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

Study Overview
=================
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.

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

Conditions
-----------------
Osteoarthritis

Intervention / Treatment
-----------------
* Drug: Curcuma domestica extracts
* Drug: Ibuprofen


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: curcuma domestica<br>1,500 mg/day (oral) divided into 3 times for 28 days | Drug: Curcuma domestica extracts<br>* 1,500 mg per day (oral)divided into 3 times for 28 days<br>* Other names: Curcumin;|
| Active Comparator: Ibuprofen<br>1,200 mg/day (oral) divided into 3 times for 28 days | Drug: Ibuprofen<br>* 1,200 mg/days (oral) divided into 3 times for 28 days<br>* Other names: Brufen;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in mean WOMAC pain subscale |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events |  | 12 months | 
| Quality of life: SF-36 |  | 12 months | 
| Change in WOMAC score |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Osteoarthritis, Knee, Curcumin, Multicenter, RCT