FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/10/096708 [Registered on: 31/10/2025] Trial Registered Prospectively
Last Modified On: 30/10/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To compare which is more useful in treatment of acute bronchiolitis with N-Acetyl Cysteine vs 3% NaCl 
Scientific Title of Study   Effectiveness of N-Acetyl Cysteine vs 3% NaCl nebulisation in children with acute bronchiolitis aged 6 months to 2 years: A randomized controlled trial 
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 Madhan kumar  
Designation  Paediatrics postgraduate  
Affiliation  Aarupadai veedu medical college and hospital  
Address  A block ground floor Department of paediatrics Aarupadai veedu medical college and hospital kirumambakkam pondicherry

Pondicherry
PONDICHERRY
607402
India 
Phone  8524805538  
Fax    
Email  madhanrsk@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Chandru Bhaskar  
Designation  Professor  
Affiliation  Aarupadai veedu medical college and hospital  
Address  A block ground floor Department of paediatrics Aarupadai veedu medical college and hospital kirumambakkam pondicherry

Pondicherry
PONDICHERRY
607402
India 
Phone  9791783036  
Fax    
Email  chandru14885@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Thiyagaraajan  
Designation  Assistant professor  
Affiliation  Aarupadai veedu medical college and hospital  
Address  A block ground floor Department of paediatrics Aarupadai veedu medical college and hospital kirumambakkam pondicherry

Pondicherry
PONDICHERRY
607402
India 
Phone  9789666607  
Fax    
Email  drthiyagaraajan@gmail.com  
 
Source of Monetary or Material Support  
Aarupadai veedu medical college and hospital kirumambakkam pondicherry 636402 
 
Primary Sponsor  
Name  Aarupadai veedu medical college and hospital  
Address  Aarupadai veedu medical college and hospital Kirumampakkam Pondicherry cuddalore highway Pondicherry  
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
nil  nil 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
madhan kumar   aarupadai veedu medical college and hospital   room no 4 c block department of paediatrics aarupadai veedu medical college and hospital kirumambakkam pondicherry
Pondicherry
PONDICHERRY 		 8524805538

madhanrsk@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AVMC Institutional human ethics committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J219||Acute bronchiolitis, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  3% NaCl   3% NACL nebulisation 3 ml is used in the form of nebulization atleast 4 times a day for 5 days  
Intervention  N-acetyl cysteine   N-acetyl cysteine of dose 20mg is used in the form of nebulization 3 times a day then reduce the frequency of nebulization based on the improvement of the symptoms for 5 days 
 
Inclusion Criteria  
Age From  6.00 Month(s)
Age To  24.00 Month(s)
Gender  Both 
Details  First episode of respiratory distress associated with wheezing
Clinical severity score more than 3
No evidence of bacterial infection  
 
ExclusionCriteria 
Details  Cardiac diseases such as congenital heart disease
Preterm birth or history of mechanical ventilation in neonatal period
History of pneumonia  
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To evaluate the mean duration of hospital stay and change in clinical severity score parameters (respiratory rate ,o2 saturation,wheezing,retraction,general condition )  Assess pre treatment severity before 1st nebulization
Detect early response after 1st dose(after 6 hours of 1st dose),Evaluate ongoing improvement(on day 2,3,4) and final clinal outcome based on reduction of clinical severity score (on day 5)
 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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 3 
Date of First Enrollment (India)   11/11/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  11/11/2025 
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   3% NACL nebulisation is a hypertonic saline inducing an osmotic flow of water into the mucus layer thus increasing mucociliary clearance ,reducing airway edema.

N-acetylcysteine(NAC) nebulisation is an antioxidant that cleaves disulphide bonds by converting them to 2 sulphuryl groups.Thus action results in breakup of mucoprotein in lung mucus.
NAC has been used in treatment studies like in cystic fibrosis, chronic bronchitis,idiopathic pulmonary fibrosis and critically ill states

Need for the study: A few studies show that N-acetyl cysteine can be used in treatment of acute bronchiolitis by decreasing the clinical severity and reduce hospitalisationas compared to 3% NaCl.
 
Close