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CTRI Number  CTRI/2025/12/098562 [Registered on: 05/12/2025] Trial Registered Prospectively
Last Modified On: 27/11/2025
Post Graduate Thesis  Yes 
Type of Trial  PMS 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Treatment of fungal ear infection in adults using either clotrimazole ear drops or fluconazole ear drops  
Scientific Title of Study   Comparative Evaluation of Efficacy and safety of clotrimazole versus Fluconazole in the management of Otomycosis 
Trial Acronym  NIL  
Secondary IDs if Any  
Secondary ID  Identifier 
NIL   NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sarayu kurpati 
Designation  Junior Resident 
Affiliation  All india institute of medical sciences , bibinagar , telangana  
Address  Room on 38, opd block , department of oto-rhino laryngology and head and neck surgery AIIMS bibinagar

Nalgonda
TELANGANA
508126
India 
Phone  8179151926  
Fax    
Email  sarayukurpati@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Shrikrishna B H 
Designation  Additional professor , head of the department 
Affiliation  All india institute of medical sciences , bibinagar , telangana  
Address  Room on 38, opd block , department of oto-rhino laryngology and head and neck surgery AIIMS bibinagar

Nalgonda
TELANGANA
508126
India 
Phone  9880260238  
Fax    
Email  shrikrishna.ent@aiimsbibinagar.edu.in  
 
Details of Contact Person
Public Query
 
Name  Sarayu kurpati 
Designation  Junior Resident 
Affiliation  All india institute of medical sciences , bibinagar , telangana  
Address  Room on 38, opd block , department of oto-rhino laryngology and head and neck surgery AIIMS bibinagar


TELANGANA
508126
India 
Phone  8179151926  
Fax    
Email  sarayukurpati@gmail.com  
 
Source of Monetary or Material Support  
NIL  
 
Primary Sponsor  
Name  All india institute of medical sciences , bibinagar  
Address  AIIMS bibinagar, HMR rangapur village, bibinagar mandal, yadadri bhongir district, telangana , 508126 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Sarayu kurpati  All india institute of medical sciences , bibinagar , telangana  Room on 38, opd block , department of oto-rhino laryngology and head and neck surgery AIIMS bibinagar
Nalgonda
TELANGANA 
8179151926

sarayukurpati@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee ( AIIMS BBN- IEC)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H624||Otitis externa in other diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  clotrimazole group  patients will be advised to instill clotrimazole1% ear drops, 3 drops three times a day 
Comparator Agent  flucanazole group  patients will be instructed to use fluconazole drops, 3 drops three times a day in affected ear 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Clinical evidence of fungal otitis externa.
Immunocompetent patients.
 
 
ExclusionCriteria 
Details  1.Otomycosis associated with otitis media
2.Prior usage of topical antifungals.
3.Patients not consenting for participation.
4.Noncompliance with medication/follow-up.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Patient reported outcomes of symptoms based on validated scale and Mycological clearance by culture negativity  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 Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Post Marketing Surveillance 
Date of First Enrollment (India)   18/12/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

The protocol titled Comparative Evaluation of Efficacy and Safety of Clotrimazole Versus Fluconazole in the Management of Otomycosis A Prospective Randomized Study aims to address a significant clinical gap in the management of otomycosis a frequently encountered superficial fungal infection of the external auditory canal The infection is particularly common in tropical and humid regions and is caused predominantly by Aspergillus and Candida species Patients suffering from otomycosis often experience recurrent symptoms and due to varied success rates of available topical antifungals a consensus on the most effective agent in routine practice remains elusive Thus the present study is intended to rigorously compare the efficacy and side effect profiles of topical clotrimazole and fluconazole ear drops in hopes of facilitating more evidence based therapeutic decisions and improving patient outcomes Subjects eligible for this study are immunocompetent adults between 18 and 60 years of age who present to the ENT outpatient department at AIIMS Bibinagar Hyderabad with clinical features of otomycosis Rigorous inclusion and exclusion criteria will be employed exclusion will be extended to those with tympanic membrane perforation associated otitis media prior usage of topical antifungals and those unwilling to comply with study protocols Upon obtaining written informed consent 100 eligible patients will be randomized into two groups using a block randomization technique with concealed allocation Group A will receive clotrimazole 1 ear drops and Group B will be administered fluconazole 03 ear drops thrice daily for a duration of three weeksA comprehensive baseline assessment will be conducted consisting of otoscopic examination clinical evaluation and microbiological testing of ear swabs by KOH mount and fungal cultures Participants will be evaluated weekly for four weeks with extended follow up at one two and three months post treatment Symptom improvement will be systematically documented using validated scales and mycological clearance will be confirmed through laboratory protocols Both efficacy and treatment emergent side effects will be monitored meticulously Every measure will be taken to maximize patient comfort and maintain confidentiality minimizing risks by employing standard and proven topical therapies Any adverse events occurring during the study will be managed appropriately and without financial burden to the participant The primary objective is to discern whether either clotrimazole or fluconazole leads to superior symptomatic and mycological cure rates for otomycosis Secondary objectives include the assessment of treatment safety and identification of adverse effects related to each antifungal agent Data analysis will follow the intention to treat methodology employing robust statistical methods suitable for both categorical and continuous variables The anticipated benefits for study participants include rapid symptom relief and lower recurrence rates with the overarching community benefit of refining treatment standards for otomycosis Importantly there are no reported conflicts of interest or commercial stakes Adherence to all applicable national ethical and regulatory guidelines including those set forth by ICMR and GCP is assured In conclusion this protocol aims to provide pivotal practice changing data regarding the two most commonly employed antifungal treatments for otomycosis It has been designed to ensure scientific validity ethical rigor and patient safety The results will be communicated via peer reviewed publication and other appropriate forums thereby serving both academic and clinical communities Participants privacy and rights will be protected throughout and if successful the study may inform standard of care protocols for otomycosis at both national and global levels

 
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