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Clinical trial

Efficacy of Pyodine Soaked Gelfoam vs Single Topical Application of Clotrimazole in Treatment of Otomycosis: a Randomized Controlled Clinical Trial

ID
Name
ZShabbir
Description
Background and Objectives To compare the efficacy of gel foam-soaked pyodine with a single topical application of clotrimazole ointment. Subjects and Methods This randomized controlled trial will include 90 patients presenting to ENT OPD with complaints of earache, watery ear discharge, pruritis, and ear blockage and will be clinically diagnosed as a case of otomycosis on otoscopy. The external auditory canal of the patient will be cleared of fungal debris via suction before treatment In Group A ear canal will be filled with 1% clotrimazole ointment by using an IV catheter and syringe and in Group B pyodine-soaked gel foam will be placed in the external auditory canal. The patients will be followed up on post-treatment days 7 and 14.
Trial arms
Trial start
2023-06-16
Estimated PCD
2023-12-15
Trial end
2023-12-31
Status
Completed
Phase
Early phase I
Treatment
Clotrimazole Cream
Single time application of clotrimazole ointment was done after aural toilet in external auditory canal via IV catheter
Arms:
Group A (clotrimazole ointment group)
Povidone-Iodine
Gelfoam soaked pyodine solution was placed in external auditory canal after aural toilet
Arms:
Group B(Povidone Iodine group)
Size
90
Primary endpoint
Treatment Response Based on Otoscopy
7th and 14th post treatment day
Eligibility criteria
Inclusion Criteria: * All patients with clinical diagnosis of otomycosis via otoscopy Exclusion Criteria: * Active CSOM * External auditory canal abnormalities * Patients on hearing aids
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}}, 'enrollmentInfo': {'count': 90, 'type': 'ACTUAL'}}
Updated at
2024-04-01

1 organization

2 products

1 indication

Organization
Rawalpindi Medical College
Product
Clotrimazole
Indication
Otomycosis
Product
Povidone-Iodine