Nanoparticle-Based Prunus Salicina Extract vs. Clotrimazole for Otomycosis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age16-80
SponsorDeraya University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age between 16-80 years.
Confirmed clinical diagnosis of otomycosis via otoscopic examination (visible fungal elements such as hyphae, spores, curdy precipitates).
Willing and able to provide informed consent.
Disqualifiers
Otitis media, malignant otitis externa, chronic mucosal ear discharge.
Previous ear surgery or anatomical anomalies.
Systemic antifungal or corticosteroid therapy within two weeks prior.
Pregnancy or lactation.
Trial design
Design model
Parallel
Treatments tested in this trial
Group A
DrugClotrimazole 1% ear drops: Aqueous solution of 200 mg clotrimazole in sterile saline (9 mg/mL NaCl). Drops applied to affected ear canal as per standard clinical practice for 7 days.
Group B
DrugPrunus salicina Extract Drops: Aqueous solution (1:100 w/v) of Prunus salicina methanolic extract in sterile saline (9 mg/mL NaCl). Drops applied to affected ear canal for 7 days.
Group C
DrugChitosan 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.
Treatment groups
180 Participants
are divided into 3 treatment groupsGroup A: Group A: Clotrimazole 1%Active comparator 1 intervention
Group B: Group B: Prunus salicina Extract DropsExperimental treatment 1 intervention
Group C: Group C: Prunus salicina Nanoparticle DropsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Day 14 (end of treatment)2
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/sign scores with negative fungal culture. Moderate Response: 50-74% reduction with partial symptom relief or pending culture result. Poor Response: \<50% improvement or persistent/worsening symptoms and positive fungal culture.
Time frame
Day 14Secondary outcomes
1
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.
Time frame
Days 0, 3, 5, 7, and 142
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.
Time frame
Days 0, 3, 5, 7, and 143
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.
Time frame
Day 0 and Day 144
Recurrence Rate
Proportion of participants with reappearance of clinical symptoms and/or a positive fungal culture after initial clinical cure, assessed via clinical examination and fungal culture.
Time frame
2 weeks post treatmentSponsors and contacts
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Source ClinicalTrials.gov