| CTRI Number |
CTRI/2025/09/094679 [Registered on: 12/09/2025] Trial Registered Prospectively |
| Last Modified On: |
11/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
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Type of Study
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Diagnostic |
| Study Design |
Randomized, Parallel Group Trial |
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Public Title of Study
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A STUDY COMPARING TWO TYPES OF NASAL RINSES SALT WATER AND MINERALIZED SALT WATER FOR PEOPLE WITH CHRONIC SINUS DISEASE AFTER SINUS SURGERY TO SEE WHICH HELPS RECOVERY BETTER |
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Scientific Title of Study
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Comparative Efficacy of Buffered Hypertonic Saline and Ringer’s Lactate Nasal Irrigation in Postoperative Management of Chronic Rhinosinusitis: A Randomized Double-Blind Clinical Trial |
| Trial Acronym |
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Secondary IDs if Any
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| Secondary ID |
Identifier |
| NIL |
NIL |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
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| Name |
PATTEM MAHEETH |
| Designation |
Junior Resident |
| Affiliation |
Indira Gandhi medical College and hospital |
| Address |
Indira Gandhi medical College and hospital, Lakkar bazaar PIN 171001 Shimla Himachal pardesh
ENT HEAD AND NECK SURGERY DEPARTMENT DOCTORS DUTY ROOM,D block 3rd floor, Indira Gandhi Medical College and Hospital, Lakkar bazaar PIN 171001, Shimla Himachal Pradesh
Shimla
HIMACHAL PRADESH
171001
India |
| Phone |
8247453150 |
| Fax |
|
| Email |
Maheethpattem@outlook.com |
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Details of Contact Person
Scientific Query
|
| Name |
Professor Dr Ramesh Azad |
| Designation |
Head of the Department Otolaryngology head and neck surgery and Professor |
| Affiliation |
Indira Gandhi medical College and hospital |
| Address |
Department of Otolaryngology Office Indira Gandhi medical College and hospital, Lakkar bazaar PIN 171001 Shimla Himachal pardesh
Shimla
HIMACHAL PRADESH
171001
India |
| Phone |
9418491999 |
| Fax |
|
| Email |
drrameshazad@gmail.com |
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Details of Contact Person
Public Query
|
| Name |
Professor Dr Ramesh Azad |
| Designation |
Head of the Department Otolaryngology head and neck surgery and Professor |
| Affiliation |
Indira Gandhi medical College and hospital |
| Address |
Department of Otolaryngology Office Indira Gandhi medical College and hospital, Lakkar bazaar PIN 171001 Shimla Himachal pardesh
Shimla
HIMACHAL PRADESH
171001
India |
| Phone |
9418491999 |
| Fax |
|
| Email |
drrameshazad@gmail.com |
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Source of Monetary or Material Support
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Primary Sponsor
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| Name |
Indira Gandhi medical College and hospital Shimla |
| Address |
Indira Gandhi medical College and hospital Lakkar bazaar Shimla |
| Type of Sponsor |
Government medical college |
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Details of Secondary Sponsor
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Countries of Recruitment
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India |
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Sites of Study
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| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrPattem Maheeth |
Indira Gandhi Medical College and Hospital |
ENT HEAD AND NECK SURGERY OPD, 10TH FLOOR, ROOM NO 1016 MINOR OT AND PROCEDURE ROOM
Shimla
HIMACHAL PRADESH |
8247453150
Maheethpattem@outlook.com |
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Details of Ethics Committee
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| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Indira Gandhi Medical College |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
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| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J324||Chronic pansinusitis, |
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Intervention / Comparator Agent
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| Type |
Name |
Details |
| Comparator Agent |
Buffered Hypertonic Solution |
Buffered Hypertonic Solution
The buffered hypertonic solution is commercially available as the Nasoclear Nasal Wash Kit. The provided sachet contains two point three grams of sodium chloride in one hundred twenty milliliters of water. If this is scaled up to one liter, it corresponds to nineteen point two grams of sodium chloride per liter.
Since this concentration is much higher than nine grams per liter, it is not isotonic. The Nasoclear solution, with two point three grams of sodium chloride in one hundred twenty milliliters of water, gives a concentration of approximately one point nine two percent sodium chloride, classifying it as a hypertonic solution.
Role Of Sodium Bicarbonate (Seven Hundred Milligrams):
Sodium bicarbonate acts as a buffer to regulate the pH of the solution. This helps prevent irritation to the nasal mucosa, especially in hypertonic solutions. While it does not significantly affect the osmolarity, it contributes to the buffering effect of the solution. |
| Intervention |
Ringers Lactate Nasal Douching Solution |
Ringers Lactate Nasal Douching Solution:
The Ringers lactate nasal douching solution will serve as one of the two treatment arms in this randomized clinical trial. Ringers lactate is an isotonic solution commonly used in clinical settings for maintaining fluid and electrolyte balance. It contains sodium chloride, potassium chloride, calcium chloride, and sodium lactate, which collectively mimic the composition of the body’s extracellular fluid.
These properties make Ringers lactate potentially beneficial for promoting mucosal healing and reducing inflammation in postoperative nasal cavities.
Preparation:
The Ringers lactate solution will be sterile and prepared according to the manufacturer’s specifications. The solution will be dispensed in pre-measured containers suitable for nasal irrigation to ensure standardization and ease of use.
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Inclusion Criteria
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| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion Criteria:
1. Age And Gender:
Adults aged between eighteen to sixty-five years, regardless of gender.
2. Diagnosis Of Chronic Rhinosinusitis (CRS):
Diagnosed with Chronic Rhinosinusitis based on the European Position Paper on Rhinosinusitis and Nasal Polyps (EPOS Two Thousand Twenty) criteria, characterized by the following:
Symptom Duration:
Presence of symptoms for a minimum of twelve weeks.
Symptoms:
Presence of two or more of the following symptoms, one of which must be either nasal blockage, nasal obstruction, nasal congestion, or nasal discharge (either anterior or posterior nasal drip):
Mucopurulent drainage (anterior or posterior)
Nasal obstruction or congestion
Facial pain, pressure, or fullness
Decreased or loss of sense of smell
Objective Confirmation:
Symptomatology must be confirmed by either:
Endoscopic Signs: Presence of nasal polyps, mucopurulent discharge from the middle meatus, or mucosal edema or obstruction in the middle meatus.
CT Imaging: Evidence of mucosal alterations in the osteomeatal complex and or sinuses.
3. Inflammatory Documentation:
Evidence of sinonasal inflammation must be documented by one or more of the following:
Purulent (non-clear) mucus or edema in the middle meatus or ethmoid region
Presence of nasal polyps in the nasal cavity or middle meatus
Radiographic imaging showing inflammation in the paranasal sinuses
4. Willingness To Participate:
Patients must be willing to provide informed consent and agree to adhere to all study protocols.
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| ExclusionCriteria |
| Details |
Exclusion Criteria:
1. Pregnancy And Lactation:
Pregnant or breastfeeding women.
2. Severe Comorbid Conditions:
Presence of severe uncontrolled comorbidities such as:
Uncontrolled diabetes
Autoimmune diseases
Severe cardiovascular or respiratory diseases
3. Known Allergies:
Allergies to components of the nasal irrigation solutions, including Ringers lactate or buffered hypertonic saline.
4. Language Barrier:
Patients unable to speak or understand Hindi or English.
5. Mucociliary Disorders:
History of primary ciliary dyskinesia, cystic fibrosis, or other significant mucociliary dysfunction.
6. Dependence On Corticosteroids:
Patients requiring prolonged systemic corticosteroid therapy for comorbid conditions like asthma or chronic obstructive pulmonary disease.
7. Infections And Other Nasal Conditions:
History of cerebrospinal fluid leak
Current infection or history of:
Tuberculosis lung infection
Herpes infection of the eye
8. Surgical History And Disorders:
Previous nasal or sinus surgery within the last three months unrelated to the current chronic rhinosinusitis condition.
9. SNOT Twenty Two Score:
Patients with baseline SNOT Twenty Two scores below nine, as they may not achieve a minimally clinically significant improvement in the study.
10. Bleeding Disorders Or Allergy To Anesthetics:
Known bleeding disorders, use of blood thinners, or allergies to topical or injectable lidocaine.
11. Other Exclusions:
Patients unwilling or unable to comply with study protocols or follow-up visits. |
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Method of Generating Random Sequence
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Computer generated randomization |
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Method of Concealment
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Sequentially numbered, sealed, opaque envelopes |
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Blinding/Masking
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Participant and Investigator Blinded |
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Primary Outcome
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| Outcome |
TimePoints |
Primary Outcome:
Change in Sino Nasal Outcome Test Twenty Two (SNOT Twenty Two) Scores: The primary outcome is the change in SNOT Twenty Two scores from baseline to the end of the treatment period, which is six weeks. SNOT Twenty Two is a validated patient reported outcome measure assessing the severity of sinonasal symptoms and their impact on quality of life. Scores range from zero to one hundred ten, with higher scores indicating worse symptoms. Changes in SNOT Twenty Two will be compared between the Buffered Hypertonic Saline and Ringer’s Lactate groups.
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Baseline to the end of the treatment period, which is six weeks |
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Secondary Outcome
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| Outcome |
TimePoints |
Lund Kennedy’s Score via Nasal Endoscopy Findings
Patient comfort levels will be assessed using a Likert scale (1-10)
Adherence to the nasal irrigation regimen will be monitored through self-reported usage logs
collected during each follow-up visit |
Baseline to the end of the treatment period, which is six weeks |
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Target Sample Size
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Total Sample Size="70"
Sample Size from India="70"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
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Phase 2/ Phase 3 |
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Date of First Enrollment (India)
|
23/09/2025 |
| 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 |
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Estimated Duration of Trial
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Years="1"
Months="0"
Days="0" |
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Recruitment Status of Trial (Global)
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Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
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Publication Details
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N/A |
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Individual Participant Data (IPD) Sharing Statement
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Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [Maheethpattem@outlook.com].
- For how long will this data be available start date provided 07-09-2025 and end date provided 07-09-2035?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
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Brief Summary
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The primary aim of this study is to evaluate and compare the efficacy, safety, and patient compliance of Ringer’s lactate and buffered hypertonic saline nasal irrigation in the postoperative management of chronic rhinosinusitis (CRS) following endoscopic sinus surgery (ESS). The study seeks to determine whether Ringer’s lactate nasal irrigation provides comparable or superior symptom relief, promotes better mucosal healing (as assessed by Lund Kennedy score), and minimizes side effects, offering a safer and more tolerable alternative for long-term use compared to buffered hypertonic saline.
The study is designed to test the following hypotheses: H1 (Primary Hypothesis): Patients using Ringer’s lactate nasal irrigation will experience greater improvements (reduction in symptom burden) in Sino-Nasal Outcome Test-22 (SNOT-22) scores compared to those using buffered hypertonic saline solutions over the 6-week treatment period relative to baseline assessments in postsurgical CRS patients. H2 (Secondary Hypothesis): Ringer’s lactate nasal irrigation will result in greater reductions in Lund-Kennedy scores (improvement in mucosal healing, reduced inflammation, and polyp recurrence) compared to buffered hypertonic saline solutions over the 6-week treatment period relative to baseline assessments in post-surgical CRS patients.
Purpose of Hypothesis Testing By evaluating these hypotheses, this study aims to provide high-quality evidence on the efficacy, tolerability, and compliance of Ringer’s lactate nasal irrigation as a potential alternative to buffered hypertonic saline in post-surgical CRS management. The results will contribute to a comparative analysis of symptom relief, mucosal recovery, and patient adherence. Findings from this trial may inform clinical guidelines by determining whether Ringer’s lactate offers superior or equivalent benefits to hypertonic saline in enhancing post-ESS outcomes, potentially optimizing long-term CRS management strategies and improving patient quality of life.
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