Ignite Creation Date:
2025-12-25 @ 4:35 AM
Ignite Modification Date:
2025-12-26 @ 3:37 AM
Study NCT ID:
NCT00792818
Status:
COMPLETED
Last Update Posted:
2012-10-30
First Post:
2008-11-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Efficacy and Safety of Curcuma Domestica Extracts and Ibuprofen in Knee Osteoarthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010003', 'term': 'Osteoarthritis'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003474', 'term': 'Curcumin'}, {'id': 'D007052', 'term': 'Ibuprofen'}], 'ancestors': [{'id': 'D036381', 'term': 'Diarylheptanoids'}, {'id': 'D006536', 'term': 'Heptanes'}, {'id': 'D000473', 'term': 'Alkanes'}, {'id': 'D006839', 'term': 'Hydrocarbons, Acyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D002396', 'term': 'Catechols'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D010666', 'term': 'Phenylpropionates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 367}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-10', 'completionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-10-27', 'studyFirstSubmitDate': '2008-11-16', 'studyFirstSubmitQcDate': '2008-11-16', 'lastUpdatePostDateStruct': {'date': '2012-10-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-11-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in mean WOMAC pain subscale', 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': 'Adverse events', 'timeFrame': '12 months'}, {'measure': 'Quality of life: SF-36', 'timeFrame': '12 months'}, {'measure': 'Change in WOMAC score', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Osteoarthritis, Knee, Curcumin, Multicenter, RCT'], 'conditions': ['Osteoarthritis']}, 'referencesModule': {'references': [{'pmid': '24672232', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nOur 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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Primary osteoarthritis\n* Knee pain score more than or equal to 5 point (NRS 0-10)\n* Age \\>= 50 years, not \\> 75 years\n* Knee crepitus\n* Knee stiffness less than 30 minutes\n* Urine pregnancy test negative in case of not being menopausal period\n\nExclusion Criteria:\n\n* History of GI ulcer or melena\n* Having hepatic or bile duct diseases(SGOT ≥ 37 u/L, SGPT ≥ 40 u/L)\n* Having renal disease or abnormal renal functions (serum creatinine ≥ 1.5 mg/dl)\n* Asthma or gout\n* Allergy to ibuprofen or curcumin\n* History of intraarticular knee injection within 6 months\n* Post knee arthroplasty\n* History of intermittent claudication\n* Unable to walk, for example hemiplegia, severe lung/heart diseases\n* Knee x-ray found chondrocalcinosis\n* On anticoagulant'}, 'identificationModule': {'nctId': 'NCT00792818', 'briefTitle': 'The Efficacy and Safety of Curcuma Domestica Extracts and Ibuprofen in Knee Osteoarthritis', 'organization': {'class': 'OTHER', 'fullName': 'Mahidol University'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'Si134/2008'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'curcuma domestica', 'description': '1,500 mg/day (oral) divided into 3 times for 28 days', 'interventionNames': ['Drug: Curcuma domestica extracts']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Ibuprofen', 'description': '1,200 mg/day (oral) divided into 3 times for 28 days', 'interventionNames': ['Drug: Ibuprofen']}], 'interventions': [{'name': 'Curcuma domestica extracts', 'type': 'DRUG', 'otherNames': ['Curcumin'], 'description': '1,500 mg per day (oral)divided into 3 times for 28 days', 'armGroupLabels': ['curcuma domestica']}, {'name': 'Ibuprofen', 'type': 'DRUG', 'otherNames': ['Brufen'], 'description': '1,200 mg/days (oral) divided into 3 times for 28 days', 'armGroupLabels': ['Ibuprofen']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10700', 'city': 'Bangkok', 'country': 'Thailand', 'facility': 'Faculty of Medicine Siriraj Hospital, Mahidol University', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}, {'zip': '50200', 'city': 'Chiang Mai', 'country': 'Thailand', 'facility': 'Faculty of Medicine, Chiang Mai University', 'geoPoint': {'lat': 18.79038, 'lon': 98.98468}}, {'city': 'KhonKaen', 'country': 'Thailand', 'facility': 'KhonKaen University Hospital'}, {'zip': '83000', 'city': 'Phuket', 'country': 'Thailand', 'facility': 'VachiraPhuket Hospital', 'geoPoint': {'lat': 7.89059, 'lon': 98.3981}}, {'city': 'Ratchaburi', 'country': 'Thailand', 'facility': 'Rajburi Hospital', 'geoPoint': {'lat': 13.53671, 'lon': 99.81712}}, {'city': 'Songkhla', 'country': 'Thailand', 'facility': 'Songkla Hospital', 'geoPoint': {'lat': 7.19882, 'lon': 100.5951}}], 'overallOfficials': [{'name': 'Vilai - Kuptniratsaikul, MD.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mahidol University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mahidol University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Research Council of Thailand', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Vilai Kuptniratsaikul', 'investigatorAffiliation': 'Mahidol University'}}}}