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CTRI Number  CTRI/2022/12/047818 [Registered on: 01/12/2022] Trial Registered Prospectively
Last Modified On: 07/11/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Other 
Public Title of Study
Modification(s)  		 Nutrition supplement for tube feeding assessed in hospitalized (ICU Stay) patients  
Scientific Title of Study   A prospective, open label, single arm, multicenter, interventional, study to assess the efficacy and tolerability of early enteral nutrition in hospitalized patients 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Rahul Rathod 
Designation  Head - Ideation and Clinical Research 
Affiliation  Dr Reddys Laboratories 
Address  Medical Affairs Department, Dr Reddys Laboratories Ltd, 7-1-27,Ameerpet, Hyderabad

Hyderabad
TELANGANA
500016
India 
Phone  04049048400  
Fax  04049048800  
Email  Rahul.Rathod@drreddys.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Rahul Rathod 
Designation  Head - Ideation and Clinical Research 
Affiliation  Dr Reddys Laboratories 
Address  Medical Affairs Department, Dr Reddys Laboratories Ltd, 7-1-27,Ameerpet, Hyderabad

Hyderabad
TELANGANA
500016
India 
Phone  04049048400  
Fax  04049048800  
Email  Rahul.Rathod@drreddys.com  
 
Details of Contact Person
Public Query  
Name  Dr Rahul Rathod 
Designation  Head - Ideation and Clinical Research 
Affiliation  Dr Reddys Laboratories 
Address  Medical Affairs Department, Dr Reddys Laboratories Ltd, 7-1-27,Ameerpet, Hyderabad

Hyderabad
TELANGANA
500016
India 
Phone  04049048400  
Fax  04049048800  
Email  Rahul.Rathod@drreddys.com  
 
Source of Monetary or Material Support  
Dr Reddys Laboratories Ltd, Medical Affairs Department, 7-1-27, Ameerpet Road, Ameerpet, Hyderabad TELANGANA 500016 India 
 
Primary Sponsor  
Name  Dr Reddys Laboratories 
Address  7-1-27, Ameerpet Hyderabad 500016 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NIL   
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 4  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr B Ravinder Reddy   Care Hospital  Consultant General Surgery and Surgical Gastroenterologist Road No 1 Banjara Hills, Hyderabad Telanagana 500034
Hyderabad
TELANGANA 		 04068159831

drbravinderreddy@gmail.com 
Dr Santosh Kumar Mohanlal Rathi  Criticare Superspeciality Hospitals  West, Eastern Express Hwy, next to Korum Mall, Sambhaji Nagar, Thane West, Thane, Maharashtra-400604
Mumbai
MAHARASHTRA 		 9821044577

drrathi_criticare@hotmail.com 
Dr Dharmesh Chandrakant Gandhi  Imperial Multispeciality Hospitals  Gat No. 1193, Pingle Pride, Near Radha swami Ashram, Chikhali, Pune- 411062, Maharashtra.
Pune
MAHARASHTRA 		 9028154345

dharmesh.gandhi012@gmail.com 
Dr Sambit Sahu  Krishna Institute of Medical Sciences  New Block, 1-8-31/1, Minister Road, Secunderabad, Hyderabad-500003
Hyderabad
TELANGANA 		 9989005763

sambit2k@yahoo.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 4  
Name of Committee  Approval Status 
Ethicare Ethics Committee   Approved 
Institutional Ethics Commitee, Care Hospitals  Approved 
Institutional Ethics Commitee, Kims Hospitals  Approved 
Institutional Ethics committee, Imperial Multispeciality Hospitals  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: Z209||Contact with and (suspected) exposure to unspecified communicable disease,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Celevida MaXX Enteral Nutrition Formula  Dose: CELEVIDA MAXX EN is an Enteral and oral nutritional supplement (Dr. Reddy’s Laboratories). This product is designed to deliver 1 to 2 Kcal/ml route of administration: -The Product is suitable for Enteral Feeding (Tube Feeding) and Oral Feeding Frequency of Dose: Day 1 - 2 Serves, Day 2 - 4 serves, Day 3 - 5 serves, Day 4 to 8 - 7 serves, Day 9 to Day 14 - 8 Serves 1 Serve - 50g Duration of therapy/intervention: Upto 14 days.  
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1) To study the impact of tube feeding supplement for achieving the target Macro Nutrients levels
2) To study the number of days required to reach the target Macro Nutrients levels 
 
ExclusionCriteria 
Details  1) To study the impact of EN supplement on total protein, micronutrient levels such as Zn, Vitamin C, Mg, potassium and Phosphorous.
2) To study the impact of tube feeding supplement events of abdominal pain, distension, vomiting and diarrhea after EN supplement
3) To assess the number and reasons of interruptions during the tube feeding and ease of titration of the formula
4) To assess the impact of tube feeding supplement on hematological parameters from baseline to the end of the study.
5) To evaluate the palatability of the formulation in patients shifted to ward’s, through oral supplementation 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
1) Ease of achieving desired target, no. of days required to achieve the target and no. of days of ICU stay.
 		 Baseline Visit, Day 1, Day 2, Day 3, Day 4-8, Day 8-14, End of study assessment. 
 
Secondary Outcome  
Outcome  TimePoints 
1) Improved vital status
2) No Interruptions to feeding
3) Absence of GIT complications- abdominal distention, vomiting and pain post starting of EN
4) Biochemical profile changes like blood glucose, BUN, LFT, Serum Pre albumin Levels
5) Palatability of the powder in ward patients 		 Baseline Visit, Day 1, Day 2, Day 3, Day 4-8, Day 8-14, End of study assessment. 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   05/12/2022 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  
This study is a prospective open label, single arm, multicenter, interventional, study to assess the efficacy and tolerability of early enteral nutrition in hospitalized patients at participating centers aged in between 18 to 75 years in about 40 adult patients that will be conducted in India. The primary objectives is to study the impact of tube feeding supplement (Early enteral nutrition formula) for achieving the target Macro Nutrients levels and the number of days required to reach the target Macro Nutrients levels in hospitalized patients who are hemodynamically stabilized and requiring Enteral feeding for minimum 3 days. A total of 40 adult patients admitted to hospital will be enrolled for the study across different centers in India. Ease of achieving desired target, no. of days required to achieve the target and no. of days of hospital stay from Day 1 till Day 14th will be assessed in the study endpoints.
 
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