| CTRI Number |
CTRI/2026/02/105014 [Registered on: 27/02/2026] Trial Registered Prospectively |
| Last Modified On: |
21/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A comparative study between steroid vs normal saline nasal irrigation in post operative management of patients with sinusitis after sinus surgery |
|
Scientific Title of Study
|
A comparative study of efficacy of budesonide nasal irrigation vs normal saline nasal irrigation in postoperative management of patients with chronic rhinosinusitis after functional endoscopic sinus surgery |
| 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 Pavithra J |
| Designation |
PG Resident |
| Affiliation |
Command Hospital Airforce Bangalore |
| Address |
Command Hospital Airforce Bangalore, Old Airport Road, Agram Post, Bengaluru, Karnataka
Bangalore
KARNATAKA
560007
India |
| Phone |
9962464678 |
| Fax |
|
| Email |
pavithra.13june@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr (Surg Capt) Rahul Naga |
| Designation |
Senior Advisor & HOD |
| Affiliation |
Command Hospital Airforce Bangalore |
| Address |
Command Hospital Airforce Bangalore, Old Airport Road, Agram Post, Bengaluru, Karnataka
Bangalore
KARNATAKA
560007
India |
| Phone |
9962464678 |
| Fax |
|
| Email |
rahulnaga@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pavithra J |
| Designation |
PG Resident |
| Affiliation |
Command Hospital Airforce Bangalore |
| Address |
Command Hospital Airforce Bangalore, Old Airport Road, Agram Post, Bengaluru, Karnataka
Bangalore
KARNATAKA
560007
India |
| Phone |
9962464678 |
| Fax |
|
| Email |
pavithra.13june@gmail.com |
|
|
Source of Monetary or Material Support
|
| Command Hospital Airforce Bangalore, Karnataka |
|
|
Primary Sponsor
|
| Name |
Pavithra J |
| Address |
Command Hospital Airforce Bangalore, Old Airport Road, Agram Post, Bengaluru, Karnataka, Pin Code- 560007 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| PG CELL COMMAND HOSPITAL AIRFORCE BANGALORE |
COMMAND HOSPITAL AIRFORCE BANGALORE, CAMBRIDGE LAYOUT, JOGUPALAYA, KARNATAKA, PIN CODE- 560007 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Pavithra J |
Command Hospital Airforce Bangalore |
Department of ENT & Head-Neck Surgery, Old Airport Road, Agram Post, Bengaluru
Bangalore
KARNATAKA |
9962464678
pavithra.13june@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PG Cell Ethical Committee, Command Hospital Air |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J324||Chronic pansinusitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
All patients with Chronic Rhinosinusitis with Nasal Polyposis who undergo Functional Endoscopic Sinus Surgery |
|
| ExclusionCriteria |
| Details |
Revision Functional Endoscopic Sinus Surgery
Isolated Sinus Surgeries
Unwilling patients |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Sino Nasal Outcome Test (SNOT 22) Score & Lund Kennedy Endoscopic Score |
Pre- operative, Post-OP 1 week, Post-OP 1 month, Post-OP 3 months |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
04/03/2026 |
| 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 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
|
Chronic rhino-sinusitis (CRS) is an inflammatory disease of nose & PNS lasting 12 weeks or longer duration without resolution of symptoms. Patients diagnosed with CRS with nasal polyposis undergo Functional endoscopic sinus surgery in order to restore the ventilation & function of PNS. The post-operative period of FESS is crucial as normal & the diseased mucosa are removed by wound healing. The three fundamental agents in post endoscopic sinus surgery management are - Normal saline, nasal irrigation, topical steroid sprays. Normal saline following FESS is considered as first choice as NS is simple, harmless & cost effective & has more patient compliance. Steroids sprays have a definitive role in CRS; however the limitation of the conventionally available steroids is that they can’t be delivered properly & adequately to the entire nasal & sinus cavity. So,there comes the role of Budesonide nasal irrigation. Hence our study aims at comparing the efficacy of Budesonide nasal irrigation with Normal Saline nasal irrigation in terms of reducing Post operative inflammation, mucosal healing & symptom resolution in patients undergoing Functional Endoscopic Sinus Surgery for Chronic Rhino Sinusitis. Objective- To analyze the improvement in quality of life using patient reported outcome measures by Sino Nasal Outcome Test (SNOT 22) score & Lund-Kennedy Endoscopic score pre & post operatively. Toevaluate the overall post operative complication rates,including infections, adherence formation & polyp recurrence between the two groups. |