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

This study has been completed.
Sponsor:
Collaborator:
National Research Council of Thailand
Information provided by (Responsible Party):
Vilai Kuptniratsaikul, Mahidol University
ClinicalTrials.gov Identifier:
NCT00792818
First received: November 16, 2008
Last updated: October 27, 2012
Last verified: October 2012
  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 3

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:


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 ]

Enrollment: 367
Study Start Date: December 2008
Study Completion Date: October 2012
Primary Completion Date: October 2012 (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

Locations
Thailand
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
Investigators
Principal Investigator: Vilai - Kuptniratsaikul, MD. Mahidol University
  More Information

No publications provided

Responsible Party: Vilai Kuptniratsaikul, Associate Professor, Mahidol University
ClinicalTrials.gov Identifier: NCT00792818     History of Changes
Other Study ID Numbers: Si134/2008
Study First Received: November 16, 2008
Last Updated: October 27, 2012
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 April 21, 2014