Knee Osteoarthritis
Conditions
Interventions
intervention group:background treatment, joint cavity sodium hyaluronate injection and Tripterygium wilfordii Hook F
control group:background treatment and joint cavity sodium hyaluronate injection
Sponsors
Beijing Hospital
Eligibility
Sex/Gender
All
Age
45 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1)either gender with age 45-75; (2)classified as KOA according to the classification criteria established by the American College of Rheumatology (ACR) in 1986; (3)Knee pain score =4 in the past week; (4)X-ray classification of KOA lesions (K-L Grade II-III); (5)A physical examination of the knee suggests the presence of arthritis with at least two of the following characteristics: local joint swelling, tenderness, elevated skin temperature, and the presence of joint effusion; (6)Good compliance, can sign informed consent.
Exclusion criteria
Exclusion criteria: (1)Combined with other types of arthritis (including but not limited to, gout arthritis, rheumatoid arthritis, reactive arthritis, psoriatic arthritis, sero-negative spondyloarthropathy, systemic lupus erythematosus, inflammatory myopathy, undifferentiated connective tissue disease, etc.); (2)Pain relievers such as NSAIDs were needed at least 50% of the time in the past 2 months; (3)Drugs such as NSAIDs or Tramadol hydrochloride sustained release tablets that affect pain assessment were used during the first 5 drug half-lives or within 72 hours (depending on the longer time); (4)Regular use of topical medications to relieve knee pain and reluctance to stop; (5)BMI>30Kg/m2; (6)In the past 3 months, he has received injections of sodium hyaluronate, hyaluronic acid or glucocorticoid in the articular cavity; (7)Had arthroscopy of the knee within 12 months, or had planned to have artificial knee replacement for KOA; (8)Received other immunosuppressive drugs within 3 months (including but not limited to glucocorticoids, hydroxychloroquine, methotrexate, sulfasalazine, tacrolimus, cyclophosphamide, rituximab, infliximab, tofaciib, baritinib, etc.); (9)Hematological diseases such as myelodysplastic syndrome, paroxysmal sleep hemoglobinuria, aplastic anemia, leukemia, lymphoma, myelofibrosis, etc. or solid tumor; (10)HIV/HBV/HCV infection, present TB infection or TB activity, or concomitant other present active infections (sepsis, pneumonia, abscess, etc.); (11)Are pregnant, breastfeeding, or still planning to become pregnant, or cannot accept the potential reproductive toxic side effects of tripterygium wilfordii; (12)Uncontrolled hypertension, diabetes (HbA1c =8%); (13)WBC1.5 ULNALT/AST/ALP>3ULNTbil/Dbil>2ULN; (14)Severe visceral insufficiency, or the presence of uncontrolled or unstable chronic disease; (15)Do not receive knee cavity drug injection therapy or knee cavity injection is contraindicated or failure to follow up regularly according to the study protocol or refusal to sign informed consent; (16)Allergic to tripterygium glycosides or their auxiliary ingredients; (17)Conditions that other researchers considered inappropriate for inclusion in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate to knee pain relief; | — |
Secondary
| Measure | Time frame |
|---|---|
| FACIT-T score;WOMAC score;Knee pain and function scores;Overall patient evaluation;Serum inflammatory factor;OMERACT ultrasound knee score;SMI score;salvage drug use rate;Lequesne index;SF-12 score;OMERACT-OARSI response rate;Incidence of adverse events; | — |
Countries
China
Contacts
Public ContactZhe Chen
Zhe Chen
Outcome results
None listed