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Completed

NCT Number: NCT00792818

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

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.

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Key information

Conditions

Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases

Age range

50 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Curcuma domestica extracts

Drug

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

Other names: Curcumin

Ibuprofen

Drug

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

Other names: Brufen

Primary outcomes

  1. Change in mean WOMAC pain subscale

    Time frame: 12 months

Secondary outcomes

  1. Adverse events

    Time frame: 12 months

  2. Quality of life: SF-36

    Time frame: 12 months

  3. Change in WOMAC score

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Collaborators

  • National Research Council of Thailand

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Nov 18, 2008
Registry last updated
Oct 30, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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