Ignite Creation Date:
2025-12-25 @ 5:01 AM
Ignite Modification Date:
2025-12-26 @ 4:02 AM
Study NCT ID:
NCT05089318
Status:
COMPLETED
Last Update Posted:
2023-04-12
First Post:
2021-10-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of Flexofytol® PLUS in Hand Joint Chronic Dyscomfort.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 239}, 'targetDuration': '12 Weeks', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2021-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-11', 'studyFirstSubmitDate': '2021-10-11', 'studyFirstSubmitQcDate': '2021-10-11', 'lastUpdatePostDateStruct': {'date': '2023-04-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain using a Numerical Rating Scale (NRS)', 'timeFrame': '84 days', 'description': 'Change from baseline of the mean pain over the last 48 hours evaluated by the patient on a 0 to 10 scale ( 0= no pain and 10=maximal pain)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hand joint pain', 'curcumin', 'boswellia serrata', 'support to standard treatment'], 'conditions': ['Hand Joint Discomfort']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the effect of curcuminoids and Boswellia serrata extracts combination (Flexofytol PLUS) in support to standard treatments during a 12-weeks period on hand pain on people with chronic hand joint discomfort.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '45 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'adults above 45 years with chronic hand joint discomfort', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Older dan 45 years old,\n* With hand joint chronic discomfort,\n* Regularly uses of paracetamol or NSAIDs to manage pain,\n* Painful symptoms must have been present for more than 6 months,\n* The patient assesses their pain on a visual pain scale and must be greater than 4 out of 10 over the last 48 hours.\n\nExclusion Criteria:\n\n* Related to previous and associated treatments:\n\n * Corticosteroids injection in the 3 previous months, whatever the joint concerned,\n * Use of Slow-acting drugs for OA and/or dietary supplements taken within less than 6 months prior to the study (ex: chondroitin sulfate, diacerein, soy and avocado unsaponifiables, oxaceprol, granions de cuivre, glucosamine, phytotherapy or homeopathy for hand joint discomfort..),\n * Anticoagulant (coumarinic) treatment and heparin,\n * General corticotherapy in the 3 previous months,\n * Contraindication to paracetamol, curcumin, boswellia and NSAID's.\n* Related to associated pathologies:\n\n * Patient suffering from serious associated illness (liver failure, kidney failure, non-controlled cardiovascular diseases...),\n * The patient has rheumatoid arthritis or gout,\n * The patient has a bile obstruction.\n* Related to patient:\n\n * Pregnant or breastfeeding women."}, 'identificationModule': {'nctId': 'NCT05089318', 'briefTitle': 'Evaluation of Flexofytol® PLUS in Hand Joint Chronic Dyscomfort.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Tilman S.A.'}, 'officialTitle': 'Curcuminoids and Boswellia Serrata Extracts Combination Decreases Hand Joint Discomfort : Results From a Belgian Real-Life Experience', 'orgStudyIdInfo': {'id': 'FLEXOPAM'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Flexofytol PLUS', 'type': 'DIETARY_SUPPLEMENT', 'description': '2 tablets in the morning and in the evening for minimum 6 weeks.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '4100', 'city': 'Boncelles', 'state': 'Liège', 'country': 'Belgium', 'facility': 'Yves Henrotin', 'geoPoint': {'lat': 50.57108, 'lon': 5.53625}}, {'zip': '4100', 'city': 'Boncelles', 'country': 'Belgium', 'facility': 'Yves Henrotin', 'geoPoint': {'lat': 50.57108, 'lon': 5.53625}}], 'overallOfficials': [{'name': 'Yvan Dierckxsens', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Tilman S.A.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tilman S.A.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}