[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659753":3},{"organization":4,"outcomesModule":7,"designInfo":38,"detailedDescription":47,"studyPopulation":37,"armGroups":48,"interventions":66,"overallOfficials":37,"centralContacts":77,"locations":85,"responsibleParty":103,"collaborators":37,"id":105,"slug":106,"hasResults":107,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":37,"eligibilityCriteria":111,"healthyVolunteers":107,"sex":112,"minAge":113,"maxAge":114,"enrollmentInfo":115,"targetDuration":37,"studyType":118,"phases":119,"briefSummary":121,"conditions":122,"keywords":37,"overallStatus":88,"whyStopped":37,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":134},{"fullName":5,"class":6},"Deraya University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":37},[9,13],{"measure":10,"description":11,"timeFrame":12},"Mycological Clinical Cure Rate at Day 14","Proportion of participants achieving complete resolution of clinical signs and symptoms of otomycosis (pruritus, otalgia, otorrhea, and hearing impairment) AND a negative fungal culture. The primary analysis will test for superiority of each Prunus salicina formulation over clotrimazole. The anticipated absolute treatment effect used for study planning was 19 percentage points.","Day 14 (end of treatment)",{"measure":14,"description":15,"timeFrame":16},"Treatment Response Classification at Day 14","Categorical classification of treatment response based on reduction in total symptoms and sign scores combined with culture result. Good Response: ≥75% reduction in total symptom\u002Fsign scores with negative fungal culture. Moderate Response: 50-74% reduction with partial symptom relief or pending culture result. Poor Response: \\\u003C50% improvement or persistent\u002Fworsening symptoms and positive fungal culture.","Day 14",[18,22,25,29,33],{"measure":19,"description":20,"timeFrame":21},"Symptom Severity Score","Total symptom score measured using a standardized 4-point Likert scale (0 = none, 1 = mild, 2 = moderate, 3 = severe) for each symptom (pruritus, otalgia, otorrhea, hearing impairment, tinnitus, fullness). Summed to a total score.","Days 0, 3, 5, 7, and 14",{"measure":23,"description":24,"timeFrame":21},"Sign Severity Score","Total sign score objectively assessed via otoendoscopic examination of canal erythema, edema, discharge, and tympanic membrane congestion. Each sign graded on a 0-3 scale (0 = absent, 3 = severe). Summed to a total score.",{"measure":26,"description":27,"timeFrame":28},"Microbiological Clearance","Fungal and bacterial culture results from ear discharge collected at baseline and end of treatment. Mycological cure defined as a negative fungal culture.","Day 0 and Day 14",{"measure":30,"description":31,"timeFrame":32},"Recurrence Rate","Proportion of participants with reappearance of clinical symptoms and\u002For a positive fungal culture after initial clinical cure, assessed via clinical examination and fungal culture.","2 weeks post treatment",{"measure":34,"description":35,"timeFrame":36},"Number of Participants with Adverse Events","Incidence of treatment-emergent adverse events, including irritant dermatitis, headache, otalgia, and drug residue in the ear canal, assessed by the investigator at each visit.","Day 0 - Day 28",null,{"allocation":39,"interventionModel":40,"interventionModelDescription":41,"primaryPurpose":42,"observationalModel":37,"timePerspective":37,"maskingInfo":43},"RANDOMIZED","PARALLEL","Prospective, randomized, active-controlled, three-arm superiority trial","TREATMENT",{"masking":44,"maskingDescription":37,"whoMasked":45},"SINGLE",[46],"OUTCOMES_ASSESSOR","Otomycosis is a superficial fungal infection of the external auditory canal, predominantly caused by Aspergillus and Candida species. Topical antifungal agents, particularly 1% clotrimazole, are the mainstay of treatment; however, their effectiveness is suboptimal due to antifungal resistance, poor adherence, and short retention time of liquid formulations. Prunus salicina (Japanese Plum) fruits contain over 40 phenolic compounds with significant antifungal efficacy. Nanoparticle-based drug delivery systems have shown potential in enhancing drug retention and sustained release. This study compares three treatment arms over a 7-day treatment period with follow-up at 1 month. The primary hypothesis is that Prunus salicina formulations will demonstrate superiority over standard clotrimazole in achieving mycological clinical cure. An anticipated absolute treatment effect of 19 percentage points was used for study planning.",[49,55,61],{"label":50,"type":51,"description":52,"interventionNames":53},"Group A: Clotrimazole 1%","ACTIVE_COMPARATOR","Clotrimazole 1% ear drops: Aqueous solution of 200 mg clotrimazole in sterile saline (9 mg\u002FmL NaCl). Drops applied to affected ear canal as per standard clinical practice for 7 days.",[54],"Drug: Group A",{"label":56,"type":57,"description":58,"interventionNames":59},"Group B: Prunus salicina Extract Drops","EXPERIMENTAL","Prunus salicina Extract Drops: Aqueous solution (1:100 w\u002Fv) of Prunus salicina methanolic extract in sterile saline (9 mg\u002FmL NaCl). Drops applied to affected ear canal for 7 days.",[60],"Drug: Group B",{"label":62,"type":57,"description":63,"interventionNames":64},"Group C: Prunus salicina Nanoparticle Drops","Chitosan Nanoparticle Prunus salicina Extract Drops: Chitosan nanoparticles loaded with Prunus salicina extract (Ch-PS-NPs) prepared by ionotropic gelation. Drops applied to affected ear canal for 7 days.",[65],"Drug: Group C",[67,71,74],{"type":68,"name":69,"description":52,"armGroupLabels":70,"otherNames":37},"DRUG","Group A",[50],{"type":68,"name":72,"description":58,"armGroupLabels":73,"otherNames":37},"Group B",[56],{"type":68,"name":75,"description":63,"armGroupLabels":76,"otherNames":37},"Group C",[62],[78,83],{"name":79,"role":80,"phone":81,"phoneExt":37,"email":82},"Aliaa Hussien","CONTACT","01003041632","aliaagamal2622@gmail.com",{"name":84,"role":80,"phone":81,"phoneExt":37,"email":37},"Aliaa Hussein",[86],{"facility":87,"status":88,"city":89,"state":37,"zip":37,"country":90,"countryCode":91,"cosmosGeoPoint":92,"geoPoint":97,"contacts":98},"Minia University Hospital","RECRUITING","Minya","Egypt","EG",{"type":93,"coordinates":94},"Point",[95,96],30.75813,28.09193,{"lat":96,"lon":95},[99],{"name":100,"role":80,"phone":101,"phoneExt":102,"email":37},"Mostafa Nasr Zayed","01007905656","+20",{"type":104,"investigatorFullName":37,"investigatorTitle":37,"investigatorAffiliation":37,"oldNameTitle":37,"oldOrganization":37},"SPONSOR","100659753","nanoparticle-based-prunus-salicina-extract-vs-clotrimazole-for-otomycosis-100659753",false,"NCT07867223","Nanoparticle-Based Prunus Salicina Extract vs. Clotrimazole for Otomycosis","Comparative Efficacy of Nanoparticle-Based Prunus Salicina Methanolic Extract Drops Versus Standard Antifungal Therapy for Otomycosis: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Age between 16-80 years.\n* Confirmed clinical diagnosis of otomycosis via otoscopic examination (visible fungal elements such as hyphae, spores, curdy precipitates).\n* Willing and able to provide informed consent.\n\nExclusion Criteria:\n\n* Otitis media, malignant otitis externa, chronic mucosal ear discharge.\n* Previous ear surgery or anatomical anomalies.\n* Systemic antifungal or corticosteroid therapy within two weeks prior.\n* Pregnancy or lactation.\n* Concurrent bacterial infection.\n* Diabetes mellitus.","ALL","16 Years","80 Years",{"count":116,"type":117},180,"ESTIMATED","INTERVENTIONAL",[120],"NA","This randomized controlled superiority trial evaluates the anti-otomycotic efficacy of Prunus salicina methanolic extract in two formulations (standard drops and chitosan nanoparticle-based drops) compared to standard 1% clotrimazole drops in patients diagnosed with otomycosis.",[123,124],"Otomycosis","Antifungal Agents","2026-10-05",{"date":127,"type":128},"2026-10-09","ACTUAL",{"date":130,"type":128},"2025-07-15",{"date":132,"type":117},"2026-11-15",{"name":5,"class":6},1]