Knee osteoarthritis
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. According with the diagnostic criteria for knee osteoarthritis in the Guidelines for the Diagnosis and Treatment of Osteoarthritis (2018) : (1) Recurring persistent knee pain in the past month; (2) Radiographs (standing or weight-bearing position) showed joint space narrowing, subchondral osteosclerosis and/or cystic change, and osteophyte formation at the joint margin; (3) Over 50 years old; (4) Morning stiffness less than 30mins; (5) Bone rubbing sensation during activities; 1 plus (any two of 2, 3, 4 or 5) can be diagnosed as knee osteoarthritis; 2. Aged 40-75 years old, no gender prefepreference; 3. The subject is informed and voluntarily sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients suffered from immune diseases or other diseases that interfere with the efficacy indicators of this study: other inflammatory diseases of the knee joint, such as rheumatoid arthritis, psoriatic arthritis, gout, tumor, chorionodular synovitis, joint trauma, suppurative arthritis, tuberculosis arthritis; Osteoarthritis caused by osteomyelitis, bone tumor and bone tuberculosis; the suppurative, non-specific and other infectious knee arthritis; 2. Patients had severe cardiovascular and cerebrovascular diseases (such as myocardial infarction, stroke, etc.), blood system (such as bleeding tendency, coagulopathy, etc.), liver, gastrointestinal, kidney diseases, and diabetes that could be judged whether affect the efficacy and safety of the experimental drugs or not by the investigators; 3. mental illiness patients; 4. Patients with systemic infection or during infectious disease treatment at the time of screening; 5. Patients who had used NSAIDS, benzothiazines, glucosamine, chondroitin sulfate, or other medicines for the treatment of knee osteoarthritis or similar Chinese medicines used to tonify liver and kidney, strengthen muscles and bones, remove wind and dampness, and clear meridians and collaterals within 2 weeks before screening; 6. Long-term use of other drugs that affect the efficacy and safety of test medicines and comprehensive treatment; 7. Lactating or pregnant women or women in childbearing age who were planning pregnancy; 8. Patient who were susceptible or were allergic to the components of the study medicines 9. The researchers believe that the candidates should not be included in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Western Ontario and McMaster universities osteoarthritis (WOMAC) index; | — |
Secondary
| Measure | Time frame |
|---|---|
| Visual Analogue Scale/Score, VAS;Lequesne;physician global assessment, PHGA; | — |
Countries
China
Contacts
Affiliated Hospital of North Sichuan Medical College