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 47-year-old woman comes to the office complaining of pain in the calf and knee when she bends down. The pain limits her activity. Her medical history is significant for osteoarthritis, for which she uses nonsteroidal anti-inflammatory drugs (NSAIDs) for the past two years. She is living with her husband and has 3 children. She doesn't smoke but drinks alcohol occasionally. Her vital signs are normal. On physical examination, there is a small effusion in the right knee. The effusion grew a little larger and she developed a tender swelling in the popliteal fossa and calf. Both the pain and swelling worsened as she bent and straightened her knee.

Patient description (patient's own words): I'm a 47-year-old woman, married with 3 kids. I don't smoke and I drink occasionally. I went to the doctor because of pain in my calf and knee when I was bending down. This has been limiting my daily activities. I have been diagnosed with osteoarthritis for which I have taken anti-inflammatory drugs for the past 2 years. The doctor saw a small fluid buildup in my right knee. This buildup became a bit bigger and I have a swollen calf. The pain is worse when I bend and straighten my knee.

Does the patient match the trial criteria? Entailment