FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/10/075237 [Registered on: 14/10/2024] Trial Registered Prospectively
Last Modified On: 04/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparative study of 2 drugs i.e Dexamethasone versus Methylprednisolone when injected intratympanically for patients of sudden sensorineural hearing loss , in terms of improvement in hearing 
Scientific Title of Study   Intratympanic dexamethasone injection versus Intratympanic Methylprednisolone for treatment of sudden sensorineural hearing loss : A Randomised 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  Dr Kanika 
Designation  DNB resident 1st year 
Affiliation  Government Multi Specialty Hospital  
Address  Department of Otorhinolaryngology (ENT) Government Multi Specialty Hospital , Sector-16, Chandigarh

Chandigarh
CHANDIGARH
160016
India 
Phone  9478927422  
Fax    
Email  kanikagarg098@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Manwinder Singh 
Designation  SMO i/c Department of ENT (Guide) 
Affiliation  Government Multi Specialty Hospital  
Address  SMO and Head of Department Department of Otorhinolaryngology (ENT) Government Multi Specialty Hospital , Sector-16, Chandigarh

Chandigarh
CHANDIGARH
160016
India 
Phone  9872030224  
Fax    
Email  doctormanvinder@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Sandeep Bansal 
Designation  SMO (Co-guide) 
Affiliation  Government Multi Specialty Hospital  
Address  SMO Department of Otorhinolaryngology (ENT) Government Multi Specialty Hospital , Sector-16, Chandigarh

Chandigarh
CHANDIGARH
160016
India 
Phone  9814243179  
Fax    
Email  skb.aquarian@gmail.com  
 
Source of Monetary or Material Support  
Government Multi Specialty Hospital , Sector -16 , Chandigarh 
 
Primary Sponsor  
Name  Dr Kanika 
Address  Government Multi Specialty Hospital , Sector -16 , Chandigarh 
Type of Sponsor  Other [self] 
 
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 Kanika  Government Multi Specialty Hospital , Sector-16 , Chandigarh  Room no. 427 Department of ENT
Chandigarh
CHANDIGARH 		 9478927422

kanikagarg098@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee (GMSH, Chandigarh)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H912||Sudden idiopathic hearing loss,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Intratympanic Dexamethasone injection  0.4 ml inj dexamethasone (4mg/ml) on alternate days (3 doses) 
Intervention  Intratympanic Methylprednisolone injection  0.4 ml inj methylprednisolone (40mg/ml) on alternate days (3 doses) 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1.Individuals aged 18 years or older with sudden sensorineural hearing loss as determined
by history & confirmed by audiometry.
2.Patients presenting within 2 weeks of onset of hearing loss. 
 
ExclusionCriteria 
Details  1.Patients who do not consent to participate in the study.
2.Patients with middle ear tumours and diseases.
3.Patients with viral infections.
4.Patients with hearing loss of more than 2 weeks duration.
5.Patients who have previously been treated for the same complaint.
6.Patients on ototoxic medication.
7.Patients with traumatic middle ear conditions.
8.Patients with organic disorders such as Type 2 Diabetes Mellitus (T2DM), Chronic Renal Failure (CRF), tuberculosis, peptic ulcers, and glaucoma. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To assess the therapeutic effectiveness of a intratympanic dexamethasone as compared to
intratympanic methylprednisolone To evaluate the frequency specific improvement in both group of patients on steroid
therapies 		 To evaluate hearing by PTA at 2, 4 and 8 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate the side effects of both drugs in respective groups of patients.  To evaluate side effects  
 
Target Sample Size   Total Sample Size="42"
Sample Size from India="42" 
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 4 
Date of First Enrollment (India)   20/10/2024 
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="1"
Months="2"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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  

In this study, we will compare the therapeutic effectiveness of a intratympanic dexamethasone as compared to intratympanic methylprednisolone and the behavior of the different audiometric curves in response to both steroid therapies.

Patients presenting with sudden sensorineural hearing loss to the Department of ENT, Head and Neck Surgery at Government Multi Specialty Hospital, Chandigarh will be subjected to routine tests.

Patients will be randomly assigned into 2 groups based on their enrolment number. Even number patients will be in group I and odd number patient will be in group 2. Those in group I will be treated with 3 doses of 0.4 ml Intratympanic injections of Dexamethasone (4mg/ml); on alternate days and those in group 2 will receive 3 doses of 0.4 ml intratympanic methylprednisolone (40mg/ml). PTA will be repeated at 2 weeks, 4 weeks and 8 weeks from the first dose.

In the present study we will be comparing effectiveness of intratympanic dexamethasone and intratympanic methylprednisolone in the treatment of sudden sensorineural hearing loss as it creates a significant impact on the life of the patient.

 
Close