| CTRI Number |
CTRI/2025/12/099967 [Registered on: 30/12/2025] Trial Registered Prospectively |
| Last Modified On: |
29/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To compare Which is more useful in the treatment of acute bronchial asthma in childrens of 6-12 years when comparing between Magnesium Sulfate with salbutamol and salbutamol alone as the treatment |
|
Scientific Title of Study
|
Effectiveness and Safety Of Add On- Nebulized MgSO4 with salbutamol and Salbutamol Alone in Bronchial Asthma Management in Children of 6-12 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 |
Ramadoss gandhi karthikeyan |
| 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 |
7639154271 |
| Fax |
|
| Email |
dr.ramkarthik27@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 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 |
|
|
Source of Monetary or Material Support
|
| Aarupadai veedu medical college and hospital kirumambakkam pondicherry |
|
|
Primary Sponsor
|
| Name |
Aarupadai Veedu medical college and hospital |
| Address |
Aarupadai Veedu medical college and hospital kirumambakkam pondicherry cuddalore highway pondicherry 607402 |
| Type of Sponsor |
Private medical college |
|
|
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 Ramadoss Gandhi Karthikeyan |
Aarupadai veedu medical college and hospital |
Room no 4 c block department of paediatrics Aarupadai veedu medical college and hospital kirumambakkam pondicherry
Pondicherry
PONDICHERRY |
7639154271
dr.ramkarthik27@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AVMC Institutional human ethics committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J00-J99||Diseases of the respiratory system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Magnesium Sulfate with Salbutamol |
Magnesium Sulfate of dose 100mg with 0.5 ml of salbutamol is used in the form of nebulization for 4 times a day then the frequency of nebulization is reduced based on the improvement of the symptoms for 5 days |
| Comparator Agent |
Salbutamol |
Salbutamol nebulisation 2.5mg (0.5 ml) along with 2.5 ml of isotonic saline used in the form of nebulisation atleast 4 times a day for 5 days |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Children between 6 years and 12 years of age with acute bronchial asthma |
|
| ExclusionCriteria |
| Details |
Children below 6 years of age
Cardiac diseases such as congenital heart diseases
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 clinical outcome based on reduction of clinical severity score (on day 5) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="126"
Sample Size from India="126"
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)
|
09/01/2026 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
This study is a randomized parallel group active controlled trial conducted to evaluate the effectiveness and safety of add on nebulized magnesium sulfate in combination with salbutamol compared to salbutamol alone in the management of acute bronchial asthma in children aged 6 to 12 years. A total of 126 children diagnosed with acute bronchial asthma and requiring hospital admission will be enrolled and randomly allocated into two groups. The intervention group will receive nebulized magnesium sulfate 100 mg in combination with salbutamol 2.5 mg while the control group will receive nebulized salbutamol 2.5 mg with isotonic saline. Nebulization will be administered every 20 minutes for four doses using a jet nebulizer with oxygen. The primary outcome will be improvement in clinical severity score and peak expiratory flow rate. Secondary outcomes include duration of hospital stay and occurrence of adverse events. The study aims to generate evidence on the role of nebulized magnesium sulfate as an add on therapy in pediatric acute bronchial asthma. |