Health Condition 1: M170- Bilateral primary osteoarthritis of knee
Conditions
Interventions
Intervention1: Duloxetine: 30mg orally , 1 tablet once daily for 6 months
Control Intervention1: Pregabalin: 75mg orally , 1 tablet once daily for 6 months
Control Intervention2: Placebo: orally , 1 t
Sponsors
Department of Rheumatology
Eligibility
Inclusion criteria
Inclusion criteria: Patients with American College of Rheumatology clinical and radiographic criteria of primary knee OA with evidence of inflammation (pain and swelling with decreased function). Disease activity: WOMAC score more than 10 with radiological score of KL 2 & 3.
Exclusion criteria
Exclusion criteria: Secondary arthritis. Any Comorbidities except controlled DM , HTN , Hypothyroid , dyslipidemias History of taking antiepileptic medication Nonambulatory Patients who have psychiatric disorders, including major depressive disorder known hypersensitivity to Duloxetine / pregabalin or any of the inactive ingredients, or frequent or severe allergic reactions to multiple medications. Pregnant or breast feeding females Women of child-bearing potential not using highly effective contraception. Evidence or history of malignancy, with the exception of adequately treated or excised non-metastatic basal or squamous cell cancer of the skin or cervical carcinoma in situ.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of patients with Improvement of 20 % in WOMAC and ICOAP with treatment Timepoint: at baseline , 3 months and 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Correlation of icoap in Indian patients in comparison to womac Timepoint: 6 months | — |
Countries
India
Contacts
Public ContactHarsh Jain
Department of Clinical Immunology and Rheumatology , SSKM Hospital
Outcome results
None listed