Health Condition 1: H618- Other specified disorders of external ear
Conditions
Interventions
Control Intervention1: CLOTRIMAZOLE CREAM VS CLOTRIMAZOLE EAR DROPS: EAC Cleaning and Debridement:
All patients will undergo cleaning and debridement of the External Auditory Canal (EAC) prior to tre
Sponsors
Hind Institute of Medical Sciences
Eligibility
Inclusion criteria
Inclusion criteria: Diagnosis: Confirmed otomycosis with positive fungal culture or microscopy. Age: Adults aged 18 years to 50 years. Symptom Duration: Symptoms present for at least [duration, e.g., 2 weeks]. Ear Condition: Active otomycosis with itching, discharge, and/or pain. Compliance: Ability to adhere to the treatment protocol. Informed Consent: Written informed consent obtained. Contraindications: No known hypersensitivity to clotrimazole. General Health: Overall good health with no severe concurrent ear conditions. Antifungal Treatments: No recent use of other antifungal treatments within [duration, e.g., 4 weeks].
Exclusion criteria
Exclusion criteria: Non-Fungal Ear Infections: Diagnosis of other ear infections or significant ear pathologies. Hypersensitivity: Known allergy to clotrimazole or its components. Concurrent Antifungal Therapy: Recent use of other antifungal treatments. Immunocompromised Conditions: Conditions affecting immune function. Recent Ear Surgery: Recent ear surgery or trauma. Pregnancy and Breastfeeding: Pregnant or breastfeeding women. Severe Medical Conditions: Severe or uncontrolled medical conditions. Inability to Follow Protocol: Inability to comply with treatment and follow-up. Concurrent Participation in Another Study: Participation in other studies that may interfere. Other Contraindications: Any other factors posing risk or affecting study results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical cure will be assessed through otoscopic examination and symptom evaluation, including the resolution of ear itching, discharge, and redness. Measurements will be taken at baseline and after 4 weeks of treatment.Timepoint: 1 week | — |
Secondary
| Measure | Time frame |
|---|---|
| Reduction in fungal load. Improvement in patient-reported symptoms. Treatment tolerability & side effects. Time to resolution of symptoms.Timepoint: 4 weeks | — |
Countries
India
Contacts
Public ContactRijul
Hind Institute of Medical Sciences, Sitapur
Outcome results
None listed