knee osteoarthritis
Conditions
Interventions
Group1:Meloxicam tablets and Iguratimod
Group2:Meloxicam tablets and placebo
Sponsors
Beijing Jishuitan Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Age >= 18 years, regardless of gender; 2.meets the diagnostic criteria for knee osteoarthritis as outlined in the Chinese Guidelines for Diagnosis and Treatment of Osteoarthritis (2024 Edition); 3.at screening, the average visual analog scale (VAS) score for pain in the target knee joint according to the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) subscale A was >=40 mm and <=80 mm; 4.the target knee joint was classified as Kellgren-Lawrence grade I-III, and the other knee joint was of a grade not exceeding that of the target knee; 5.voluntarily participated and provided written informed consent.
Exclusion criteria
Exclusion criteria: 1.Individuals with allergies to Iguratimod tablets, placebo, Meloxicam tablets, other non-steroidal anti-inflammatory drugs (NSAIDs), or aspirin; 2.individuals with active or newly developed gastrointestinal ulcers, perforation, or other hemorrhagic diseases; 3.individuals scheduled to undergo lower limb surgery during the study period; 4.individuals with severe hepatic or renal dysfunction, leukopenia, anemia, or thrombocytopenia; 5.female participants with a positive pregnancy test or who are lactating, or participants of childbearing potential who are unable to use effective contraception during the trial and for 6 months after the last dose, or who plan to become pregnant; 6.individuals with any other conditions deemed by the investigator as unsuitable for participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in the WOMAC pain subscale score (Subscale A) for the knee joint; | — |
Secondary
| Measure | Time frame |
|---|---|
| Total Score of the Knee Joint WOMAC Scale;Knee Joint WOMAC Scale A (Pain) Score;Knee Joint WOMAC Scale B (Stiffness) Score;Knee Joint WOMAC Scale C (Physical Function) Score;Percentage of participants with positive knee joint response;MRI images and ultrasound measurement results;SF-36 Scale Score; | — |
Countries
China
Contacts
Public ContactDeng Xiaoli
Beijing Jishuitan Hospital, Capital Medical University
Outcome results
None listed