MedDataX Logo

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

NCT ID: NCT00792818

Last Updated: 2012-10-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

367 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Study Completion Date

2012-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Osteoarthritis

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Osteoarthritis, Knee, Curcumin, Multicenter, RCT

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

curcuma domestica

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

Group Type EXPERIMENTAL

Curcuma domestica extracts

Intervention Type DRUG

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

Ibuprofen

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

Group Type ACTIVE_COMPARATOR

Ibuprofen

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Curcuma domestica extracts

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

Intervention Type DRUG

Ibuprofen

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

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Curcumin Brufen

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

50 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Research Council of Thailand

OTHER_GOV

Sponsor Role collaborator

Mahidol University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Vilai Kuptniratsaikul

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Vilai - Kuptniratsaikul, MD.

Role: PRINCIPAL_INVESTIGATOR

Mahidol University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Faculty of Medicine Siriraj Hospital, Mahidol University

Bangkok, , Thailand

Site Status

Faculty of Medicine, Chiang Mai University

Chiang Mai, , Thailand

Site Status

KhonKaen University Hospital

KhonKaen, , Thailand

Site Status

VachiraPhuket Hospital

Phuket, , Thailand

Site Status

Rajburi Hospital

Ratchaburi, , Thailand

Site Status

Songkla Hospital

Songkhla, , Thailand

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Thailand

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 24672232 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Si134/2008

Identifier Type: -

Identifier Source: org_study_id