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CTRI Number  CTRI/2024/10/075401 [Registered on: 16/10/2024] Trial Registered Prospectively
Last Modified On: 10/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   comparison of effect of magnesium sulphate as an add-on therapy by different routes administration during acute exacerbation of chronic obstructive pulmonary disease 
Scientific Title of Study   Comparing the effect of intravenous and nebulised magnesium sulphate as an adjunctive therapy during acute exacerbation of chronic obstructive pulmonary disease, A randomized 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 Nidhi Anilkumar Bardiya 
Designation  Junior Resident 
Affiliation  Datta Meghe Institute of Higher Education and Research  
Address  Department of General Medicine, AVBRH building, Third floor, Sawangi, Meghe

Wardha
MAHARASHTRA
442001
India 
Phone  8888033435  
Fax    
Email  bardiyanidhi200398@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Shilpa Bawankule 
Designation  Professor 
Affiliation  Datta Meghe Institute of Higher Education and Research  
Address  Department of General Medicine, AVBRH building, Third floor, Sawangi, Meghe

Wardha
MAHARASHTRA
442001
India 
Phone  9673288822  
Fax    
Email  drshilpagaidhane@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Shilpa Bawankule 
Designation  Professor 
Affiliation  Datta Meghe Institute of Higher Education and Research  
Address  Department of General Medicine, AVBRH building, Third floor, Sawangi, Meghe


MAHARASHTRA
442001
India 
Phone  9673288822  
Fax    
Email  drshilpagaidhane@gmail.com  
 
Source of Monetary or Material Support  
Datta Meghe Institute of Higher Education and Research, Sawangi, Meghe, Wardha, India 442001 
 
Primary Sponsor  
Name  Datta Meghe Institute of Higher Education and Research  
Address  Sawangi, Meghe, Wardha, India 442001 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NA 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Nidhi Anilkumar Bardiya  Acharya Vinoba Bhave Rural Hospital  Department of General Medicine, AVBRH building, Third floor
Wardha
MAHARASHTRA 
8888033435

bardiyanidhi200398@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Datta Meghe Institute of Higher Education and Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J99||Respiratory disorders in diseasesclassified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  intravenous infusion of magnesium sulphate   intravenous infusion of 2 gm magnesium sulphate over 20 minutes as a single dose at presentation along with standard therapy during acute exacerbation of chronic obstructive pulmonary disease 
Comparator Agent  Nebulization with magnesium sulphate   Nebulization with 250 mg of magnesium sulphate over two minutes for three times at an interval of 30 minutes each which is at presentation, at 30 minutes and at 60 minutes from presentation along with standard therapy during acute exacerbation of chronic obstructive pulmonary disease 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  Clinically diagnosed cases of chronic obstructive pulmonary disease experiencing a moderate acute exacerbation according to the ROME proposal  
 
ExclusionCriteria 
Details  Patients requiring immediate endotracheal intubation on arriving at the emergency medicine department.
Patients with severe symptoms like breathlessness who are unable to blow into the PEFR device.
Patients with altered sensorium or reduced levels of consciousness unable to blow in the PEFR device.
Patients in shock with systolic blood pressure less than 100 mmhg
Patients with dyselectrolytemia contraindicating the use of magnesium sulphate like hyperkalaemia and hypocalcaemia
Patients with renal failure and heart block.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Assessment of improvement in the peak expiratory flow rate, blood gas analysis results and vital signs including heart rate, respiratory rate and oxygen saturation among participants in the study group.  At presentation and at 60 minutes after presentation. 
 
Secondary Outcome  
Outcome  TimePoints 
2. To monitor the symptomatic relief based on CAT score and assess the need for ICU admission, duration of hospital stay, need for invasive or non-invasive mechanical ventilation along with q SOFA score and CURB-65 score in these patients so as to determine the mortality and morbidity among the participants from the study group  at presentation and 60 minutes after presentation. 
 
Target Sample Size   Total Sample Size="112"
Sample Size from India="112" 
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)   01/11/2024 
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 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  

Background: Chronic obstructive pulmonary disease, characterised by chronic respiratory symptoms like dyspnoea, cough, sputum production and is often associated with episodes of acute exacerbations which may occur due to various triggers like bacterial or viral infections, exposure to pollutants like biomass fuels, crop residues, woods etc. various treatment modalities have been implicated in the management of these episodes of acute exacerbations of COPD. This randomized control trial aims to compare the effect of intravenous and nebulised magnesium sulphate as an adjunctive therapy during acute exacerbation of chronic obstructive pulmonary disease in this sample population.

Methods: The study will be conducted in within Department of medicine, at AVBRH, a tertiary care teaching hospital placed within geographic region of Wardha District. Study is done when approved via institute moral committee (applied for).The participants with acute exacerbation of chronic obstructive pulmonary disease will be randomized using a computer generated random sequence into two groups, Group A  receiving intravenous injection of magnesium sulphate as a single dose on presentation to emergency department and Group B receiving nebulisation with magnesium sulphate three times at an interval of 30 minutes each time (i.e on presentation, at interval of 30 minutes and then at 60 minutes from the time of presentation, as an adjunctive along with standard treatment for acute exacerbations of COPD. Various investigations will be conducted at baseline and throughout the study period, including peak expiratory flow rate (PEFR), arterial blood gas analysis (ABG), chest x ray, complete blood count and CURB-65, q SOFA and CAT scores will be assessed.

Expected Results: It is anticipated that intravenous magnesium sulphate as an adjunctive in treatment of acute exacerbation of chronic obstructive pulmonary disease will lead to improvement in bronchospasm and improve dyspnoea score, decrease the need for hospitalisation and / or duration of hospital stay among participants with acute exacerbation of COPD whereas nebulized magnesium sulphate may reduce the number of ICU admissions and improve dyspnoea. Positive effect of intravenous and nebulized magnesium sulphate as an adjunct in management of acute exacerbation of COPD and study outcomes are expected. Adherence to the intervention protocol and the safety and tolerability of intravenous and nebulized magnesium sulphate will also be evaluated.

 
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