OsteoarthritisPhase 3NCT00792818
The Efficacy and Safety of Curcuma Domestica Extracts and Ibuprofen in Knee Osteoarthritis
A Phase 3 study testing Curcuma domestica extracts and Ibuprofen in people with Osteoarthritis, run by Mahidol University at 6 sites in Thailand.
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. Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Curcuma domestica extracts and Ibuprofen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 367 participants
- Where
- 6 sitesThailand
- Study dates
- Dec 2008to Oct 2012
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- Post knee arthroplasty
- History of intermittent claudication
- Unable to walk, for example hemiplegia, severe lung/heart diseases
- Knee x-ray found chondrocalcinosis
- On anticoagulant
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Thailand6 sites
Faculty of Medicine Siriraj Hospital, Mahidol University
Bangkok, 10700
Faculty of Medicine, Chiang Mai University
Chiang Mai, 50200
KhonKaen University Hospital
KhonKaen
VachiraPhuket Hospital
Phuket, 83000
Rajburi Hospital
Ratchaburi
Songkla Hospital
Songkhla
About this study
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
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.
Read the 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.
- Conditions
- Osteoarthritis
- Being tested
- Curcuma domestica extracts, Ibuprofen
- Keywords
- Osteoarthritis, Knee, Curcumin, Multicenter, RCT
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Curcuma domestica extractsDrug
Also called Curcumin
1,500 mg per day (oral)divided into 3 times for 28 days
IbuprofenDrug
Also called Brufen
1,200 mg/days (oral) divided into 3 times for 28 days
| Study group | Role | What they receive |
|---|---|---|
| curcuma domestica | Experimental | 1,500 mg/day (oral) divided into 3 times for 28 days Receives: Drug: Curcuma domestica extracts |
| Ibuprofen | Active comparator | 1,200 mg/day (oral) divided into 3 times for 28 days Receives: Drug: Ibuprofen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in mean WOMAC pain subscale
Measured: 12 months
Secondary outcomes (3)
Adverse events
Measured: 12 months
Quality of life: SF-36
Measured: 12 months
Change in WOMAC score
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2008 (estimated)
- Study startDec 2008
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 367 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Collaborators
- National Research Council of Thailand
- Responsible party
- Principal investigator, Vilai Kuptniratsaikul, Mahidol University
- Investigators
- Vilai - Kuptniratsaikul, MD., Principal investigator, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00792818
- Sponsor's protocol ID
- Si134/2008
- Status last verified
- Oct 2012
- First submitted
- 16 Nov 2008
- Last updated
- 30 Oct 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kuptniratsaikul V, Dajpratham P, Taechaarpornkul W, Buntragulpoontawee M, Lukkanapichonchut P, Chootip C, Saengsuwan J, Tantayakom K, Laongpech S. Efficacy and safety of Curcuma domestica extracts compared with ibuprofen in patients with knee osteoarthritis: a multicenter study. Clin Interv Aging. 2014 Mar 20;9:451-8. doi: 10.2147/CIA.S58535. eCollection 2014.
PubMed 24672232
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00792818
- Acronym / sponsor ID
- Si134/2008
- Conditions
- Osteoarthritis
- Keywords
- Osteoarthritis, Knee, Curcumin, Multicenter, RCT
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 367 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Collaborators
- National Research Council of Thailand
- Study start
- Dec 2008
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 18 Nov 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| curcuma domestica | Experimental | Drug: Curcuma domestica extracts1,500 mg/day (oral) divided into 3 times for 28 days |
| Ibuprofen | Active comparator | Drug: Ibuprofen1,200 mg/day (oral) divided into 3 times for 28 days |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Curcuma domestica extractsAlso: Curcumin1,500 mg per day (oral)divided into 3 times for 28 days | Drug | curcuma domestica |
| IbuprofenAlso: Brufen1,200 mg/days (oral) divided into 3 times for 28 days | Drug | Ibuprofen |
Primary outcome
Change in mean WOMAC pain subscale
Time frame: 12 months
3 secondary outcomes
Adverse events
Time frame: 12 months
Quality of life: SF-36
Time frame: 12 months
Change in WOMAC score
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2012.
- Derived from this study: PubMed 24672232Kuptniratsaikul V, Dajpratham P, Taechaarpornkul W, Buntragulpoontawee M, Lukkanapichonchut P, Chootip C, Saengsuwan J, Tantayakom K, Laongpech S. Efficacy and safety of Curcuma domestica extracts compared with ibuprofen in patients with knee osteoarthritis: a multicenter study. Clin Interv Aging. 2014 Mar 20;9:451-8. doi: 10.2147/CIA.S58535. eCollection 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vilai - Kuptniratsaikul, MD. principal investigator
Mahidol University
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Curcuma domestica extracts and Ibuprofen in people with Osteoarthritis, run by Mahidol University at 6 sites in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in mean WOMAC pain subscale (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00792818, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2012.