Osteoarthritis Clinical Trial
Official title:
The Efficacy and Safety of Curcuma Domestica Extracts and Ibuprofen for Therapy of Patients With Knee Osteoarthritis, the Randomized Double-blinded Controlled Trial, Multicenter Study
Osteoarthritis of knee is common degenerative musculoskeletal diseases. Non-steroidal antiinflammatory drugs (NSAIDs) are used to decrease pain symptom but someone can not tolerate its gastrointestinal adverse effects. In vitro studies showed that curcumin had an inhibitory effect on substances playing an important role in inflammatory pathway. The mechanisms by which curcumin prevents inflammation are postulated through inhibition of many cytokines, for example, lipo-oxygenase, cyclo-oxygenase, and phospholipase. Therefore, if curcumin is effective as NSAIDs with less side effects, it can be an alternative treatment for those OA knee patients.
Curcumin was demonstrated to be safe and had anti-inflammatory activity in six studies in
humans. It may exert its anti-inflammatory activity by inhibition of a number of different
molecules that play a role in inflammation.
Our experience in a study of 100 subjects revealed a trend towards a greater effect in OA
patients receiving Curcuma domestica extracts. However, studies with adequate sample and
dosage of Ibuprofen are recommended to demonstrate the efficacy of C.domestica extracts in
alleviating knee pain and improving knee functions.
The objective of the study was to determine the efficacy and safety of C.domestica extracts
in pain reduction and functional improvement in patients with knee osteoarthritis.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
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