| CTRI Number |
CTRI/2025/10/095816 [Registered on: 09/10/2025] Trial Registered Prospectively |
| Last Modified On: |
08/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
This study done to check how much quality of life improved after medical treatment and after surgical treatment . And then compare both the results with the help of sino nasal test score . |
|
Scientific Title of Study
|
A comparative study of the quality of life assessment with Sinonasal outcome test in patients of allergic rhinitis undergoing conservation versus surgical management at tertiary care center kannauj. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shreya Sharma |
| Designation |
Junior resident 1 |
| Affiliation |
Government Medical College kannauj |
| Address |
ent department, kannauj,room number 123
Kannauj
UTTAR PRADESH
209732
India |
| Phone |
6397961977 |
| Fax |
|
| Email |
shreya1308sharma@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sandeep Kaushik |
| Designation |
Head of department |
| Affiliation |
Government medical College kannauj |
| Address |
ENT department, Kannauj,room number 123
Kannauj
UTTAR PRADESH
209732
India |
| Phone |
8400331166 |
| Fax |
|
| Email |
dockaushik31@gamil.com |
|
Details of Contact Person
Public Query
|
| Name |
Sandeep Kaushik |
| Designation |
Head of department |
| Affiliation |
Government medical College, kannauj |
| Address |
ENT department, Kannauj,room number 123
Kannauj
UTTAR PRADESH
209732
India |
| Phone |
8400331166 |
| Fax |
|
| Email |
dockaushik31@gamil.com |
|
|
Source of Monetary or Material Support
|
| Dr.bimraoramji ambedkar Government medical College kannauj Uttar Pradesh, india 209732 |
|
|
Primary Sponsor
|
| Name |
Shreya sharma |
| Address |
Dr.BRRA Government medical College,kannauj, uttar pradesh India,209732 |
| 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 |
| Shreya Sharma |
Dr.bimraoramji ambedkar Government medical College Kannauj , uttar pradesh India |
ENT department,kannauj,room number 123
Kannauj
UTTAR PRADESH |
6397961977
shreya1308sharma@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical commitee government medical College kannauj Uttar Pradesh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Diagnostic nasal endoscopy |
Ones in 2 weeks for 3 months |
| Comparator Agent |
Diagnostic nasal endoscopy in allergic rhinitis |
Ones in 2 weeks for 3 month |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Clinically diagnosed case of allergic rhinitis at 18-60 years.
Patients who had not taken anti allergic medication for more then 6 weeks.
Patient with moderate to severe symptoms.
Patients who give consent. |
|
| ExclusionCriteria |
| Details |
Patient with sinonasal tumor .
History of any nasal surgery.
Patients with mild symptoms.
Patients with comorbidity like hypertension, diabetes.
Patients who loss to follow up. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The value OF SNOT-22 questionnaire in assessing the burden of allergic rhinitis evaluating both medical and surgical interventions. |
6 weeks to 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
08/11/2025 |
| 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="0"
Months="11"
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 is a immunoglobulin IGE mediated response triggered by exposure to indoor and outdoor allergens and pollens . Symptoms include nasal congestion sneezing runny nose , itching ,nose,eye,throat. The randomized control trail study done at government medical College kannauj . Universal sampling method is used to collect sample . |