| CTRI Number |
CTRI/2025/04/085843 [Registered on: 28/04/2025] Trial Registered Prospectively |
| Last Modified On: |
24/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Intratympanic Dexamethasone efficacy in sudden SNHL Versus Oral Deflazacort in Sudden Sensorineural Hearing Loss |
|
Scientific Title of Study
|
Efficacy of Intratympanic Dexamethasone and Oral Deflazacort in Sudden Sensorineural Hearing Loss- A Randomized Single Blind 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 |
LIPSY |
| Designation |
PG RESIDENT |
| Affiliation |
KALINGA INSTITUTE OF MEDICAL SCIENCES, BHUBANESWAR, ODISHA |
| Address |
Kushabhadra campus(KIIT Campus-5), ENT DEPARTMENT, ROOM NUMBER 29, Patia, Bhubaneswar-751024, Odisha, India
Kushabhadra campus(KIIT Campus-5), ENT DEPARTMENT, ROOM NUMBER 29, Patia, Bhubaneswar-751024, Odisha, India
Khordha
ORISSA
751024
India |
| Phone |
7814930222 |
| Fax |
|
| Email |
dr.lipsygarg@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Manas Ranjan Rout |
| Designation |
Professor |
| Affiliation |
KALINGA INSTITUTE OF MEDICAL SCIENCES, BHUBANESWAR, ODISHA |
| Address |
Bank colony, Ranipatna, Balasore (Odisha), ENT DEPARTMENT KIMS, ROOM NUMBER 30
Bank colony, Ranipatna, Balasore (Odisha), ENT DEPARTMENT KIMS, ROOM NUMBER 30
Baleshwar
ORISSA
756001
India |
| Phone |
9701476440 |
| Fax |
|
| Email |
drmanas.1976@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
LIPSY |
| Designation |
PG RESIDENT |
| Affiliation |
KALINGA INSTITUTE OF MEDICAL SCIENCES, BHUBANESWAR, ODISHA |
| Address |
Kushabhadra campus(KIIT Campus-5), ENT DEPARTMENT KIMS, ROOM NUMBER 29, Patia, Bhubaneswar-751024, Odisha, India
Kushabhadra campus(KIIT Campus-5), ENT DEPARTMENT KIMS, ROOM NUMBER 29, Patia, Bhubaneswar-751024, Odisha, India
Khordha
ORISSA
751024
India |
| Phone |
7814930222 |
| Fax |
|
| Email |
dr.lipsygarg@gmail.com |
|
|
Source of Monetary or Material Support
|
| KALINGA INSTITUTE OF MEDICAL SCIENCES, BBSR, ORISSA |
|
|
Primary Sponsor
|
| Name |
DR LIPSY |
| Address |
Kushabhadra campus(KIIT Campus-5), Patia, Bhubaneswar-751024, Odisha, India |
| Type of Sponsor |
Other [Dr Lipsy] |
|
|
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 LIPSY |
Kalinga Institute of Medical Sciences |
Kushabhadra campus(KIIT Campus-5), ENT Department, Patia, Bhubaneswar-751024, Odisha, India
Khordha
ORISSA |
07814930222
dr.lipsygarg@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, KALINGA INSTITUTE OF MEDICAL SCIENCES (KIMS), KIIT DEEMED TO BE UNIVERSITY, BHUBANESWAR-751024 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H839||Unspecified disease of inner ear, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
INTRATYMPANIC DEXAMETHASONE (Randomized controlled trial) |
GROUP-A
Patients receiving intratympanic dexamethasone (0.5 ml 0r 2mg/ml - 3 doses, intratympanic route, 21 days))
|
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
| Intervention |
ORAL DEFLAZACORT (Randomized controlled trial) |
GROUP-B Patients receiving oral deflazacort (1mg/kg/day - 21 days, oral, 21 days) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients diagnosed with sudden SNHL for the first time (duration less than or equal to 7 days).
2. Patients with age group 18-65 years. |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the improvement of hearing by intratympanic dexamethasone versus oral deflazacort in sudden sensorineural hearing loss (SSNHL). |
1 week & 3 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the tolerability & side effects of intratympanic dexamethasone & oral deflazacort in patients under treatment for sudden sensorineural hearing loss.
|
1 week & 3 weeks |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
10/05/2025 |
| 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="2"
Months="0"
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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Data are available indefinitely at (Link to be included dr.lipsygarg@gmail.com).
- For how long will this data be available start date provided 03-03-2024 and end date provided 03-02-2026?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
There is a
need to find the comparison between the intratympanic dexamethasone and oral
deflazacort in the treatment of sudden sensorineural hearing loss because
sudden sensorineural hearing loss (SNHL) is a emergency condition.
•Not many
studies are available regarding the improvement in hearing loss after giving
oral corticosteroids.
•Hence,
this study is planned to assess the improvement in hearing loss and side
effects after giving intratympanic dexamethasone and oral deflazacort. |