Arthritis
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. The subject must fully understand the purpose, procedures, and related requirements of this study, voluntarily sign an informed consent form, and indicate their willingness to participate in the study; 2. The subject's age should be between 18 and 65 years, with no gender restrictions; 3. The subject's diagnosis must strictly meet the Western medical diagnostic criteria for knee osteoarthritis as outlined in the "Guidelines for the Diagnosis and Treatment of Osteoarthritis (2018 Edition)."; 4. At screening, the baseline pain score of the study-side knee on a 100-mm visual analog scale (VAS) (during activity: walking) should be between 40 mm and 80 mm, excluding 80 mm (>=40 mm and <80 mm); 5. From the screening period through the entire trial treatment period, the subject should avoid any non-habitual physical activity.
Exclusion criteria
Exclusion criteria: 1. The subject has had an open knee injury or undergone other knee surgeries (e.g., arthroscopy, arthroscopic debridement, knee replacement) within one year prior to screening; 2. The subject has received intra-articular drug injections (e.g., corticosteroids, hyaluronic acid, chitosan, growth factors, platelet-rich plasma) within three months prior to screening; 3. Subjects must not have used any medications for osteoarthritis (including analgesics, NSAIDs, slow-acting drugs for OA symptom relief, anti-neuropathic pain drugs, or Chinese patent medicines) within one week prior to randomization, except for rescue medications or low-dose aspirin (<=325 mg/day) for cardiovascular disease prevention; 4. Subjects must not have used anti-anxiety medications (e.g., duloxetine, doxepin, amitriptyline) within one month prior to randomization; 5. Subjects clinically diagnosed with gout or hyperuricemia; 6. Pregnant or lactating women, or those with plans to conceive within three months; 7. The investigator deems the subject unsuitable for other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 100 mm visual analog scale (VAS);Quantitative Grading Standards for Syndromes;Health Assessment Questionnaire Index;WOMAC score for knee osteoarthritis; | — |
Countries
China
Contacts
Hefei Boe Hospital