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

Osteoarthritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00792818
• Other study ID #: Si134/2008
• Status: Completed
• Phase: Phase 3
• First received: November 16, 2008
• Last updated: October 27, 2012
• Start date: December 2008
• Est. completion date: October 2012

Study information

• Verified date: October 2012
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 367
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Drug:
• Curcuma domestica extracts
1,500 mg per day (oral)divided into 3 times for 28 days
• Ibuprofen
1,200 mg/days (oral) divided into 3 times for 28 days

Locations

Country	Name	City	State
Thailand	Faculty of Medicine Siriraj Hospital, Mahidol University	Bangkok
Thailand	Faculty of Medicine, Chiang Mai University	Chiang Mai
Thailand	KhonKaen University Hospital	KhonKaen
Thailand	VachiraPhuket Hospital	Phuket
Thailand	Rajburi Hospital	Rajburi
Thailand	Songkla Hospital	Songkla

Sponsors (2)

Lead Sponsor	Collaborator
Mahidol University	National Research Council of Thailand

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in mean WOMAC pain subscale		12 months	No
Secondary	Adverse events		12 months	Yes
Secondary	Quality of life: SF-36		12 months	No
Secondary	Change in WOMAC score		12 months	No