| CTRI Number |
CTRI/2024/01/061229 [Registered on: 08/01/2024] Trial Registered Prospectively |
| Last Modified On: |
04/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To compare the middle ear status in patients with allergic rhinitis and those without. |
|
Scientific Title of Study
|
Comparison of middle ear changes between patients with and without allergic rhinitis. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Manimaran Marimuthu |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medial College, Manipal University |
| Address |
Department of Otorhinolaryngology, 4th floor OPD block, Kasturba Medical College, Manipal, Udupi, Karnataka, India, 576104
Udupi
KARNATAKA
576104
India |
| Phone |
9345590453 |
| Fax |
|
| Email |
veechmaran@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rohit Singh |
| Designation |
Associate Professor |
| Affiliation |
Kasturba Medical College |
| Address |
Department of Otorhinolaryngology, 4th floor OPD block, Kasturba Medical College, Manipal, Udupi, Karnataka, India, 576104
Udupi
KARNATAKA
576104
India |
| Phone |
9900405817 |
| Fax |
|
| Email |
rohit.singh@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Manimaran Marimuthu |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medial College, Manipal University |
| Address |
Department of Otorhinolaryngology, 4th floor OPD block, Kasturba Medical College, Manipal, Udupi, Karnataka, India, 576104
Udupi
KARNATAKA
576104
India |
| Phone |
9345590453 |
| Fax |
|
| Email |
veechmaran@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College, Department of Otorhinolaryngology, 4th floor OPD block, Kasturba Medical College, Manipal, Udupi, Karnataka, India, 576104 |
|
|
Primary Sponsor
|
| Name |
Kasturba Medical College |
| Address |
Department of Otorhinolaryngology, 4th floor OPD block, Kasturba Medical College, Manipal, Udupi, Karnataka, India, 576104 |
| 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 Manimaran Marimuthu |
Kasturba Medical College Manipal |
Department of Otorhinolaryngology, 4th floor OPD block, Kasturba Medical College, Manipal, Udupi, Karnataka, India, 576104
Udupi
KARNATAKA |
9345590453
veechmaran@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Institutional Ethics Committee - 2 (Student Research) |
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 |
90.00 Year(s) |
| Gender |
Both |
| Details |
Patients of 18 to 90 years with clinical diagnosis of allergic rhinitis on the basis of signs and symptoms using the SFAR score
patients of 18 to 90 years without allergic rhinitis on the basis of signs and symptoms using the SFAR score |
|
| ExclusionCriteria |
| Details |
Patients with middle ear pathology
Patients with prior history of ear surgery
Patients with tympanic membrane perforation
Patients with discharging ear
Patients not willing to give consent to be part of the study |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Prevalence of middle ear pathology in patients with allergic rhinitis
|
1 - 2 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the middle ear status between patients with allergic rhinitis and without allergic rhinitis |
1-4 Days |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
24/01/2024 |
| 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 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 - NO
|
|
Brief Summary
|
Allergic rhinitis (AR) is a common condition affecting 20-30% of the population. This condition affects not only the nose but also the sinuses and ears in many ways. Many studies are there worldwide implicating AR as a cause of serous otitis media. But only few studies have actually studied the tympanic membrane (TM) changes observed in patients with allergic rhinitis. The aim of this study is to document the TM and middle ear changes observed in patients with AR and without ARAfter obtaining the regulatory approvals including CTRI registration, the outpatients seen or inpatients admitted under the Department of ENT, Kasturba Hospital, Manipal will be screened for possible inclusion into the study. This is a prospective and comparative study with 90 subjects recruited (45 cases and 45 controls) then a work-up will be carried out through a questionnaire(SFAR) from which the subjects who have a score of more than 7 will be considered as cases and those with a score of less than 7 will be considered controls. Once patients and healthy controls give their written consent to participate in the study a detailed history and clinical examination of the patients will be done along with a complete audiological work up including tympanometry studies will be performed, the results will be compiled and analyzed. |