| CTRI Number |
CTRI/2025/07/090788 [Registered on: 11/07/2025] Trial Registered Prospectively |
| Last Modified On: |
11/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Observational Study on Allergic rhinitis in hospital setting |
|
Scientific Title of Study
|
Clinical observational study of allergic rhinitis in a tertiary care hospital |
| 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 Anuja Kulkarni |
| Designation |
Sr DMO SG Consultant |
| Affiliation |
Jagjivan Ram Railway Hospital Mubai |
| Address |
Room No 5 Department of ENT Jagjivan Ram Railway Hospital maratha Mandir Marg Mumbai Central Mumbai 400008
India
Room No 5 Department of ENT Jagjivan Ram Railway Hospital maratha Mandir Marg Mumbai Central Mumbai 400008
India
Mumbai
MAHARASHTRA
400008
India |
| Phone |
9819464115 |
| Fax |
|
| Email |
dr.anujakulkarni@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Khush ardeshana |
| Designation |
PG Student |
| Affiliation |
Jagjivan Ram Railway Hospital Mubai |
| Address |
R No 5 Department of ENT Jagjivan Ram Railway Hospital maratha Mandir Marg Mumbai Central Mumbai 400008
India
R No 5 Department of ENT Jagjivan Ram Railway Hospital maratha Mandir Marg Mumbai Central Mumbai 400008
India
Mumbai
MAHARASHTRA
400008
India |
| Phone |
9819464115 |
| Fax |
|
| Email |
pbsjrh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anuja Kulkarni |
| Designation |
Sr DMO SG Consultant |
| Affiliation |
Jagjivan Ram Railway Hospital Mubai |
| Address |
Room No 5 Department of ENT Jagjivan Ram Railway Hospital maratha Mandir Marg Mumbai Central Mumbai 400008
India
Room No 5 Department of ENT Jagjivan Ram Railway Hospital maratha Mandir Marg Mumbai Central Mumbai 400008
India
Mumbai
MAHARASHTRA
400008
India |
| Phone |
9819464115 |
| Fax |
|
| Email |
dr.anujakulkarni@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jagjivan Ram Railway Hospital Maratha Mandir Mag Mumbai Central Mumbai 400008 |
|
|
Primary Sponsor
|
| Name |
Jagjivan Ram Railway Hospital |
| Address |
Jagjivan Ram Railway Hospital Maratha Mandir Mag Mumbai Central Mumbai 400008 |
| Type of Sponsor |
Other [Govt Hospital] |
|
|
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 Anuja Kulkarni |
Jagjivan Ram Railway Hospital |
Room No 5 Department of ENT Jagjivan Ram Railway Hospital Maratha Mandir Marg Mumbai Central Mumbai
Mumbai
MAHARASHTRA |
09819464115
dr.anujakulkarni@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC/JRH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J349||Unspecified disorder of nose and nasal sinuses, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
|
|
Inclusion Criteria
|
| Age From |
18.00 Day(s) |
| Age To |
99.00 Day(s) |
| Gender |
Both |
| Details |
All adult Patients aged MORE THAN 18years symptoms of allergic rhinitis presenting to ENT OPD |
|
| ExclusionCriteria |
| Details |
Children Less Than 12 Yrs Of Age
Pregnant Women
Those Who Are Mentally Challenged
Those Requiring Prolonged Ventilatory Support With Spo2 Less Than 88 % Room Air
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Resolution of Symptoms |
6 months 1 year and 2 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Disease specific morbidity |
at 2 years |
|
|
Target Sample Size
|
Total Sample Size="323"
Sample Size from India="323"
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)
|
25/07/2025 |
| 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="1"
Months="6"
Days="15" |
|
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
|
Oflate there is a surge of allergic rhinitis patients visiting ENT clinic. Commonly following known allergens are considered as predisposing risk factors for allergic rhinitis - fomites- dust, for (pet animal ,hair) , pollens , flowers , fragrance and food-viz citrus food , milk , etc . Although this factors are known , recently there is a surge in number of AR cases. However, the real cause is still not known. Besides ,there is no single study in the literature at present which can document the entire spectrum of all possible etiologial factor in one study . Hence , the present study has been proposed . This will further aid in the implementation of preventive measures. |