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CTRI Number  CTRI/2024/02/062858 [Registered on: 19/02/2024] Trial Registered Prospectively
Last Modified On: 25/01/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Difference between drugs in critically ill patient with enteral feed intolerance.  
Scientific Title of Study   Comparison of enteral erythromycin plus intravenous Metoclopramide versus entral erythromycin alone in critically ill patient with enteral feed intolerance 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Mohd Ruheel khan 
Designation  Junior resident in anesthesia department 
Affiliation  Era Medical college and hospital Lucknow 
Address  Era Medical college and hospital Lucknow Department of Anesthesiology Era Medical college and hospital sarfarazganj lucknow UP Lucknow UTTAR PRADESH 226003 India

Lucknow
UTTAR PRADESH
226003
India 
Phone  9611381565  
Fax    
Email  dr.mdruheelkhan@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Krishnapratap mall 
Designation  Professor and department of Anesthesiology ctvs unit 
Affiliation  Era Medical college and hospital Lucknow 
Address  Room no. 4 ,2 nd floor Era Medical college and hospital sarfarzganj Lucknow UTTAR PRADESH 226003 India

Lucknow
UTTAR PRADESH
226003
India 
Phone  9140283488  
Fax    
Email  Dr_mall_79@yahoo.com.in  
 
Details of Contact Person
Public Query  
Name  Dr Krishnapratap mall 
Designation  Professor ctvs unit department of Anaestheiology 
Affiliation  Era Medical college and hospital Lucknow 
Address  Room no. 4 ,2nd floor Era Medical college and hospital sarfarzganj Lucknow UTTAR PRADESH 226003 India

Lucknow
UTTAR PRADESH
226003
India 
Phone  9140283488  
Fax    
Email  Dr_mall_79@yahoo.com.in  
 
Source of Monetary or Material Support  
Not applicable 
 
Primary Sponsor  
Name  Eras Lucknow medical college and hospital 
Address  sarfarzganj lucknow UP 
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 
Dr Krishna pratap mall  ICU Eras Lucknow medical college and hospital  Eras Lucknow medical college and hospital LUCKNOW UP Lucknow UTTAR PRADESH
Lucknow
UTTAR PRADESH 		 9140283488

Dr_mall_79@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: R00-R99||Symptoms, signs and abnormal clinical and laboratory findings, not elsewhere classified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Erythromycin  Tablet erythromycin in dose of 250mg 6 hourly will be given to patients with gastric feed intolerance.  
Intervention  Erythromycin plus metacloperamide  Tablet erythromycin will be given in the dose of 250mg 6 hourly and injection metacloperamide in dose of 10mg 8 hourly to patients with gastric feed intolerance.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  Critically ill patients admitted in ICU who had enteral feed intolerence.

Patients of either sex

Patients of age group 18-75 year 
 
ExclusionCriteria 
Details  Patients with allergy to study drugs.
Treatment with any prokinetics drugs 24 h before participating in the study.
Hemodynamic instability or presence of cardarrhythmia or prolonged QT interval .
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
PRIMARY OBJECTIVES:
The rate of successful feeding at 48 hours after randomization.
 		 48 hours.  
 
Secondary Outcome  
Outcome  TimePoints 
Icu length of stay
Hospital length of stay
 		 Icu length of stay
Hospital length of stay 
 
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   N/A 
Date of First Enrollment (India)   25/02/2024 
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="2"
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.

  2. What additional supporting information will be shared?
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

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

  6. For how long will this data be available start date provided 01-01-2025 and end date provided 01-01-2030?
    Response (Others) - 

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   COMPARISON OF ENTERAL ERYHTROMYCIN PLUS INTRAVENOUS METOCLOPRAMIDE VERSUS ENTERAL ERYTHROMYCIN ALONE IN CRITICALLY ILL PATIENTS WITH ENTERAL FEED INTOLERANCE 
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