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

Condition(s) targeted: Osteoarthritis

Intervention: Curcuma domestica extracts (Drug); Ibuprofen (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Mahidol University

Official(s) and/or principal investigator(s):
Vilai - Kuptniratsaikul, MD., Principal Investigator, Affiliation: Mahidol University

Overall contact:
Vilai - Kuptniratsaikul, MD., Phone: 662-419-7511, Ext: -, Email: sivkp@mahidol.ac.th

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.

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 design: Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Change in mean WOMAC pain subscale

Secondary outcome:

Adverse events

Quality of life: SF-36

Change in WOMAC score

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.

Minimum age: 50 Years. Maximum age: 75 Years. Gender(s): Both.

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

Vilai - Kuptniratsaikul, MD., Phone: 662-419-7511, Ext: -, Email: sivkp@mahidol.ac.th

Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok 10700, Thailand; Recruiting
Vilai Kuptniratsaikul, MD., Phone: 662-419-7511, Ext: -, Email: sivkp@mahidol.ac.th
Piyapat Dejpratham, MD., Sub-Investigator

Faculty of Medicine, Chiang Mai University, Chiang Mai 50200, Thailand; Recruiting
Montana - Pukhuk, MD, Phone: 661-472-4276, Ext: -, Email: montana_md@hotmail.com

VachiraPhuket Hospital, Phuket 83000, Thailand; Recruiting
Supphalak Laongpech, MD, Phone: 667-636-1234, Ext: -, Email: supphalaja@yahoo.com

Rajburi Hospital, Rajburi, Thailand; Recruiting
Pranee Lukkanapichonchut, MD, Phone: 663-232-7999, Ext: -, Email: praneeluk@yahoo.com

Songkla Hospital, Songkla, Thailand; Recruiting
Chirawan Chootip, MD, Phone: 661-540-9313, Ext: -, Email: cchootip@yahoo.com
MD

KhonKaen University Hospital, KhonKaen, Thailand; Recruiting
Pattra Wattanapan, MD, Phone: 664-611-3045, Ext: -, Email: po_wattana@yahoo.co.th

Starting date: December 2008
Ending date: July 2010
Last updated: September 17, 2009