The Efficacy and Safety of Curcuma Domestica Extracts and Ibuprofen in Knee Osteoarthritis

• Status: Completed
• Trial end date: 2012-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mahidol University
• Collaborator: National Research Council of Thailand
• Treatments: Curcumin; Ibuprofen; Turmeric extract

Criteria

Inclusion Criteria:

• Primary osteoarthritis

• Knee pain score more than or equal to 5 point (NRS 0-10)

• Age >= 50 years, not > 75 years

• Knee crepitus

• Knee stiffness less than 30 minutes

• Urine pregnancy test negative in case of not being menopausal period

Exclusion Criteria:

• History of GI ulcer or melena

• Having hepatic or bile duct diseases(SGOT ≥ 37 u/L, SGPT ≥ 40 u/L)

• Having renal disease or abnormal renal functions (serum creatinine ≥ 1.5 mg/dl)

• Asthma or gout

• Allergy to ibuprofen or curcumin

• History of intraarticular knee injection within 6 months

• Post knee arthroplasty

• History of intermittent claudication

• Unable to walk, for example hemiplegia, severe lung/heart diseases

• Knee x-ray found chondrocalcinosis

• On anticoagulant