Nctid:
NCT06229951
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000010003", "term"=>"Osteoarthritis"}, {"id"=>"D000020370", "term"=>"Osteoarthritis, Knee"}], "ancestors"=>[{"id"=>"D000001168", "term"=>"Arthritis"}, {"id"=>"D000007592", "term"=>"Joint Diseases"}, {"id"=>"D000009140", "term"=>"Musculoskeletal Diseases"}, {"id"=>"D000012216", "term"=>"Rheumatic Diseases"}], "browseLeaves"=>[{"id"=>"M4476", "name"=>"Arthritis", "relevance"=>"LOW"}, {"id"=>"M12926", "name"=>"Osteoarthritis", "asFound"=>"Osteo Arthritis", "relevance"=>"HIGH"}, {"id"=>"M22168", "name"=>"Osteoarthritis, Knee", "asFound"=>"Osteo Arthritis Knee", "relevance"=>"HIGH"}, {"id"=>"M13066", "name"=>"Pain", "relevance"=>"LOW"}, {"id"=>"M10621", "name"=>"Joint Diseases", "relevance"=>"LOW"}, {"id"=>"M12097", "name"=>"Musculoskeletal Diseases", "relevance"=>"LOW"}, {"id"=>"M15045", "name"=>"Rheumatic Diseases", "relevance"=>"LOW"}, {"id"=>"M6323", "name"=>"Collagen Diseases", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Musculoskeletal Diseases", "abbrev"=>"BC05"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"Skin and Connective Tissue Diseases", "abbrev"=>"BC17"}]}}, "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"=>"ESTIMATED", "count"=>68}}, "statusModule"=>{"overallStatus"=>"NOT_YET_RECRUITING", "startDateStruct"=>{"date"=>"2024-01-20", "type"=>"ESTIMATED"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-01", "completionDateStruct"=>{"date"=>"2025-03-30", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-01-25", "studyFirstSubmitDate"=>"2024-01-16", "studyFirstSubmitQcDate"=>"2024-01-25", "lastUpdatePostDateStruct"=>{"date"=>"2024-01-29", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-29", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2024-12-31", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Pain (VNRS)", "timeFrame"=>"first, 2 weeks, 6 weeks, 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"=>"first, 2 weeks, 6 weeks, 12 weeks", "description"=>"Knee and Osteoarthritis Outcome Score (KOOS) - 100 indicates the best possible results and 0 the worst outcome"}, {"measure"=>"Rescue medication", "timeFrame"=>"first, 2 weeks, 6 weeks, 12 weeks", "description"=>"Amount of pain medication intake"}, {"measure"=>"Patient satisfaction", "timeFrame"=>"first, 2 weeks, 6 weeks, 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"]}, "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"}, "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) twice a day", "interventionNames"=>["Dietary Supplement: Collagen"]}, {"type"=>"PLACEBO_COMPARATOR", "label"=>"Control group", "description"=>"Control patients will take placebo twice 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) twice a day", "armGroupLabels"=>["Collagen supplement group"]}, {"name"=>"Placebo", "type"=>"OTHER", "description"=>"Control patients will take placebo twice a day.", "armGroupLabels"=>["Control group"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"90110", "city"=>"Hat Yai", "state"=>"Songkhla", "country"=>"Thailand", "contacts"=>[{"name"=>"Varah Yuenyongviwat, M.D.", "role"=>"CONTACT", "email"=>"varah.y@psu.ac.th", "phone"=>"6674451601"}], "facility"=>"Prince of Songkla University", "geoPoint"=>{"lat"=>7.00836, "lon"=>100.47668}}], "centralContacts"=>[{"name"=>"Varah Yuenyongviwat, M.D.", "role"=>"CONTACT", "email"=>"varah.y@psu.ac.th", "phone"=>"6674451601"}]}, "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"=>"Associate Professor", "investigatorFullName"=>"Varah Yuenyongviwat", "investigatorAffiliation"=>"Prince of Songkla University"}}}}
