Treatment of fungal ear infection in adults using either clotrimazole ear drops or fluconazole ear drops

Comparative Evaluation of Efficacy and safety of clotrimazole versus Fluconazole in the management of Otomycosis - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2025/12/098562

Enrollment

100

Registered

2025-12-05

Start date

Unknown

Completion date

Unknown

Last updated

2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: H624- Otitis externa in other diseases classified elsewhere

Interventions

Intervention1: clotrimazole group: patients will be advised to instill clotrimazole1% ear drops, 3 drops three times a day Control Intervention1: flucanazole group: patients will be instructed to use

Eligibility

Inclusion criteria

Inclusion criteria: Clinical evidence of fungal otitis externa. Immunocompetent patients.

Exclusion criteria

Exclusion criteria: 1.Otomycosis associated with otitis media 2.Prior usage of topical antifungals. 3.Patients not consenting for participation. 4.Noncompliance with medication/follow-up.

Design outcomes

Primary

Measure	Time frame
Patient reported outcomes of symptoms based on validated scale and Mycological clearance by culture negativityTimepoint: baseline: first visit to opd 1st week: PGI-I Scale,otoendoscopy 2nd week: PGI-I Scale,otoendoscopy, mycological clearance 3rd week : PGI-I Scale,otoendoscopy 4th week : PGI-I Scale,otoendoscopy, mycological clearance 2nd month: PGI-I Scale,otoendoscopy 3rd month : PGI-I Scale,otoendoscopy	—

Measure

Time frame

Patient reported outcomes of symptoms based on validated scale and Mycological clearance by culture negativityTimepoint: baseline: first visit to opd 1st week: PGI-I Scale,otoendoscopy 2nd week: PGI-I Scale,otoendoscopy, mycological clearance 3rd week : PGI-I Scale,otoendoscopy 4th week : PGI-I Scale,otoendoscopy, mycological clearance 2nd month: PGI-I Scale,otoendoscopy 3rd month : PGI-I Scale,otoendoscopy

—

Secondary

Measure	Time frame
NILTimepoint: NIL	—

Countries

India

Contacts

Public ContactSarayu kurpati

All india institute of medical sciences , bibinagar , telangana

shrikrishna.ent@aiimsbibinagar.edu.in9880260238

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026