseases or complications affecting the knee joints * Pregnant,lactating women * Subjects are participating in or have participated in other clinical trials in the first three months. * Subjects cannot stop using the drugs immediately with a long-term use of other related drugs. * Combined with severe primary diseases such as hepatic renal functionand hematopoietic system, such as liver function (ALT≧1.5×ULN), and kidney function(AST≧1.5×ULN)