Ignite Creation Date:
2025-12-24 @ 9:17 PM
Ignite Modification Date:
2026-03-28 @ 9:02 AM
Study NCT ID:
NCT00992004
Status:
COMPLETED
Last Update Posted:
2010-05-07
First Post:
2009-10-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Efficacy of a Turmeric Extract (Arantal®) in Patients With Osteoarthritis of the Knee (Gonarthrosis).
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}, {'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}], 'ancestors': [{'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 280}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-05', 'completionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-05-06', 'studyFirstSubmitDate': '2009-10-07', 'studyFirstSubmitQcDate': '2009-10-07', 'lastUpdatePostDateStruct': {'date': '2010-05-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-10-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Patient's Assessment of Arthritis Pain using a Visual Analogue Scale (OA-Pain VAS)", 'timeFrame': '15 days'}], 'secondaryOutcomes': [{'measure': 'Kinetics of the analgesic effect by a variance analysis in repeated measures (Likert Scale)', 'timeFrame': '15 days'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Osteoarthritis, Knee', 'Osteoarthritis', 'Joint Diseases', 'Arthritis', 'Rheumatic Diseases'], 'conditions': ['Osteoarthritis, Knee']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the efficacy and the tolerance on 15 days of a turmeric extract (Arantal®) on pain related to gonarthrosis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patient is 40 through 80 years of age\n* Subject diagnosed with femorotibial osteoarthritis of the knee (diagnosed according to the clinical and radiologic criteria of ACR),\n* Patient's Assessment of Arthritis Pain measurement on the last 24 hours of at least 50 mm on VAS,\n* Patient has not received any NSAIDs within 72 hours and any analgesics within 24 hours,\n* Patients with chronic knee pain (i.e., knee pain at least every other day during the month preceding inclusion),\n* Patients with radiologic knee osteoarthritis (Kellgren-Lawrence grade 2-4, on radiography less than 12 months old),\n* Patients having signed the informed consent,\n* Patients capable of comprehend the study instructions.\n\nExclusion Criteria:\n\n* Related to the osteoarthritis pathology:\n\n * Osteoarthritis linked to a metabolic arthropathy: chondrocalcinosis already diagnosed or defined by calcium edging on at least one femorotibial joint space, gout...,\n * Predominant associated symptomatic femoropatellar osteoarthritis,\n * Chondromatosis or villonodular synovitis of the knee,\n * Recent trauma (\\< 1 month) of the knee responsible for the pain,\n * Knee joint effusion justifying an evacuation through puncturing,\n * Inflammatory flare (night pain, joint effusion) corresponding to a KOFUS score less than 7,\n * Pathology potentially interfering with the evaluation (metabolic inflammatory arthropathy, rheumatoid arthritis, lower limb radiculalgia, arthritis...),\n* Related to previous and associated treatments:\n\n * Corticosteroids injection in the previous month, whatever the joint concerned,\n * Hyaluronan injection in the evaluated knee during the previous 6 months,\n * Patient who took NSAID in the 72 hours prior to inclusion or Analgesics in the 24 hours prior to inclusion,\n * Slow-acting drugs for OA and/or dietary supplements taken within less than 3 months prior to the study product administration or for which the dose has been modified in the last three months (ex: chondroitin sulfate, diacerein, soy and avocado unsaponifiables, oxaceprol, granions de cuivre, glucosamine, phytotherapy for OA, homeopathy for OA...),\n * Anticoagulant treatment without gastric protection,\n * General corticotherapy,\n * Contraindication to paracetamol.\n* Related to associated pathologies:\n\n * Patient suffering from serious associated illness (liver failure, kidney failure, non-controlled cardiovascular diseases...),\n * Peptic ulcer.\n* Related to patients:\n\n * Pregnant or breastfeeding women\n * Pre-menopausal women with no contraception\n * Patients unable to write\n * Patients enrolled in a clinical trial in the previous 3 months\n * Patients under juristic protection or under guardianship."}, 'identificationModule': {'nctId': 'NCT00992004', 'briefTitle': 'Evaluation of the Efficacy of a Turmeric Extract (Arantal®) in Patients With Osteoarthritis of the Knee (Gonarthrosis).', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bioxtract SA'}, 'officialTitle': 'Comparative, Randomized, Double-blind, Placebo-controlled, Parallel Group Study, to Evaluate the Efficacy of a Turmeric Extract (Arantal®) Versus Placebo in Patients With Osteoarthritis of the Knee (Gonarthrosis).', 'orgStudyIdInfo': {'id': 'ARKOS'}, 'secondaryIdInfos': [{'id': '2009-A00174-53'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arantal®', 'description': 'Highly bioavailable turmeric extract (food supplement)', 'interventionNames': ['Dietary Supplement: Arantal® (highly bioavailable turmeric extract)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Same capsule without the active ingredients (only excipients)', 'interventionNames': ['Dietary Supplement: Arantal® (highly bioavailable turmeric extract)']}], 'interventions': [{'name': 'Arantal® (highly bioavailable turmeric extract)', 'type': 'DIETARY_SUPPLEMENT', 'description': '4 capsules a day, before breakfast', 'armGroupLabels': ['Arantal®', 'Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94000', 'city': 'Créteil', 'country': 'France', 'facility': 'Henri Mondor Hospital', 'geoPoint': {'lat': 48.79266, 'lon': 2.46569}}], 'overallOfficials': [{'name': 'Yves Henrotin, Pr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Liege - Bone and Cartilage Research Unit'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bioxtract SA', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Nukleus', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Dr Ingrid Jacquemond-Collet', 'oldOrganization': 'bioXtract SA'}}}}