Clinical trial: Multi-center Clinical Study of Guli Capsules in the Treatment of Knee Osteoarthritis (NCT02484508)

Eligibility criteria:
Inclusion Criteria:

          -  Ages between 40 and 70 years, both gender

          -  Kellgren and Lawrence grades of I to III;

          -  The subjects volunteered participate in the study and complied with the regulations
             and signed the written consent voluntarily.

          -  Meet the following clinical and radiological criteria for diagnosis:

          -  Clinical criteria:

               1. most of the time have knee pain nearly a month

               2. bone fricative

               3. morning stiffness is less than or equal to 30 min

               4. age is more than or equal to 38 years

               5. bony enlargement. Who meet (1) + (2) or (1) + (4) + (5) can be diagnosed as knee
                  osteoarthritis.

          -  Radiological criteria:

               1. most of the time have knee pain nearly a month

               2. the X-ray showed osteophyte formation

               3. joint fluid examination confirmed with osteoarthritis

               4. age is more than or equal to 40 years

               5. morning stiffness is less than or equal to 30 min

               6. bone fricative. Meet (1) + (2) or (1) + (3) + (5) + (6) or (1) + (4) + (5) + (6).

        Exclusion Criteria:

          -  Patient with a history of allergy to similar constituents or chemical components of
             the drug;

          -  Patients with limited liver and kidney function;

          -  Patients with hematopoietic system disease;

          -  Patients with diabetes, Cushing's syndrome and other endocrine disorders;

          -  Patients with severe heart and brain disease;

          -  Patients with low immunity;

          -  Patients directly involved with the staff in the study;

          -  Women during pregnancy or lactation;

          -  Participating in other clinical studies or Participated in 3 months;

          -  The investigators judged who be unfit for the study.
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 70 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? Entailment