| CTRI Number |
CTRI/2021/08/035830 [Registered on: 23/08/2021] Trial Registered Prospectively |
| Last Modified On: |
19/08/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Evaluation of Sensorineural hearing loss in unilateral mucosal type of Chronic Oitis Media |
|
Scientific Title of Study
|
Evaluation of Sensorineural hearing loss in unilateral mucosal type of Chronic Otitis Media |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr sanjay vikram soni |
| Designation |
Post Graduate resident |
| Affiliation |
Maulana Azad Medical College, New Delhi |
| Address |
ENT ward 6A
Sixth floor
New surgical block
Lok nayak hospital
delhi-110002
ENT ward 6A
Sixth floor
New surgical block
Lok nayak hospital
delhi-110002
Central
DELHI
110002
India |
| Phone |
9911347279 |
| Fax |
|
| Email |
sonisanjay560@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr JC Passey |
| Designation |
Director Professor |
| Affiliation |
Maulana Azad Medical College, New Delhi |
| Address |
ENT office
3rd floor,
BL Taneja block
lok nayak hospital
ENT office
3rd floor,
BL Taneja block
lok nayak hospital
Central
DELHI
110002
India |
| Phone |
9868108140 |
| Fax |
|
| Email |
drjcpassey@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr sanjay vikram soni |
| Designation |
Post Graduate resident |
| Affiliation |
Maulana Azad Medical College, New Delhi |
| Address |
ENT ward 6A
Sixth floor
New surgical block
Lok nayak hospital
delhi-110002
ENT ward 6A
Sixth floor
New surgical block
Lok nayak hospital
delhi-110002
Central
DELHI
110002
India |
| Phone |
9911347279 |
| Fax |
|
| Email |
sonisanjay560@gmail.com |
|
|
Source of Monetary or Material Support
|
| Lok Nayak Hospital, Jawaharlal Nehru marg, near delhi gate, new delhi- 110002 |
|
|
Primary Sponsor
|
| Name |
Lok Nayak Hospital new delhi |
| Address |
Maulana azad medical college and Lok Nayak Hospital
Bahadur shah zafar marg
New delhi-110002 |
| Type of Sponsor |
Government 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 Sanjay soni |
Lok Nayak Hospital |
Department of ENT and head & neck surgery,
Surgical block 6th floor
Central
DELHI |
9911347279
sonisanjay560@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, maulana azad medical college and associated lok nayak and GB pant hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H679||Otitis media in diseases classified elsewhere, unspecified ear, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Both male and female patients
2. Age- 5-50 years
3. History of unilateral ear discharge more than 6 months
|
|
| ExclusionCriteria |
| Details |
1. Bilateral chronic otitis media
2. History of head injury
3. History of Intracranial/ Extracranial complications
4. History of Previous Tympanomastoid surgery
5. History of use of systemic Ototoxic drugs
6. History of acoustic trauma/ chronic noise exposure
7. History of congenital/ syndromic hearing loss
8. Traumatic perforation
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to evaluate the sensorineural hearing loss component in mucosal type of chronic otitis media |
immediate |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
to study association of SNHL with the following risk factors-
duration of disease
activity f the disease |
3-6 months |
|
|
Target Sample Size
|
Total Sample Size="35"
Sample Size from India="35"
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)
|
23/08/2021 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Mucosal or safe type of chronic otitis media is only rarely associated with SNHL. Aim is to evaluate SNHL component in mucosal type of chronic otitis media. |