Clinical trial: Tong-Luo-Qu-Tong Plaster for KOA: a Randomised, Double-blind, Parallel Positive Control, Multi-center Clinical Trial (NCT03309501)

Eligibility criteria:
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)
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 75 Years

Patient description (medical language): A 66-year-old woman comes to the office due to joint pain in the hands and periodic morning stiffness that lasts less than 15 minutes.  The pain is moderately severe and worsens with daily activity. The patient used Tylenol with minimal relief.  Past medical history is notable for hypertension and hypercholesteremia.  Physical examination shows firm nodules over the distal interphalangeal joints, bilaterally. The patient has pain in her knees as well. The knees are stiff in the morning for less than 30 minutes and become worse with climbing stairs. She has some sensation of bone friction during activity. X-ray shows narrowing of the joint space, subchondral bone sclerosis and osteophyte formation along the joints.

Patient description (patient's own words): I'm a 66-year-old woman and I went to my doctor's office because of a bloody joint pain in my hands that has been lasting for a while. The pain comes and go in the morning usually. I feel like a stiffness that last less than 15 minutes. The pain is moderately severe but it gets worse when I'm using my hands. I used Tylenol which helped a little. Apart from that, I suffer from hypertension and high cholesterol. The doctor made me notice that I have bumps around both of my hand joints. I also suffer from my knees and they are also stiff in the morning for around 30 min. It's even worse when I climb up the stairs! I also feel like my bones are rubbing against each other when I'm moving. The X-ray showed that I have narrow joint space, I have sclerosis, and abnormal growths of bone along my joints.

Does the patient match the trial criteria? 1