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

Mahidol University

Status and phase: Completed; Phase 3

Conditions: Osteoarthritis

Treatments: Drug: Curcuma domestica extracts; Drug: Ibuprofen

Study type: Interventional

Funder types: Other

Identifiers

NCT00792818

Si134/2008

Details and patient eligibility

About

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.

Full 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.

Enrollment: 367 patients

Sex: All

Ages: 50 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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367 participants in 2 patient groups

curcuma domestica

Experimental group

Description:

1,500 mg/day (oral) divided into 3 times for 28 days

Treatment:

Drug: Curcuma domestica extracts

Ibuprofen

Active Comparator group

Description:

1,200 mg/day (oral) divided into 3 times for 28 days

Treatment:

Drug: Ibuprofen