| CTRI Number |
CTRI/2024/09/074250 [Registered on: 24/09/2024] Trial Registered Prospectively |
| Last Modified On: |
02/06/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effectiveness of Clotrimazole Cream vs. Ear Drops in Treating Otomycosis |
|
Scientific Title of Study
|
Comparing the Therapy of Otomycosis Using Clotrimazole Cream versus Clotrimazole Ear Drops: A RANDOMIZED CONTROLLED CLINICAL TRIAL |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Syed Mohd Ahmad |
| Designation |
Associate Professor |
| Affiliation |
Hind Institute of medical sciences |
| Address |
Department Of ENT, OPD- 8,9,10,11,12, Hind Institute of Medical Sciences, Sitapur
Mau
UTTAR PRADESH
261303
India |
| Phone |
|
| Fax |
|
| Email |
dr_ahmad123@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Rijul |
| Designation |
Junior Resident |
| Affiliation |
Hind Institute of Medical Sciences, Sitapur |
| Address |
Department Of ENT, OPD- 8,9,10,11,12, Hind Institute of Medical Sciences, Sitapur
Mau
UTTAR PRADESH
261303
India |
| Phone |
9992491209 |
| Fax |
|
| Email |
kuchurijul@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rijul |
| Designation |
Junior Resident |
| Affiliation |
Hind Institute of Medical Sciences, Sitapur |
| Address |
Department Of ENT, OPD- 8,9,10,11,12, Hind Institute of Medical Sciences, Sitapur
UTTAR PRADESH
261303
India |
| Phone |
9992491209 |
| Fax |
|
| Email |
kuchurijul@gmail.com |
|
|
Source of Monetary or Material Support
|
| Hind Institute of Medical Sciences, Sitapur |
|
|
Primary Sponsor
|
| Name |
Hind Institute of Medical Sciences |
| Address |
Hind Institute of Medical Sciences, Mau, Ataria, Sitapur. Uttar Pradesh, India. 261303 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rijul |
Hind Institute of Medical Sciences |
Department Of ENT, OPD- 8,9,10,11,12.
Sitapur
UTTAR PRADESH |
9992491209
kuchurijul@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL HUMAN ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H618||Other specified disorders of external ear, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
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 treatment.
Group A Treatment:
Clotrimazole cream will be applied to the patients in Group A using a sterile, fresh 5 ml syringe.
The cream will be left in the EAC for 7 days.
After 7 days, the cream residue will be removed from the EAC, and the otic conditions will be re-evaluated.
Group B Treatment:
Patients in Group B will be instructed to apply Clotrimazole solution, 4 drops every 6 hours for 7 days.
After 7 days, the otic conditions will be re-evaluated.
Ideal Clinical Outcome
Symptom Resolution:
The ideal clinical result will be an asymptomatic patient with a clean and dry EAC, confirmed through microscopic examination.
Further Actions if Infection Persists:
If the infection continues, the EAC will be cleaned again.
A second treatment with the same drug will be administered.
Dry ear care and avoidance of identified predisposing factors will be advised to the patients.
Assessment of Improvement
Weekly Evaluation:
The degree of improvement will be assessed by comparing symptoms and findings from physical examinations on a weekly basis for 4 weeks.
Post-Treatment Evaluation:
One week after completing the treatment, a final assessment will be conducted to determine if the infection has resolved.
The resolution of symptoms and the cleanliness and dryness of the EAC will be confirmed through microscopic examination.
Monitoring for Relapse:
Any relapse or recurrence of symptoms will be addressed promptly.
This may include repeating the treatment and further evaluation of potential predisposing factors. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
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]. |
|
| ExclusionCriteria |
| Details |
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. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 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. |
1 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Reduction in fungal load.
Improvement in patient-reported symptoms.
Treatment tolerability & side effects.
Time to resolution of symptoms. |
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
25/09/2024 |
| 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="0"
Months="9"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
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
Modification(s)
|
Recruitment Status SummaryStudy Title- Clotrimazole Cream versus Ear Drops for Otomycosis - A RANDOMIZED TRIAL
Date- 02/06/2025]
Principal Investigator- DR. SYED MOHD AHMAD
Institution- HIND INSTITUTE OF MEDICAL SCIENCES
|