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CTRI Number  CTRI/2024/02/062542 [Registered on: 12/02/2024] Trial Registered Prospectively
Last Modified On: 08/02/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [IMMEDIATE FEEDING AND HUNGER BASED FEEDING]  
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   A Multi-Arm Randomized Controlled Trial Evaluating Immediate Oral Refeeding to Conventional Oral Refeeding and Hunger Based Refeeding in Patients with Mild to Moderate Acute Pancreatitis. 
Scientific Title of Study   Immediate Oral Refeeding Compared to Hunger Based Refeeding and Conventional Oral Refeeding in Patients with Mild and Moderate Acute Pancreatitis - A Multi-Arm 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  Dr Chinthi Reddy Pranaypal Reddy 
Designation  Junior Resident 
Affiliation  Jawaharlal Institute of Postgraduate Medical Education and Research 
Address  Surgery Office, 2nd floor, Old block, JIPMER, Gorimedu, Pondycherry

Pondicherry
PONDICHERRY
605009
India 
Phone    
Fax    
Email  chpranaypal@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Suresh Kumar S 
Designation  Professor 
Affiliation  Jawaharlal Institute of Postgraduate Medical Education and Research 
Address  Surgery Office, 2nd floor, Old block, JIPMER, Gorimedu, Pondicherry

Pondicherry
PONDICHERRY
605009
India 
Phone  9788637893  
Fax    
Email  drsureshkumar08@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Suresh Kumar S 
Designation  Professor 
Affiliation  Jawaharlal Institute of Postgraduate Medical Education and Research 
Address  Surgery office, 2nd floor, Old block, JIPMER, Gorimedu, Pondicherry.

Pondicherry
PONDICHERRY
605009
India 
Phone  9788637893  
Fax    
Email  drsureshkumar08@yahoo.com  
 
Source of Monetary or Material Support  
Jawaharlal Institute of Postgraduate Medical Education and Research 
 
Primary Sponsor  
Name  Jawaharlal Institute of Postgraduate Medical Education and Research 
Address  Surgery office, 2nd floor, Old block, Gorimedu, Pondicherry. 
Type of Sponsor  Government 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 Chinthi Reddy Pranaypal Reddy  Jawaharlal Institute of Postgraduate Medical Education and Research  Surgery office, 2nd floor, Old block
Pondicherry
PONDICHERRY 		 8096046657

chpranaypal@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITEE INTERVENTIONAL STUDIES  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K859||Acute pancreatitis, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  CONVENTIONAL REFFEDING IN PATIENTS WITH MILD AND MODERATE ACUTE PANCREATITIS  Patients with mild or moderate acute pancreatitis will be started on orals based on conventional practice. Patient will be started on orals once his pain in abdomen decreased and laboratory values become normal. 
Intervention  HUNGER BASED REFEEDING IN PATIENTS WITH MILD AND MODERATE ACUTE PANCREATITIS  Patients with mild or moderate acute pancreatitis will be started on orals when patient has the appetite. Patient will receive liquids intially, then will be gradually escalated to normal diet. Patient will receive the diet thrice daily and will be encouraged to take adequate orals to meet daily calorie requirement. This will be given till patient is discharged. 
Intervention  IMMEDIATE REFEEDING IN PATIENTS WITH MILD AND MODERATE ACUTE PANCREATITIS  Patients with mild and moderate acute pancreatitis will be started on orals immediately on presentation. Patient will receive low fat solid diet immediately on presentation and will be taking the diet thrice daily. Daily calorie intake will be calculated and patient will be encouraged to take the diet to meet daily calorie requirement. This will be continued till patient is discharged. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Adequate cognitive capacity 
 
ExclusionCriteria 
Details  9. Severe AP on admission (predicted by presence of SIRS at admission or Patients presenting in shock or sepsis, needing ventilator support).
10. Patients who are unable to undergo USG/CECT within 12hours of admission
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
LENGTH OF HOSPITAL STAY  At the time of discharge 
 
Secondary Outcome  
Outcome  TimePoints 
Complications that arise from pancreatitis  30 DAYS 
Relapse of abdominal pain  3 MONTHS 
Laboratory parameters   AT THE TIME OF ADMISSION 
Diet intolerance after starting refeeding  AFTER STARTING FEEDS 
Requirement of surgical and non-surgical intervention  3 MONTHS 
ICU admission/ mortality/ readmission   3 MONTHS 
 
Target Sample Size   Total Sample Size="186"
Sample Size from India="186" 
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 2/ Phase 3 
Date of First Enrollment (India)   20/02/2024 
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="3"
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

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

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

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

  6. For how long will this data be available start date provided 01-04-2024 and end date provided 31-03-2029?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

After obtaining informed consent, the patients with mild and moderate will be randomly allocated to either the IORF, HBORF or CORF group. Patients in the IORF group will be started on a low-fat solid diet immediately upon hospital admission, regardless of symptoms or laboratory parameters. Patients in HBORF group, oral refeeding in the form of oral clear liquid will be commenced once they feel hungry regardless of the pain abdomen and laboratory parameters. For patients in the CORF group, oral diet will be re-introduced in a stepwise manner from fasting, then to clear liquids, and finally, a low-fat solid diet when the patients meet the following criteria: absence of abdominal pain and presence of peristalsis, pancreatic enzymes twofold below the reference limit, blood leukocyte level <15000/mm3, and decreased C-reactive protein level. 


 
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