Moderate to severe osteoarthritis of the knee. Osteoarthritis of knee, unspecified
Conditions
Interventions
Intervention 1: Intervention group: The intervention group will receive 10 mg of Apermilast from the first to the twelfth day, 20 mg of Apermilast from the thirteenth to the twenty-fifth day, and 30 m
Sponsors
Abidi Pharmaceutical Company
Eligibility
Sex/Gender
All
Age
40 Years to 75 Years
Inclusion criteria
Inclusion criteria: Patients aged 40 to 75 years Clinical and radiological diagnosis of knee osteoarthritis (OA) based on ACR criteria WOMAC pain score =4 Kellgren -Lawrence grade II, III in radiography No use of other joint disease-modifying medications in the last 3 months
Exclusion criteria
Exclusion criteria: Severe osteoarthritis (Kellgren and Lawrence system grade IV) History of inflammatory joint diseases (RA, PsA, gout) Concomitant use of systemic corticosteroids or intra-articular injections in the last 4 weeks Severe heart disease, kidney failure (CrCl < 30), or liver failure Psychiatric disorders or severe depression History of sensitivity or intolerance to PDE4 inhibitors
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Serum levels of the inflammatory factor IL-6. Timepoint: Week 0, Week 12. Method of measurement: Analysis of serum IL-6 levels from collected venous blood samples. | — |
Primary
| Measure | Time frame |
|---|---|
| WOMAC pain score criterion in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) questionnaire and WOMAC score. Timepoint: Week 0, Week 4, Week 8, Week 12. Method of measurement: Assessment of pain and physical function using the WOMAC questionnaire. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactFatemeh Saghafi
Yazd University of Medical Sciences
Outcome results
None listed