knee osteoarthritis
Conditions
Interventions
Celecoxib group (control group):Oral administration of Celecoxib Capsules, Celecoxib Capsules (Shijiazhuang Pharmaceutical Group Eu Pharmaceutical Co., Ltd., specification: 0.2g, National Medical Prod
Xibining Group II (Observation Group):Oral administration of Knee Bi Ning II decoction:Knee Bi Ning II is uniformly decocted by the hospital. Composition and dosage of Knee Bi Ning II: 10g of processe
Sponsors
Nanjing First Hospital
Eligibility
Sex/Gender
All
Age
40 Years to 80 Years
Inclusion criteria
Inclusion criteria: (1) Referring to the "Chinese Guidelines for the Diagnosis and Treatment of Osteoarthritis" (2021 edition), subjects who meet the diagnostic criteria for knee osteoarthritis; (2) Subjects who meet the X-ray grading criteria of stages 1-3; (3) Subjects who meet the criteria for Bi syndrome - pain syndrome in Traditional Chinese Medicine (TCM), and are diagnosed with cold-dampness obstruction syndrome according to TCM differentiation; (4) Subjects aged 40-80 years, with no restriction on gender; (5) Subjects willing to participate in the trial and sign the informed consent form.
Exclusion criteria
Exclusion criteria: (1) Within 2 weeks, subjects who have taken or used other anti-inflammatory and analgesic drugs, hormonal drugs, etc., which may affect the study results; (2) Subjects with severe impairment of heart, liver, or kidney function; (3) Pregnant or breastfeeding women, individuals with mental disorders, or other vulnerable populations; (4) Subjects with a history of allergy to the study drug; (5) Subjects with secondary knee joint injuries caused by other diseases such as connective tissue diseases, metabolic bone diseases, tuberculosis, or tumors; (6) Subjects with poor compliance.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC); | — |
Secondary
| Measure | Time frame |
|---|---|
| Serum inflammatory factor detection;Cartilage catabolism-related indicators;range of motion,ROM;hospital anxiety and depression score,HADS;Short Form 36 Health Survey,SF-36;VAS;Wind-Cold-Damp Arthralgia Syndrome and Osteoarthritis Scoring;5 sit-up tests;Timed Up and Go Test;Adverse Event;Liver and Kidney Function Tests; | — |
Countries
China
Contacts
Public ContactChen An Liang
Nanjing First Hospital
Outcome results
None listed