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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00792818
Recruitment Status : Completed
First Posted : November 18, 2008
Last Update Posted : October 30, 2012
National Research Council of Thailand
Information provided by (Responsible Party):
Vilai Kuptniratsaikul, 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.

Condition or disease Intervention/treatment Phase
Osteoarthritis Drug: Curcuma domestica extracts Drug: Ibuprofen Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 367 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : December 2008
Actual Primary Completion Date : October 2012
Actual Study Completion Date : October 2012

Arm Intervention/treatment
Experimental: curcuma domestica
1,500 mg/day (oral) divided into 3 times for 28 days
Drug: Curcuma domestica extracts
1,500 mg per day (oral)divided into 3 times for 28 days
Other Name: Curcumin

Active Comparator: Ibuprofen
1,200 mg/day (oral) divided into 3 times for 28 days
Drug: Ibuprofen
1,200 mg/days (oral) divided into 3 times for 28 days
Other Name: Brufen

Primary Outcome Measures :
  1. Change in mean WOMAC pain subscale [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Adverse events [ Time Frame: 12 months ]
  2. Quality of life: SF-36 [ Time Frame: 12 months ]
  3. Change in WOMAC score [ Time Frame: 12 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00792818

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Faculty of Medicine Siriraj Hospital, Mahidol University
Bangkok, Thailand, 10700
Faculty of Medicine, Chiang Mai University
Chiang Mai, Thailand, 50200
KhonKaen University Hospital
KhonKaen, Thailand
VachiraPhuket Hospital
Phuket, Thailand, 83000
Rajburi Hospital
Rajburi, Thailand
Songkla Hospital
Songkla, Thailand
Sponsors and Collaborators
Mahidol University
National Research Council of Thailand
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Principal Investigator: Vilai - Kuptniratsaikul, MD. Mahidol University
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Vilai Kuptniratsaikul, Associate Professor, Mahidol University Identifier: NCT00792818    
Other Study ID Numbers: Si134/2008
First Posted: November 18, 2008    Key Record Dates
Last Update Posted: October 30, 2012
Last Verified: October 2012
Keywords provided by Vilai Kuptniratsaikul, Mahidol University:
Osteoarthritis, Knee, Curcumin, Multicenter, RCT
Additional relevant MeSH terms:
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Osteoarthritis, Knee
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Turmeric extract
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Protective Agents