Ignite Creation Date:
2025-12-24 @ 2:22 PM
Ignite Modification Date:
2025-12-28 @ 10:24 AM
Study NCT ID:
NCT04607759
Status:
COMPLETED
Last Update Posted:
2021-09-17
First Post:
2020-10-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Trial on the Articular Pain With a Cucumber Supplement in Patients Diagnosed With Arthrosis
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': 'D019587', 'term': 'Dietary Supplements'}], 'ancestors': [{'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2021-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-16', 'studyFirstSubmitDate': '2020-10-15', 'studyFirstSubmitQcDate': '2020-10-23', 'lastUpdatePostDateStruct': {'date': '2021-09-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Pain from baseline at 8 weeks', 'timeFrame': 'The pain will be measured by a scale twice, at the beginning and at the end of the study (after an 8 week consumption).', 'description': 'Visual analog scale from 0 to 10. The higher the value, the more pain.'}], 'secondaryOutcomes': [{'measure': 'Change in concomitant analgesic medication', 'timeFrame': 'Twice, once at the beginning of the trial in basal conditions and once at the end after 8 weeks of consumption.', 'description': 'The change in the need for the use of analgesic medications will be evaluated.'}, {'measure': 'Quality of life test: WOMAC test', 'timeFrame': 'it will be measured twice, once at baseline or at the end of the study after 8 weeks of use', 'description': 'The quality of life of the subjects will be measured with the WOMAC test. It is a 24-item test that will measure the degree of pain: nothing, little, enough, a lot, and a lot, when performing activities in daily life.'}, {'measure': 'Functional test', 'timeFrame': 'Twice, once at the beginning of the trial in basal conditions and once at the end after 8 weeks of consumption.', 'description': 'The balance and mobility of the subjects will be measured with the Timed Up and Go Test'}, {'measure': 'Muscle function', 'timeFrame': 'Twice, once at the beginning of the trial in basal conditions and once at the end after 8 weeks of consumption.', 'description': 'Isokinetic dynamometry.'}, {'measure': 'Inflammatory state IL-b', 'timeFrame': 'Twice, once at the beginning of the trial in basal conditions and once at the end after 8 weeks of consumption.', 'description': 'It is a blood test that measures cartilage degradation'}, {'measure': 'Cartilage metabolism', 'timeFrame': 'Twice, once at the beginning of the trial in basal conditions and once at the end after 8 weeks of consumption.', 'description': 'It is a blood test that measures cartilage degradation'}, {'measure': 'Liver safety variables', 'timeFrame': 'Twice, once at the beginning of the trial in basal conditions and once at the end after 8 weeks of consumption.', 'description': 'It is a blood test that measures the presence of some enzymes, proteins and bilirubin in the blood, with the aim of determining if there is any alteration in the liver. Enzyme GPT, GOT, Gamma GT, LDH, alkaline phosphatase and bilirubin (UI/L)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Osteoarthritis']}, 'descriptionModule': {'briefSummary': 'Randomized, controlled, double-blind clinical trial of two parallel branches to analyze the efficacy of a supplement extracted from the cucumber on the joint pain of patients diagnosed with osteoarthritis.', 'detailedDescription': 'The subjects that meet the selection criteria will make a total of two visits to the research laboratory and will carry out the pre-established tests in the protocol. Subsequently, a statistical analysis will be carried out with the variables measured in the study to obtain results.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age over 40 years.\n* Subjects diagnosed with osteoarthritis with functional grades I-III according to the modified criteria of the American College of Rheumatology.\n* Subjects must have persistent knee pain associated with osteoarthritis with a baseline score of at least 30 mm on the VAS pain assessment.\n* Subjects should not present narcotic drugs or steroidal anti-inflammatory drugs or immunosuppressants in their treatment.\n\nExclusion Criteria:\n\n* Serious or terminal illnesses.\n* Subjects currently taking glucosamine, chondroitin sulfate, collagen or hyaluronic infiltrations or any supplement indicated for joint health.\n* Subjects with chronic inflammatory diseases that affect the musculoskeletal system (rheumatoid arthritis, gout, pseudo-gout, Paget's disease, chronic pain syndrome, etc.).\n* Subjects with a body mass index above 32.\n* Pregnant or lactating women.\n* Inability to understand informed consent."}, 'identificationModule': {'nctId': 'NCT04607759', 'acronym': 'CUCART', 'briefTitle': 'Clinical Trial on the Articular Pain With a Cucumber Supplement in Patients Diagnosed With Arthrosis', 'organization': {'class': 'OTHER', 'fullName': 'Universidad Católica San Antonio de Murcia'}, 'officialTitle': 'Randomized Clinical Trial to Analyze the Efficacy of a Supplement Removed From Cucumber on the Articular Pain of Diagnosed Patients of Arthrosis', 'orgStudyIdInfo': {'id': 'UCAMCFE-00017'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental group (cucumber)', 'description': 'Consumption for 90 days of cucumber extract (20mg/day)\n\nTwo capsules a day orally for 90 days.', 'interventionNames': ['Dietary Supplement: nutraceutical']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'control group Placebo (sucrose)', 'description': 'Two capsules a day orally for 90 days.', 'interventionNames': ['Dietary Supplement: nutraceutical']}], 'interventions': [{'name': 'nutraceutical', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Subjects will consume two capsules for eight weeks', 'armGroupLabels': ['Experimental group (cucumber)', 'control group Placebo (sucrose)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30107', 'city': 'Murcia', 'country': 'Spain', 'facility': 'Catholic University of Murcia', 'geoPoint': {'lat': 37.98704, 'lon': -1.13004}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad Católica San Antonio de Murcia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Francisco Javier López Román', 'investigatorAffiliation': 'Universidad Católica San Antonio de Murcia'}}}}