| CTRI Number |
CTRI/2024/10/075995 [Registered on: 28/10/2024] Trial Registered Prospectively |
| Last Modified On: |
19/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Effect of reflux disease on eustachian tube function |
|
Scientific Title of Study
|
Prevalence of chronic eustachian tube dysfunction in patients with Laryngopharyngeal Reflux disease/ Gastroesophageal reflux disease |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Archna Sachar |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of ENT-Head and Neck Surgery, Kasturba Hospital, Madhav Nagar, Manipal
Manipal Academy of higher education, Madhav Nagar, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
09704815846 |
| Fax |
|
| Email |
archnasachar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Balakrishnan R |
| Designation |
Professor & Unit Head - ENT 2 |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of ENT-Head and Neck Surgery, Kasturba Hospital, Madhav Nagar, Manipal
Manipal Academy of higher education, Madhav Nagar, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9845383714 |
| Fax |
|
| Email |
bala.ent@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Archna Sachar |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of ENT-Head and Neck Surgery, Kasturba Hospital, Madhav Nagar, Manipal
Manipal Academy of higher education, Madhav Nagar, Manipal
KARNATAKA
576104
India |
| Phone |
09704815846 |
| Fax |
|
| Email |
archnasachar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of ENT and Head and Neck surgery, Kasturba Hospital Manipal, Madhav Nagar, Manipal, Karnataka 576104, India |
|
|
Primary Sponsor
|
| Name |
Department of ENT and Head and neck surgery |
| Address |
ENT OPD, Kasturba Medical College, Madhav Nagar, Manipal 576104, Karnataka |
| Type of Sponsor |
Private 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 Archna Sachar |
Kasturba Hospital, Manipal |
Department of ENT, Kasturba Hospital, Manipal
Udupi
KARNATAKA |
09048158466
archnasachar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics committee- Student Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H68||Eustachian salpingitis and obstruction, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
No intervention is given to patients as it is an Observational study |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients diagnosed with GERD/LPRD without ear symptoms or with recent onset of ear symptoms suggestive of middle ear dysfunction, less than 6 months duration. |
|
| ExclusionCriteria |
| Details |
Pediatric population below 18 years
Patient with malignancies
Childhood otorrhoea
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Chronic eustachian tube dysfunction |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Pure tone audiometry
Nasal endoscopy |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="84"
Sample Size from India="84"
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)
|
01/11/2024 |
| 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="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
|
To aim of the study is to determine the association between reflux symptoms and the Eustachian tube (ET) function in adult patients as any significant association will help in the early diagnosis of Chronic Eustachian tube dysfunction among patients with LPRD or GERD. The outpatients from department of ENT, Medicine and Gastroenterology who have reflux disease will be determined by history and examination in the form of videolaryngoscopy will be evaluated for the presence of symptoms and signs of eustachian tube dysfunction using Questionnaire prepared from standard available literature and textbook will be recruited. They will then undergo PTA and tympanogram to diagnose the presence of eustachian tube dysfunction. Nasal endoscopy will be done to rule out any nasal pathologies. |