Status:
COMPLETED
The Efficacy and Safety of Curcuma Domestica Extracts and Ibuprofen in Knee Osteoarthritis
Lead Sponsor:
Mahidol University
Collaborating Sponsors:
National Research Council of Thailand
Conditions:
Osteoarthritis
Eligibility:
All Genders
50-75 years
Phase:
PHASE3
Brief 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 gastrointestina...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
367 Patients enrolled
Trial Details
Trial ID
NCT00792818
Start Date
December 1 2008
End Date
October 1 2012
Last Update
October 30 2012
Active Locations (6)
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1
Faculty of Medicine Siriraj Hospital, Mahidol University
Bangkok, Thailand, 10700
2
Faculty of Medicine, Chiang Mai University
Chiang Mai, Thailand, 50200
3
KhonKaen University Hospital
KhonKaen, Thailand
4
VachiraPhuket Hospital
Phuket, Thailand, 83000