Ignite Creation Date:
2025-12-24 @ 11:45 PM
Ignite Modification Date:
2025-12-25 @ 9:38 PM
Study NCT ID:
NCT06229951
Status:
COMPLETED
Last Update Posted:
2024-12-24
First Post:
2024-01-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Hydrolyzed Collagen and Undenatured Collagen Type II in OA Knee
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': 'D003094', 'term': 'Collagen'}], 'ancestors': [{'id': 'D001704', 'term': 'Biopolymers'}, {'id': 'D011108', 'term': 'Polymers'}, {'id': 'D046911', 'term': 'Macromolecular Substances'}, {'id': 'D016326', 'term': 'Extracellular Matrix Proteins'}, {'id': 'D012596', 'term': 'Scleroproteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, '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': 68}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2024-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-19', 'studyFirstSubmitDate': '2024-01-16', 'studyFirstSubmitQcDate': '2024-01-25', 'lastUpdatePostDateStruct': {'date': '2024-12-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain (VNRS)', 'timeFrame': '12 weeks', 'description': 'Pain level (verbal numerical rating scale :VNRS) - 0 is no pain and 10 is the worst pain'}], 'secondaryOutcomes': [{'measure': 'Knee and Osteoarthritis Outcome Score (KOOS)', 'timeFrame': '12 weeks', 'description': 'Knee and Osteoarthritis Outcome Score (KOOS) - 100 indicates the best possible results and 0 the worst outcome'}, {'measure': 'Rescue medication', 'timeFrame': '12 weeks', 'description': 'Amount of pain medication intake'}, {'measure': 'Patient satisfaction', 'timeFrame': '12 weeks', 'description': 'Patient satisfaction (verbal numerical rating scale :VNRS) - (0-10; 0=worst and 10=best)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Osteoarthritis', 'Collagen supplement'], 'conditions': ['Osteo Arthritis Knee']}, 'referencesModule': {'references': [{'pmid': '40897777', 'type': 'DERIVED', 'citation': 'Yuenyongviwat V, Anusitviwat C, Tuntarattanapong P, Hongnaparak T, Iamthanaporn K. Efficacy of combined undenatured type II collagen and hydrolysed collagen supplementation in knee osteoarthritis: a randomised controlled trial. Sci Rep. 2025 Sep 2;15(1):32313. doi: 10.1038/s41598-025-17505-0.'}]}, 'descriptionModule': {'briefSummary': 'Randomized controlled trial\n\nTargeted patients who come to receive treatment for osteoarthritis that meets the research indications will be assigned to a random group by the box of 4 randomization method, with a sequence that is randomly generated by a computer. The groups are divided into two groups:\n\nGroup 1: Patients who have taken 480 mg of hydrolyzed collagen and 20 mg of undenatured type II collagen\n\nGroup 2: Control patients will take placebo\n\nPrimary outcome : Pain level'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age: 50-80 years old\n* Medial compartment knee osteoarthritis\n* Kellgren and Lawrence classification stage 2 -3\n* Able to walk without walking aid\n\nExclusion Criteria:\n\n* History of knee surgery on the study side\n* History of intra-articular steroid injection within 6 months prior to study entry\n* Systemic arthritis conditions\n* Degenerative neurological and muscular conditions in the lower extremities\n* Chronic kidney disease with CrCl \\< 30 ml/min (glomerular filtration rate \\<60 mL/min/1.73 m2)'}, 'identificationModule': {'nctId': 'NCT06229951', 'briefTitle': 'Hydrolyzed Collagen and Undenatured Collagen Type II in OA Knee', 'organization': {'class': 'OTHER', 'fullName': 'Prince of Songkla University'}, 'officialTitle': 'Efficacy of Hydrolyzed Collagen and Undenatured Collagen Type II in Alleviating Pain in Patients With Knee Osteoarthritis', 'orgStudyIdInfo': {'id': '66-304-11-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Collagen supplement group', 'description': 'Patients who have taken 480 mg of hydrolyzed collagen and 20 mg of undenatured type II collagen (in one tablet) 2 tabs a day', 'interventionNames': ['Dietary Supplement: Collagen']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control group', 'description': 'Control patients will take placebo 2 tabs a day', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Collagen', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Patients who have taken 480 mg of hydrolyzed collagen and 20 mg of undenatured type II collagen (in one tablet) 2 tabs a day', 'armGroupLabels': ['Collagen supplement group']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Control patients will take placebo 2 tabs a day.', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90110', 'city': 'Hat Yai', 'state': 'Changwat Songkhla', 'country': 'Thailand', 'facility': 'Prince of Songkla University', 'geoPoint': {'lat': 7.00836, 'lon': 100.47668}}]}, 'ipdSharingStatementModule': {'url': 'https://osf.io', 'infoTypes': ['STUDY_PROTOCOL', 'CSR'], 'timeFrame': 'Data will become available and for 1 year after publication.', 'ipdSharing': 'YES', 'accessCriteria': 'Open Science Framework (OSF)'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Prince of Songkla University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Varah Yuenyongviwat', 'investigatorAffiliation': 'Prince of Songkla University'}}}}