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

Phase 3

Completed

• Conditions: Osteoarthritis
• Interventions: Drug: Curcuma domestica extracts; Drug: Ibuprofen

• Registration Number: NCT00792818
• Lead Sponsor: Mahidol University

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 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.

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 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.

Study Timeline

• Study First Submitted: 2008-11-16
• Study First Submitted QC: 2008-11-16
• Study First Posted: 2008-11-18
• Study Start: 2008-12
• Status Verified: 2012-10
• Primary Completion: 2012-10
• Study Completion: 2012-10
• Last Update Submitted: 2012-10-27
• Last Update Posted: 2012-10-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 367

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
curcuma domestica	Curcuma domestica extracts	1,500 mg/day (oral) divided into 3 times for 28 days
Ibuprofen	Ibuprofen	1,200 mg/day (oral) divided into 3 times for 28 days

Primary Outcome Measures

Name	Time	Method
Change in mean WOMAC pain subscale	12 months

Secondary Outcome Measures

Name	Time	Method
Adverse events	12 months
Quality of life: SF-36	12 months
Change in WOMAC score	12 months

Trial Locations

Locations (6)

Faculty of Medicine Siriraj Hospital, Mahidol University; 🇹🇭 Bangkok, Thailand

VachiraPhuket Hospital; 🇹🇭 Phuket, Thailand

Faculty of Medicine, Chiang Mai University; 🇹🇭 Chiang Mai, Thailand

KhonKaen University Hospital; 🇹🇭 KhonKaen, Thailand

Rajburi Hospital; 🇹🇭 Rajburi, Thailand

Songkla Hospital; 🇹🇭 Songkla, Thailand