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

October 27, 2012 updated by: Vilai Kuptniratsaikul, Mahidol University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

367

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Bangkok, Thailand, 10700
        • Faculty of Medicine Siriraj Hospital, Mahidol University
      • Chiang Mai, Thailand, 50200
        • Faculty of Medicine, Chiang Mai University
      • KhonKaen, Thailand
        • KhonKaen University Hospital
      • Phuket, Thailand, 83000
        • VachiraPhuket Hospital
      • Rajburi, Thailand
        • Rajburi Hospital
      • Songkla, Thailand
        • Songkla Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: curcuma domestica
1,500 mg/day (oral) divided into 3 times for 28 days
Drug: Curcuma domestica extracts
1,500 mg per day (oral)divided into 3 times for 28 days
Other Names:
  • Curcumin
Active Comparator: Ibuprofen
1,200 mg/day (oral) divided into 3 times for 28 days
Drug: Ibuprofen
1,200 mg/days (oral) divided into 3 times for 28 days
Other Names:
  • Brufen

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in mean WOMAC pain subscale
Time Frame: 12 months
12 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mahidol University

Collaborators

National Research Council of Thailand

Investigators

  • Principal Investigator: Vilai - Kuptniratsaikul, MD., Mahidol University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2008

Primary Completion (Actual)

October 1, 2012

Study Completion (Actual)

October 1, 2012

Study Registration Dates

First Submitted

November 16, 2008

First Submitted That Met QC Criteria

November 16, 2008

First Posted (Estimate)

November 18, 2008

Study Record Updates

Last Update Posted (Estimate)

October 30, 2012

Last Update Submitted That Met QC Criteria

October 27, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Si134/2008

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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