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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00792818

Enrollment

367

Registered

2008-11-18

Start date

2008-12-31

Completion date

2012-10-31

Last updated

2012-10-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis

Keywords

Osteoarthritis, Knee, Curcumin, Multicenter, RCT

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.

Interventions

DRUGCurcuma domestica extracts

1,500 mg per day (oral)divided into 3 times for 28 days

DRUGIbuprofen

1,200 mg/days (oral) divided into 3 times for 28 days

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

50 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Change in mean WOMAC pain subscale	12 months

Secondary

Measure	Time frame
Adverse events	12 months
Quality of life: SF-36	12 months
Change in WOMAC score	12 months

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026