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Nanoparticle-Based Prunus Salicina Extract vs. Clotrimazole for Otomycosis
Sponsor: Deraya University
Summary
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.
Official title: Comparative Efficacy of Nanoparticle-Based Prunus Salicina Methanolic Extract Drops Versus Standard Antifungal Therapy for Otomycosis: A Randomized Controlled Trial
Key Details
Gender
All
Age Range
16 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
180
Start Date
2025-07-15
Completion Date
2026-11-15
Last Updated
2026-10-09
Healthy Volunteers
No
Conditions
Interventions
Group A
Clotrimazole 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
Prunus 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
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.
Locations (1)
Minia University Hospital
Minya, Egypt