The Efficacy and Safety of Curcuma Domestica Extracts and Ibuprofen in Knee Osteoarthritis
Primary Purpose
Osteoarthritis
Status
Completed
Phase
Phase 3
Locations
Thailand
Study Type
Interventional
Intervention
Curcuma domestica extracts
Ibuprofen
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis focused on measuring Osteoarthritis, Knee, Curcumin, Multicenter, RCT
Eligibility 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
Sites / Locations
- Faculty of Medicine Siriraj Hospital, Mahidol University
- Faculty of Medicine, Chiang Mai University
- KhonKaen University Hospital
- VachiraPhuket Hospital
- Rajburi Hospital
- Songkla Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
curcuma domestica
Ibuprofen
Arm Description
1,500 mg/day (oral) divided into 3 times for 28 days
1,200 mg/day (oral) divided into 3 times for 28 days
Outcomes
Primary Outcome Measures
Change in mean WOMAC pain subscale
Secondary Outcome Measures
Adverse events
Quality of life: SF-36
Change in WOMAC score
Full Information
NCT ID
NCT00792818
First Posted
November 16, 2008
Last Updated
October 27, 2012
Sponsor
Mahidol University
Collaborators
National Research Council of Thailand
1. Study Identification
Unique Protocol Identification Number
NCT00792818
Brief Title
The Efficacy and Safety of Curcuma Domestica Extracts and Ibuprofen in Knee Osteoarthritis
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 Type
Interventional
2. Study Status
Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
October 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mahidol University
Collaborators
National Research Council of Thailand
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis
Keywords
Osteoarthritis, Knee, Curcumin, Multicenter, RCT
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
367 (Actual)
8. Arms, Groups, and Interventions
Arm Title
curcuma domestica
Arm Type
Experimental
Arm Description
1,500 mg/day (oral) divided into 3 times for 28 days
Arm Title
Ibuprofen
Arm Type
Active Comparator
Arm Description
1,200 mg/day (oral) divided into 3 times for 28 days
Intervention Type
Drug
Intervention Name(s)
Curcuma domestica extracts
Other Intervention Name(s)
Curcumin
Intervention Description
1,500 mg per day (oral)divided into 3 times for 28 days
Intervention Type
Drug
Intervention Name(s)
Ibuprofen
Other Intervention Name(s)
Brufen
Intervention Description
1,200 mg/days (oral) divided into 3 times for 28 days
Primary Outcome Measure Information:
Title
Change in mean WOMAC pain subscale
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Adverse events
Time Frame
12 months
Title
Quality of life: SF-36
Time Frame
12 months
Title
Change in WOMAC score
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vilai - Kuptniratsaikul, MD.
Organizational Affiliation
Mahidol University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Medicine Siriraj Hospital, Mahidol University
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
Facility Name
Faculty of Medicine, Chiang Mai University
City
Chiang Mai
ZIP/Postal Code
50200
Country
Thailand
Facility Name
KhonKaen University Hospital
City
KhonKaen
Country
Thailand
Facility Name
VachiraPhuket Hospital
City
Phuket
ZIP/Postal Code
83000
Country
Thailand
Facility Name
Rajburi Hospital
City
Rajburi
Country
Thailand
Facility Name
Songkla Hospital
City
Songkla
Country
Thailand
12. IPD Sharing Statement
Citations:
PubMed Identifier
24672232
Citation
Kuptniratsaikul V, Dajpratham P, Taechaarpornkul W, Buntragulpoontawee M, Lukkanapichonchut P, Chootip C, Saengsuwan J, Tantayakom K, Laongpech S. Efficacy and safety of Curcuma domestica extracts compared with ibuprofen in patients with knee osteoarthritis: a multicenter study. Clin Interv Aging. 2014 Mar 20;9:451-8. doi: 10.2147/CIA.S58535. eCollection 2014.
Results Reference
derived
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The Efficacy and Safety of Curcuma Domestica Extracts and Ibuprofen in Knee Osteoarthritis
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