| CTRI Number |
CTRI/2025/02/080682 [Registered on: 17/02/2025] Trial Registered Prospectively |
| Last Modified On: |
16/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of two differnt drugs in management of acute bronchial asthma |
|
Scientific Title of Study
|
Nebulized levosalbutamol versus combination of magnesium sulphate and levosalbutamol nebulization in acute bronchial asthma |
| 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 Asha B D |
| Designation |
Second year post graduate Pediatrics |
| Affiliation |
Shyam Shah medical college |
| Address |
Shyam Shah medical college.
Pediatrics
Rewa,PIN -486001
Madhya Pradesh
Rewa
MADHYA PRADESH
486001
India |
| Phone |
8495037069 |
| Fax |
|
| Email |
ashabc9632@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shabd Singh Yadav |
| Designation |
Professor,Department of Pediatrics |
| Affiliation |
Shyam Shah medical college |
| Address |
Department of pediatric,Shyam Shah medical college.Rewa PIN-486001,Madhya Pradesh
Rewa
MADHYA PRADESH
486001
India |
| Phone |
9827260904 |
| Fax |
|
| Email |
Sshabd@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shabd Singh Yadav |
| Designation |
Professor,Department of Pediatrics |
| Affiliation |
Shyam Shah medical college |
| Address |
Department of pediatric,Shyam Shah medical college.Rewa PIN-486001,Madhya Pradesh
Rewa
MADHYA PRADESH
486001
India |
| Phone |
9827260904 |
| Fax |
|
| Email |
Sshabd@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Shyam Shah medical college,Rewa 486001 |
|
|
Primary Sponsor
|
| Name |
Shyam Shah medical college |
| Address |
486001 Rewa, Madhya Pradesh India |
| Type of Sponsor |
Government 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 Asha B D |
Shyam Shah medical college,REWA |
Shyam Shah medical college
Pediatrics department
Rewa 486001 Madhya Pradesh
Rewa
MADHYA PRADESH |
8495037069
ashabc9632@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| S.S Medical College Rewa |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J459||Other and unspecified asthma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nebulisation in acute bronchial asthma
Intervention -Group B nebulised with magnesium sulphate and levosalbutamol
Comparator agent-Group A nebulised with levosalbutamol.
|
Group B is nebulised with Magnesium sulphate in the form of 2 doses of nebulised olution 10 gm% 20 min apart with 4 doses of nebulised levosalbutamol solution 0.5 gm percent 20 minutes apart levosalbutamol |
| Comparator Agent |
Nebulisation in acute bronchial asthma |
Group A is nebulised with levosalbutamol in the form of 4 doses of nebulised solution 0.5 gm% 20 min apart. |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
Patients newly diagnosed or known cases of bronchial asthma,aged 2-15 years are Nebulized bronchodilator which will be levosalbutamol in group (A) in the form of 4 doses of nebulized solution 0.5 gm% (each dose 1 ml containing 5 mg levosalbutamol) twenty minutes apart and magnesium sulphate in group (B) in the form of 2 doses of nebulized solution 10 gm% (each dose 1 ml containing 100 mg magnesium sulphate) twenty minutes apart with 4 doses of nebulized solution 0.5 gm percent (each dose 1ml containing 5 mg levosalbutamol) twenty minutes apart
Reassessment of the patients will be performed after 2 hours to detect improvement. |
|
| ExclusionCriteria |
| Details |
1.Fever
2.Smoker
3.COPD patients
4.Pneumonia
5.Cardiac,renal or hepatic insufficiency
6.Respiratory failure |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reassessment of vitals heart rate,respiratory rate,saturation,Glass Gow Coma scale and peak expiratory flow metre at baseline and after 2 hours. |
Reassessment of vitals heart rate,respiratory rate,saturation,Glass Gow Coma scale and peak expiratory flow metre at baseline and after 2 hours. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Duration of stay in intensive care unit.
Duration of hospital stay |
Duration of stay in intensive care unit
Duration of hospital stay |
|
|
Target Sample Size
|
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" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
27/02/2025 |
| 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)
|
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
|
Nebulized bronchodilator which will be levosalbutamol in group A in the form of 4 doses of nebulized solution 0.5g% 20 minutes apart and magnesium sulphate in group B in the form of 2 doses nebulized solution 10g% with 4 doses of nebulized levosalbutamol 20 minutes apart. Reassessment of the patients will be performed after 2 hours to detect improvement. |