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CTRI Number  CTRI/2025/08/092538 [Registered on: 06/08/2025] Trial Registered Prospectively
Last Modified On: 26/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study where we compare the new treatment protocol with the standard one used in the management of acute exacerbation of asthma. 
Scientific Title of Study   Comparison between nebulized magnesium sulphate with salbutamol and nebulized salbutamol alone as a first line management for acute exacerbation of asthma in pediatrics population- A Randomised control 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 Bhanupriya Sharma 
Designation  Junior resident 
Affiliation  IGMC shimla 
Address  Block B, 4th floor, pediatric emergency ward, department of pediatrics, IGMC shimla

Shimla
HIMACHAL PRADESH
171001
India 
Phone  8570875909  
Fax    
Email  shrmabhanupriya@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Rajinder singh 
Designation  Associate Professor  
Affiliation  IGMC shimla 
Address  Block A,2nd floor, room no 6, IGMC SHIMLA

Shimla
HIMACHAL PRADESH
171001
India 
Phone  08219160813  
Fax    
Email  dr438raj@gmail.com  
 
Details of Contact Person
Public Query  
Name  Bhanupriya Sharma 
Designation  Junior resident 
Affiliation  IGMC shimla 
Address  Bloc B, 4th floor, pediatric emergency ward, department of pediatrics, IGMC shimla

Shimla
HIMACHAL PRADESH
171001
India 
Phone  8570875909  
Fax    
Email  shrmabhanupriya@gmail.com  
 
Source of Monetary or Material Support  
Infrastructural support - B block, 4th floor, pediatric emergency ward, Igmc shimla, pincode - 171001. State - himachal pradesh Country - india  
 
Primary Sponsor  
Name  INDIRA GANDHI MEDICAL COLLEGE  
Address  IGMC,SHIMLA 
Type of Sponsor  Government 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 
Dr Bhanupriya Sharma  IGMC SHIMLA   B block, 4th floor, pediatric emergency ward, IGMC shimla
Shimla
HIMACHAL PRADESH 		 08570875909

shrmabhanupriya@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee, IGMC shimla  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J22||Unspecified acute lower respiratory infection,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nebulisation with magnesium sulphate   1 group will be nebulized with salbutamol alone @0.07 mg/kg 3 times for the first hour and other will be nebulized with salbutamol 0.07 mg/kg and magnesium sulfate 150 mg/dose. Subsequently improvement in PEFR and PRAM score will be compared. 
Comparator Agent  Nebulised salbutamol alone   We will nebulise the patient with salbutamol at 0.07 mg/kg alone as per standard guidelines of asthma treatment protocol  
 
Inclusion Criteria  
Age From  5.00 Year(s)
Age To  17.00 Year(s)
Gender  Both 
Details 
Children between the ages of 5-17 years of age diagnosed as acute exacerbation of asthma.
And have an initial pediatric respiratory assessment measure (PRAM) more than 4.
Or is a known case of childhood asthma or past history of similar episodes relieved with bronchodilator therapy or already on Controller therapy or family history of asthma/ atopy/ nebulisations or personal history of atopic dermatitis/ food allergy/ allergic rhinitis.
 
 
ExclusionCriteria 
Details   
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
The primary outcome is the difference in improvement of PEFR between the 2 groups  The primary outcome is the difference in PEFR at 0, 20, 60 min and 24 hrs 
 
Secondary Outcome  
Outcome  TimePoints 
Improvement in PRAM score at 0 min, 20 min, 60 min, 24 hrs
Requirement of iv magnesium sulphate.
Duration of hospital stay 		 0 min, 20 min, 60 min and 24 hrs 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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 2/ Phase 3 
Date of First Enrollment (India)   17/08/2025 
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="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. 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

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [shrmabhanupriya@gmail.com].

  6. For how long will this data be available start date provided 21-06-2025 and end date provided 21-06-2026?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary
Modification(s)  		 In this study we will enroll all the patients of asthma presenting to emergency with acute exacerbation, and along with nebulised salbutamol, we will give nebulized magnesium sulfate during the initial nebulization treatment to the case group. We will subsequently record the improvement in PEFR and PRAM score in case and control group at different time intervals. If proven effective, this approach would improve emergency care protocols and provide better management of asthma exacerbation. 
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