Otomycosis Clinical Trial
Official title:
Efficacy of Pyodine Soaked Gelfoam vs Single Topical Application of Clotrimazole in Treatment of Otomycosis: a Randomized Controlled Clinical Trial
Verified date | March 2024 |
Source | Rawalpindi Medical College |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 90 |
Est. completion date | December 31, 2023 |
Est. primary completion date | December 15, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: - All patients with clinical diagnosis of otomycosis via otoscopy Exclusion Criteria: - Active CSOM - External auditory canal abnormalities - Patients on hearing aids |
Country | Name | City | State |
---|---|---|---|
Pakistan | Benazir Bhutto Hospital | Rawalpindi | Punjab/46000 |
Lead Sponsor | Collaborator |
---|---|
Rawalpindi Medical College |
Pakistan,
Chavan RP, Ingole SM, Kanchewad Resident GS. Single Topical Application of 1% Clotrimazole Cream in Otomycosis. Indian J Otolaryngol Head Neck Surg. 2023 Apr;75(Suppl 1):147-154. doi: 10.1007/s12070-022-03206-x. Epub 2022 Dec 8. — View Citation
Haq M, Deshmukh P. Review of Recurrent Otomycosis and Clotrimazole in Its Treatment. Cureus. 2022 Oct 9;14(10):e30098. doi: 10.7759/cureus.30098. eCollection 2022 Oct. — View Citation
Jwery AK. Various topical antifungal agents in otomycosis, which is the best? J Pak Med Assoc. 2021 Dec;71(Suppl 8)(12):S32-S34. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Treatment Response Based on Otoscopy | Good response Patients with a dry EAC and tympanic membrane intact with no fungal spores
Partial Response: Patients with scanty discharge but not completely dry EAC with no fungal spores No Response: Patients with unusually high EAC Exudation with fungal spores present |
7th and 14th post treatment day | |
Secondary | Condition of External Auditory Canal | Condition of External Auditory canal will be assessed via otoscop External auditory canal edema and erythema: Present or not Tympanic membrane congestion: Present or not Purulent discharge: Present or Not | 7th and 14th post treatment day |
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