| CTRI Number |
CTRI/2025/07/091038 [Registered on: 16/07/2025] Trial Registered Prospectively |
| Last Modified On: |
14/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of budesonide (a steroid)-enhanced ringers lactate (regular solution) nasal wash versus ringers lactate nasal (regular solution) wash in patients with Chronic rhinosinusitis after endoscopic sinus surgery |
|
Scientific Title of Study
|
A comparative, open-label, randomized study of efficacy and tolerability of nasal irrigation with budesonide-enhanced ringer’s lactate versus ringer’s lactate alone in post functional endoscopic sinus surgery with chronic rhinosinusitis |
| 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 Charumathi P C |
| Designation |
Postgraduate resident, Department of Pharmacology |
| Affiliation |
KEMPEGOWDA INSTITUTE OF MEDICAL SCIENCES |
| Address |
PG room, Dept of pharmacology, 3rd floor, preclinical block, Kempegowda Institute of Medical Sciences, 30th Main Road, 2nd Stage, Banashankari, Bengaluru, Karnataka 560070
Bangalore
KARNATAKA
560070
India |
| Phone |
7339584784 |
| Fax |
|
| Email |
charumathipc2000@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Priyanka S |
| Designation |
Associate professor, Department of Pharmacology |
| Affiliation |
KEMPEGOWDA INSTITUTE OF MEDICAL SCIENCES |
| Address |
Associate professor room, Dept of pharmacology, 3rd floor, preclinical block, Kempegowda Institute of Medical Sciences, 30th Main Road, 2nd Stage, Banashankari, Bengaluru, Karnataka 560070
Bangalore
KARNATAKA
560070
India |
| Phone |
09844093100 |
| Fax |
|
| Email |
drpriyanka110@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Charumathi P C |
| Designation |
Postgraduate resident, Department of Pharmacology |
| Affiliation |
KEMPEGOWDA INSTITUTE OF MEDICAL SCIENCES |
| Address |
PG room, Dept of pharmacology, 3rd floor, preclinical block, Kempegowda Institute of Medical Sciences, 30th Main Road, 2nd Stage, Banashankari, Bengaluru, Karnataka 560070
Bangalore
KARNATAKA
560070
India |
| Phone |
7339584784 |
| Fax |
|
| Email |
charumathipc2000@gmail.com |
|
|
Source of Monetary or Material Support
|
| KIMS Hospital and Research Centre, Krishna Rajendra Rd, Parvathipuram, Vishweshwarapura, Shankarapura, Bengaluru, Karnataka, India 560002 |
|
|
Primary Sponsor
|
| Name |
Dr Charumathi P C |
| Address |
PG room, Dept of Pharmacology, 3rd floor, preclinical block, KIMS, Siddhana layout, Banashankari 2nd stage, Bengaluru, Karnataka 560085 |
| Type of Sponsor |
Other [Self] |
|
|
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 Charumathi P C |
KIMS Hospital |
PG room, dept of pharmacology, 3rd floor, preclinical block, Kempegowda Institute of Medical Sciences, 30th Main Road, 2nd Stage, Banashankari, Bengaluru, Karnataka 560070
Bangalore
KARNATAKA |
07339584784
charumathipc2000@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, KIMS, Bengaluru |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J329||Chronic sinusitis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Budesonide enhanced Ringers lactate |
Budesonide enhanced Ringer’s lactate solution: Each budesonide respule contains 0.5mg/2mL. 1 mg budesonide (2 respules) in 500ml Ringer’s lactate per day. 40mL of the prepared solution is used per session twice daily (morning and evening) for 6 weeks, 20mL for each side of the nose per session.
A 20cc sterile syringe is used to deliver the irrigation solution into each nostril with controlled pressure.
Two budesonide (0.5mg/2mL each) respules are mixed in 500mL of Ringer’s Lactate. 20mL of this solution is instilled into each nostril per session using the syringe, twice daily. The patient should lean forward, tilt the head sideways, and allow the solution to exit through the opposite nostril.
|
| Comparator Agent |
Ringers Lactate |
Ringer’s lactate solution (0.9%). 40mL of Ringer’s Lactate per session twice daily (morning and evening) for 6 weeks, 20mL for each side of the nose per session.
A 20cc sterile syringe is used to deliver the irrigation solution into each nostril with controlled pressure.
The patient should lean forward, tilt the head sideways, and allow the solution to exit through the opposite nostril.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Subjects aged from 18 to 65 years, irrespective of gender and willing to give written informed consent are eligible.
2.Subjects with unilateral or bilateral chronic rhinosinusitis with or without nasal polyp (diagnosed according to the criteria outlined in the EPOS 2020 guidelines) who have been documented with failed medical treatment and are planned for FESS for the treatment of CRS.
|
|
| ExclusionCriteria |
| Details |
1. Subjects with history of known allergies or hypersensitivity to budesonide or any component of Ringer’s lactate irrigation solution.
2. Subjects diagnosed with cystic fibrosis, immotile cilia syndrome and sinonasal tumours or obstructive lesions.
3. Subjects using other intranasal medications or therapies (such as antihistamines or decongestants) during the study period will be excluded.
4. Subjects with other ENT conditions that could confound results, such as active middle ear disease, fungal sinusitis, cholesteatoma, or ossicular discontinuity.
5. Subjects who have undergone recent nasal surgeries or who have experienced nasal trauma in the past three months that could affect study results.
6. Subjects with hyperkalaemia, renal or hepatic impairment.
7. Subjects who are pregnant or lactating mothers.
8. Subjects who are immunocompromised (e.g., HIV/AIDS, those on chemotherapy or immunosuppressants).
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
SNOT-22 Score: Reduction in symptom severity measured by the SNOT
22 questionnaire at baseline (pre-operatively), 3rd week, and 6th week post
intervention.
2. LKE Score: Improvement in nasal endoscopy scores (assessing oedema,
discharge, polyps, and scarring) at baseline (pre-operatively), 3rd week and
6th week post-intervention.
|
baseline (pre-operatively), 3rd week and
6th week post-intervention. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
HRQL - measured via RSDI questionnaire at baseline, 6th week.
2. Tolerability parameter: Adverse events (e.g., nasal irritation, nasal
dryness, burning or stinging sensation, epistaxis, secondary infections,
allergic or hypersensitivity reactions) in both the study groups during the
study period will be documented & assessed for tolerability. |
baseline, 6th week.
|
|
|
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
01/08/2025 |
| 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="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
|
1. It is a prospective, comparative, open-label, randomized control study that will be conducted in the Otorhinolaryngology department of KIMS hospital, Bangalore for a period of 1.5 years. 2. Subjects will be recruited based on inclusion and exclusion criteria after getting approval from Institutional Ethics Committee (IEC). 3. The written informed consent will be obtained from all the study subjects after being satisfactorily informed about the study’s methodology. 4. Demographic data and relevant medical history will be obtained from all the study subjects. 5. Relevant examinations and baseline investigations are done pre-operatively (visit 0). SNOT-22 (Sino-Nasal Outcome Test–22) questionnaire will be administered to the study subjects by the investigator through a direct interview, during which the study subjects will be asked each question, and their responses will be recorded accordingly. Lund Kennedy Endoscopic (LKE) score will be assessed by the investigator. The HRQL based on RSDI (Rhino Sinusitis Disability Index) will also be documented. 6. Based on simple randomization in a 1:1 allocation, subjects (n = 100) will be split into two groups (50 in each) after the FESS operation: Interventions: GROUP A (n=50): Ringer’s lactate nasal irrigation enhanced with budesonide. Budesonide solution (Budesonide respules used for irrigation): 0.5mg/2mL respules. 1 mg budesonide (2 respules) in 500ml Ringer’s lactate per day. 40mL of the prepared solution is used per session twice daily (morning and evening) for 6 weeks, 20mL for each side of the nose per session. GROUP B (n=50): Ringer’s lactate solution for nasal irrigation. 1. Sino-Nasal Outcome Test (SNOT-22) 2. Lund-Kennedy Endoscopic Score (LKE Score) 3. Rhinosinusitis Disability Index (RSDI) Ringer’s lactate solution (0.9%). 40mL of Ringer’s Lactate per session twice daily (morning and evening) for 6 weeks, 20mL for each side of the nose per session. DEVICE: A 20cc sterile syringe is used to deliver the irrigation solution into each nostril with controlled pressure. ADMINISTRATION: Two budesonide (0.5mg/2mL each) respules are mixed in 500mL of Ringer’s Lactate. • 20mL of this solution is instilled into each nostril per session using the syringe, twice daily. The patient should lean forward, tilt the head sideways, and allow the solution to exit through the opposite nostril. |