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CTRI Number  CTRI/2026/03/106970 [Registered on: 27/03/2026] Trial Registered Prospectively
Last Modified On: 27/03/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A Clinical Trial to study the effects of two drugs, dexamethasone and methylprednisolone in patients with Sudden sensorineural hearing loss 
Scientific Title of Study   Comparison of Efficacy of Intratympanic Methylprednisolone & Intratympanic Dexamethasone in the treatment of Sudden Sensorineural Hearing loss- A Randomized controlled 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  Muskan Rao 
Designation  Junior Resident 
Affiliation  All India Institute of Medical Sciences, Jammu 
Address  Room no. 113, Department of ENT, All India Institute of Medical sciences, Jammu

Jammu
JAMMU & KASHMIR
184120
India 
Phone  9671249762  
Fax    
Email  muskan.rao@aiimsjammu.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Darwin Kaushal 
Designation  Additional Professor 
Affiliation  All India Institute of Medical Sciences, Jammu 
Address  Room no. 112, Department of ENT, All India Institute of Medical sciences, Jammu

Jammu
JAMMU & KASHMIR
184120
India 
Phone  8003647999  
Fax    
Email  darwin.kaushal@aiimsjammu.edu.in  
 
Details of Contact Person
Public Query  
Name  Muskan Rao 
Designation  Junior Resident 
Affiliation  All India Institute of Medical Sciences, Jammu 
Address  Room no. 113, Department of ENT, All India Institute of Medical sciences, Jammu

Jammu
JAMMU & KASHMIR
184120
India 
Phone  9671249762  
Fax    
Email  muskan.rao@aiimsjammu.edu.in  
 
Source of Monetary or Material Support  
Nil 
 
Primary Sponsor  
Name  AIIMS Vijaypur Jammu 
Address  Room no. 113, Department of ENT, All India Institute of Medical Sciences, Jammu, Jammu & Kashmir, 184120 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
Nil  Nil 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Muskan Rao  AIIMS, Jammu  Room no. 113, Department of ENT, All India Institute of Medical sciences, Jammu, 184120
Jammu
JAMMU & KASHMIR 		 09671249762

muskan.rao@aiimsjammu.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee, AIIMS Jammu  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H839||Unspecified disease of inner ear,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Intratympanic Injections  Intratympanic Dexamethasone Injections will be given in patients with sudden sensorineural hearing loss 
Intervention  Intratympanic methylprednisolone injection  Intratympanic Methylprednisolone Injections will be given in patients with sudden sensorineural hearing loss 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Patient diagnosed with Sudden SNHL,Sudden sensorineural hearing loss is most often defined as sensorineural hearing loss of 30dB or greater over at least three contiguous audiometric frequencies presenting within duration of 6 months.
Patients aged 18–60 years.
 
 
ExclusionCriteria 
Details  Patient with conductive or mixed hearing loss

Patient with presence of pre-existing otologic conditions such as chronic otitis media, Meniere’s disease, or other inner ear pathologies.

Patients with a documented allergy or hypersensitivity to methylprednisolone, dexamethasone, or other corticosteroids.
 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To assess the improvement in Pure Tone Audiometry after treatment with intratympanic methylprednisolone versus dexamethasone.  To assess the improvement in Pure Tone Audiometry after treatment with intratympanic methylprednisolone versus dexamethasone at baseline, 1 week, 1 month and 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size   Total Sample Size="46"
Sample Size from India="46" 
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   N/A 
Date of First Enrollment (India)   15/04/2026 
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  

 

This randomized controlled trial aims to compare the efficacy of intratympanic methylprednisolone and dexamethasone in the treatment of sudden sensorineural hearing loss SSNHL, an otological emergency with variable prognosis and no clear consensus on optimal steroid therapy. A total of 46 patients aged 18 to 65 years diagnosed with SSNHL greater than or equal to 30 dB hearing loss over at least three consecutive frequencies will be enrolled and randomized into two groups using permuted block randomization.

Group 1 will receive intratympanic methylprednisolone 40 mg perml, and Group 2 will receive intratympanic dexamethasone 4 mg per ml, administered daily for five consecutive days under endoscopic or microscopic guidance. The primary outcome will be improvement in hearing assessed by Pure Tone Audiometry . Secondary outcomes include speech discrimination score, speech reception threshold, patient-reported outcomes, and adverse effects.

Participants will be followed up at 1 week, 2 weeks, and 1 month post-treatment. Hearing recovery will be categorized using Siegel’s criteria. Data will be analyzed using appropriate statistical tests. Ethical approval and informed consent will be obtained prior to study initiation.

 

 
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