[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100600326":3},{"organization":4,"outcomesModule":7,"designInfo":27,"detailedDescription":30,"studyPopulation":30,"armGroups":37,"interventions":57,"overallOfficials":74,"centralContacts":83,"locations":30,"responsibleParty":92,"collaborators":30,"id":94,"slug":30,"hasResults":95,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":30,"eligibilityCriteria":99,"healthyVolunteers":95,"sex":100,"minAge":101,"maxAge":102,"enrollmentInfo":103,"targetDuration":30,"studyType":106,"phases":107,"briefSummary":109,"conditions":110,"keywords":112,"overallStatus":117,"whyStopped":30,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":30},{"fullName":5,"class":6},"Faculty of Medicine, Sousse","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":22},[9],{"measure":10,"description":11,"timeFrame":12},"Pain intensity","measured using the Visual Analog Scale (VAS), a 10-cm line anchored by \"no pain\" (0) and \"worst imaginable pain\" (10). VAS scores will be recorded at each clinical visit during the intervention period.","At each clinical visit during the intervention period (three times a week during 6 weeks).",[14,18],{"measure":15,"description":16,"timeFrame":17},"Functional knee status","assessed using the KOOS-Child questionnaire, covering five subscales (pain, symptoms, activities of daily living, sport\u002Frecreation function, and knee-related quality of life). Scores range from 0 (extreme dysfunction) to 100 (no symptoms).","Assessments will be done at baseline and after 6 weeks.",{"measure":19,"description":20,"timeFrame":21},"Return to sport","defined as the number of days post-treatment needed to resume regular athletic activity.","6 weeks",[23],{"measure":24,"description":25,"timeFrame":26},"Adverse events","Adverse events (skin reactions, discomfort, or other clinical complaints) will be recorded systematically.","At each follow-up visit during 6 weeks",{"allocation":28,"interventionModel":29,"interventionModelDescription":30,"primaryPurpose":31,"observationalModel":30,"timePerspective":30,"maskingInfo":32},"RANDOMIZED","PARALLEL",null,"TREATMENT",{"masking":33,"maskingDescription":30,"whoMasked":34},"DOUBLE",[35,36],"PARTICIPANT","OUTCOMES_ASSESSOR",[38,44,51],{"label":39,"type":40,"description":41,"interventionNames":42},"Urtica dioica cataplasm","EXPERIMENTAL","Topical application of Urtica dioica cataplasm",[43],"Other: Urtica dioica cataplasm",{"label":45,"type":46,"description":47,"interventionNames":48},"Standard Care Group","ACTIVE_COMPARATOR","Oral vitamin D supplementation and physical rest",[49,50],"Drug: Vitamin D","Behavioral: Resting conditions",{"label":52,"type":53,"description":54,"interventionNames":55},"Placebo","PLACEBO_COMPARATOR","Topical application of a placebo cataplasm",[56],"Other: Placebo",[58,61,64,69],{"type":6,"name":39,"description":59,"armGroupLabels":60,"otherNames":30},"Participants will receive a warm Urtica dioica cataplasm applied topically on the affected knee, once daily for 60 minutes, three times per week (on alternate days) over a 6-week period.",[39],{"type":6,"name":52,"description":62,"armGroupLabels":63,"otherNames":30},"Participants will receive a placebo cataplasm, matched in texture, color, and odor to the active treatment. The placebo is inert and safe for pediatric topical use.",[52],{"type":65,"name":66,"description":67,"armGroupLabels":68,"otherNames":30},"DRUG","Vitamin D","Participants will receive oral vitamin D.",[45],{"type":70,"name":71,"description":72,"armGroupLabels":73,"otherNames":30},"BEHAVIORAL","Resting conditions","Reduction in physical activity based on orthopedic advice.",[45],[75,79],{"name":76,"affiliation":77,"role":78},"Amira Zairi","Department of Biochemistry, Faculty of Medicine of Sousse, University of Sousse, Tunisia","STUDY_DIRECTOR",{"name":80,"affiliation":81,"role":82},"Sahbi El Mtaoua","Department of Physical Medicine and Rehabilitation, Hospital Ibn Jazzar of Kairouan, University of Sousse, Tunisia","PRINCIPAL_INVESTIGATOR",[84,89],{"name":85,"role":86,"phone":87,"phoneExt":30,"email":88},"Amira Zairi, Pr.","CONTACT","+21698424285","zairi_amira@yahoo.fr",{"name":90,"role":86,"phone":30,"phoneExt":30,"email":91},"Hana Nasrallah, PhD","hananasrallah.hn@gmail.com",{"type":82,"investigatorFullName":76,"investigatorTitle":93,"investigatorAffiliation":5,"oldNameTitle":30,"oldOrganization":30},"Professor","100600326",false,"NCT07096037","Safety and Efficacy of Urtica Dioica Cataplasm in the Management of Osgood-Schlatter Disease in Young Athletes","Evaluation of Safety and Efficacy of Urtica Dioica Cataplasm in the Management of Osgood-Schlatter Disease in Young Athletes: A Study Protocol for Randomized, Double-blind, Placebo Controlled Clinical Trial","Inclusion Criteria:\n\n* Healthy male children between 7 and 15 years of age\n* Active in regular sports practice (e.g., football)\n* Clinically confirmed diagnosis of OSD\n\nExclusion Criteria:\n\n* Known allergy to Urtica dioica\n* Presence of dermatological conditions or lesions on the knees\n* Recent use of anti-inflammatory medications\n* History of immune or chronic inflammatory diseases\n* Diagnosis of any other bone disorder","MALE","7 Years","15 Years",{"count":104,"type":105},90,"ESTIMATED","INTERVENTIONAL",[108],"NA","The primary objective of this clinical trial is to evaluate the efficacy and safety of a topical Urtica dioica cataplasm in managing knee pain and functional limitations in athletic children diagnosed with Osgood-Schlatter Disease. Efficacy will be assessed through changes in knee pain using the Visual Analog Scale (VAS) and functional outcomes using the Knee Injury and Osteoarthritis Outcome Score (KOOS). Three groups will be tested:\n\n* UDC Group: topical application of Urtica dioica cataplasm\n* Standard Care Group: oral vitamin D supplementation and physical rest\n* Placebo Group: topical application of a placebo cataplasm using Beta vulgaris subsp. cicla",[111],"Osgood-Schlatter Disease",[113,114,115,116],"Urtica dioica","Osgood-Schlatter disease","KOOS-Child","Visual Analogue Scale","NOT_YET_RECRUITING","2025-07-30",{"date":120,"type":121},"2025-08-01","ACTUAL",{"date":123,"type":105},"2025-09-01",{"date":125,"type":105},"2026-09-30",{"name":5,"class":6}]