| CTRI Number |
CTRI/2026/03/106212 [Registered on: 13/03/2026] Trial Registered Prospectively |
| Last Modified On: |
12/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Evaluation of function of Eustachian Tube (Connecting nose and ear) In Patients Suffering From Nasal Allergies Before And After Treatment In Tertiary Care Hospitals |
|
Scientific Title of Study
|
Evaluation Of Eustachian Tube Function In Patients With Allergic Rhinitis In Tertiary Care Hospitals |
| 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 DIVYA SUBRAMANIAN |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
KASTURBA MEDICAL COLLAGE MANGALORE |
| Address |
DEPARTMENT OF OTORHINOLARYNGOLOGY- HEAD AND NECK
KASTURBA MEDICAL COLLEGE MANGALORE, MANIPAL ACADEMY OF HIGHER EDUCATION, MANIPAL, INDIA
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
8447921848 |
| Fax |
|
| Email |
divya.kmcmlr2024@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
DR DEVIPRASAD D |
| Designation |
PROFESSOR AND HEAD |
| Affiliation |
KASTURBA MEDICAL COLLAGE MANGALORE |
| Address |
DEPARTMENT OF OTORHINOLARYNGOLOGY- HEAD AND NECK
KASTURBA MEDICAL COLLEGE MANGALORE, MANIPAL ACADEMY OF HIGHER EDUCATION, MANIPAL, INDIA
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
7892289410 |
| Fax |
|
| Email |
deviprasad.d@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
DR DIVYA SUBRAMANIAN |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
KASTURBA MEDICAL COLLAGE MANGALORE |
| Address |
DEPARTMENT OF OTORHINOLARYNGOLOGY- HEAD AND NECK
KASTURBA MEDICAL COLLEGE MANGALORE, MANIPAL ACADEMY OF HIGHER EDUCATION, MANIPAL, INDIA
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
8447921848 |
| Fax |
|
| Email |
divya.kmcmlr2024@learner.manipal.edu |
|
|
Source of Monetary or Material Support
|
| ICMR DHR GRANT FOR POST GRADUATE STUDENTS, INDIAN COUNCIL OF MEDICAL RESEARCH
MINISTRY OF HEALTH AND FAMILY WELFARE |
|
|
Primary Sponsor
|
| Name |
MANIPAL ACADEMY OF HIGHER EDUCATION |
| Address |
203, LIGHT HOUSE HILL ROAD
HAMPANKATTA, MANGALURU
KARNATAKA 575001 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR SHIVAPRAKASH DS |
GOVERNMENT WENLOCK HOSPITAL |
HAMPANKATTA MANGALORE
575001
Dakshina Kannada
KARNATAKA |
8217662885
dsdkannada1@gmail.com |
| DR CHAKRAPANI M |
KASTURBA MEDICAL COLLEGE HOSPITAL, ATTAVAR |
NANDIGUDDA RD
ATTAVAR
MANGALORE
KARNATAKA 575001
Dakshina Kannada
KARNATAKA |
08242422271
ms.kmchat@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE KASTURBA MEDICAL COLLEGE MANGALORE |
Approved |
| INSTITUTIONAL ETHICS COMMITTEE KASTURBA MEDICAL COLLEGE MANGALORE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J309||Allergic rhinitis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients of greater than 18 years with symptoms of AR for more than 3 months
Minimum 7 days of medication free interval for AR patients |
|
| ExclusionCriteria |
| Details |
Cases with
acute upper respiratory infection
history of CRS
history of acute and chronic otitis media
history of head trauma or ear trauma
history of nasal, pharyngeal and/or ear surgeries
age of less than 18 years
not willing to undergo investigations
symptoms of AR for less than 3 months
who were on medications for AR in last 7 days |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the Eustachian tube (ET) function in Allergic Rhinitis (AR) patients using ETDQ-7 Questionnaire, Multi Component Tympanometry (MCT) and Multi Frequency Tympanometry (MFT). |
Evaluations shall be done at baseline and after 4 weeks of follow up |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the ET function in cases of AR during initial evaluation (pre-treatment) and after one month of treatment using ETDQ-7 questionnaire
To determine the Resonant Frequency (RF) of the middle ear in cases of AR during initial evaluation (pre-treatment) and after one month of treatment using MCT and MFT
To determine the Susceptance (B) and Conductance (G) tympanograms at baseline and after 1 month of treatment in cases of AR using MFT
To evaluate the relationship between AR and ET function using the ETDQ-7, RF values and B & G tympanograms |
Baseline evaluation of the IgE and PTA with MFT, MCT shall be done at initial time of presentation.
After a period of 4 weeks, the subjects shall be reassessed, data collected and correlations shall be assessed |
|
|
Target Sample Size
|
Total Sample Size="56"
Sample Size from India="56"
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)
|
01/04/2026 |
| 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="2"
Months="0"
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
|
This study aims to assess the correlation of eustachian tube function in patients of allergic rhinitis and whether there is any improvement in the same on treatment of allergic rhinitis. Subjects recruited for the trial shall undergo baseline evaluation using IgE levels and audiometric tests such as PTA, Impedance, MCT and MFT along with ETDQ7. Following this, a 1 month standard treatment of allergic rhinitis shall be given after which patients shall undergo repeat investigations to assess improvement in ET functions. Correlations, if found, can significantly improve the quality of life of patients with AR |