Knee Osteoarthritis
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: (1) Meet the diagnostic criteria for Western medicine (knee osteoarthritis); (2) Meet the TCM syndrome differentiation criteria (Liver-Kidney Deficiency Pattern); (3) Age between 50 and 75 years (inclusive); (4) Meet the radiographic Kellgren-Lawrence classification criteria (Grade I, II, or III); (5) Visual Analog Scale (VAS) pain score between 1 and 6 (inclusive); (6) Voluntarily sign the informed consent form and agree to participate in examinations and treatment as required by the trial protocol.
Exclusion criteria
Exclusion criteria: (1) Patients who have taken any Chinese or Western medications proven effective in alleviating symptoms of knee osteoarthritis within one month prior to treatment; (2) Patients who have undergone surgical interventions (including arthroscopic surgery, etc.); (3) Patients with known allergies to any drug or ingredient used in this study; (4) Patients with severe or unstable cardiovascular or cerebrovascular diseases, acute or poorly controlled systemic illnesses (e.g., severe primary diseases of the liver, kidney, hematopoietic system, or endocrine system), or diabetes with inadequate glycemic control after treatment (fasting blood glucose > 11.1 mmol/L); (5) Pregnant women, women planning pregnancy, or breastfeeding mothers; (6) Patients with psychiatric disorders, lack of self-awareness, inability to accurately express symptoms or adhere to medication schedules, or those deemed unable to provide reliable outcome evaluations for this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effective Rate Based on TCM Syndrome Score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Visual Analogue Scale (VAS) Score;Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Score;Hospital for Special Surgery (HSS) Knee Score;Erythrocyte Sedimentation Rate (ESR);C-Reactive Protein (CRP);Tumor Necrosis Factor-alpha (TNF-a);Interleukin-1 beta (IL-1ß);Interleukin-6; | — |
Countries
China
Contacts
Shanghai Guanghua Hospital of Integrated Medicine