Clinical trial NCT00792818: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Osteoarthritis
Keywords: Osteoarthritis, Knee, Curcumin, Multicenter, RCT
Lead sponsor: Mahidol University
Sponsor class: OTHER
Collaborators: name: National Research Council of Thailand
First posted: 2008-11-18
Enrollment: 367
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in mean WOMAC pain subscale
timeFrame: 12 months
Secondary outcomes:
measure: Adverse events
timeFrame: 12 months
measure: Quality of life: SF-36
timeFrame: 12 months
measure: Change in WOMAC score
timeFrame: 12 months
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Faculty of Medicine Siriraj Hospital, Mahidol University
city: Chiang Mai
country: Thailand
facility: Faculty of Medicine, Chiang Mai University
city: KhonKaen
country: Thailand
facility: KhonKaen University Hospital
city: Phuket
country: Thailand
facility: VachiraPhuket Hospital
city: Rajburi
country: Thailand
facility: Rajburi Hospital
city: Songkla
country: Thailand
facility: Songkla Hospital
Study officials:
affiliation: Mahidol University
name: Vilai - Kuptniratsaikul, MD.
role: PRINCIPAL_INVESTIGATOR
References:
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.