The Efficacy and Safety of Curcuma Domestica Extracts and Ibuprofen in Knee Osteoarthritis - Full Text View

Sponsor:	Mahidol University
Collaborator:	National Research Council of Thailand
Information provided by:	Mahidol University
ClinicalTrials.gov Identifier:	NCT00792818

Purpose

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	Intervention	Phase
Osteoarthritis	Drug: Curcuma domestica extracts Drug: Ibuprofen	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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

Resource links provided by NLM:

MedlinePlus related topics: Osteoarthritis

Drug Information available for: Ibuprofen Curcumin Turmeric extract

U.S. FDA Resources

Further study details as provided by Mahidol University:

Primary Outcome Measures:

Change in mean WOMAC pain subscale [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Adverse events [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Quality of life: SF-36 [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Change in WOMAC score [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	396
Study Start Date:	December 2008
Estimated Study Completion Date:	July 2011
Estimated Primary Completion Date:	June 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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.

Eligibility

Ages Eligible for Study:	50 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00792818

Contacts

Contact: Vilai - Kuptniratsaikul, MD.

662-419-7511 ext -

sivkp@mahidol.ac.th

Locations

Thailand
Faculty of Medicine Siriraj Hospital, Mahidol University	Recruiting
Bangkok, Thailand, 10700
Contact: Vilai Kuptniratsaikul, MD. 662-419-7511 ext - sivkp@mahidol.ac.th
Sub-Investigator: Piyapat Dejpratham, MD.
Faculty of Medicine, Chiang Mai University	Recruiting
Chiang Mai, Thailand, 50200
Contact: Montana - Pukhuk, MD 661-472-4276 ext - montana_md@hotmail.com
KhonKaen University Hospital	Recruiting
KhonKaen, Thailand
Contact: Pattra Wattanapan, MD 664-611-3045 ext - po_wattana@yahoo.co.th
VachiraPhuket Hospital	Recruiting
Phuket, Thailand, 83000
Contact: Supphalak Laongpech, MD 667-636-1234 ext - supphalaja@yahoo.com
Rajburi Hospital	Recruiting
Rajburi, Thailand
Contact: Pranee Lukkanapichonchut, MD 663-232-7999 ext - praneeluk@yahoo.com
Songkla Hospital	Recruiting
Songkla, Thailand
Contact: Chirawan Chootip, MD 661-540-9313 ext - cchootip@yahoo.com
Contact: , MD

Sponsors and Collaborators

Mahidol University

National Research Council of Thailand

Investigators

Principal Investigator:

Vilai - Kuptniratsaikul, MD.

Mahidol University

More Information

No publications provided

Responsible Party:	Associate Professor Vilai Kuptniratsaikul, Rehabilitation Medicine, Faculty of Medicine Siriraj Hospital
ClinicalTrials.gov Identifier:	NCT00792818 History of Changes
Other Study ID Numbers:	Si134/2008
Study First Received:	November 16, 2008
Last Updated:	May 6, 2011
Health Authority:	Thailand: Ethical Committee

Keywords provided by Mahidol University:

Osteoarthritis, Knee, Curcumin, Multicenter, RCT

Additional relevant MeSH terms:

Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Curcumin
Ibuprofen
Turmeric extract
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents

Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents
Cyclooxygenase Inhibitors
Antioxidants
Protective Agents

ClinicalTrials.gov processed this record on February 09, 2012