Osteoarthritis Clinical Trial
Official title:
Phase 4 Study of Diacerein as Adjuvant to Diclofenac Sodium in Indian Patients of OA Knee
The purpose of this study is to evaluate clinical effectiveness of diacerein as add on therapy to diclofenac sodium in Indian patients of osteoarthritis (OA) knee.
Currently symptomatic relief is provided by the use of nonsteroidal anti-inflammatory drugs
(NSAIDs) but they do not reverse the basic pathology of disease, rather may accelerate it,
like degeneration of cartilage, inhibition of chondroitin synthesis and suppression of
proteoglycans synthesis by the chondrocyte.
Research shows that IL-1β plays a fundamental role in osteoarthritis pathophysiology and
cartilage destruction. Diacerein, a purified compound with anthraquinonic structure,
inhibits IL-1β, retarding all pathological processes initiated in OA. Also, Diacerein has
proven analgesic efficacy comparable to that of diclofenac in patients of osteoarthritis
knee12. Because of these factors, the present study has been planned to evaluate the
clinical effectiveness of diacerein as add on therapy to diclofenac sodium in Indian
patients of symptomatic OA knee.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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