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CTRI Number  CTRI/2025/08/093733 [Registered on: 27/08/2025] Trial Registered Prospectively
Last Modified On: 26/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparison of two laxatives, lactulose and polyethylene glycol, in early resolution of hepatic encephalopathy in children with acute liver failure. 
Scientific Title of Study   Comparison Of Lactulose versus Polyethylene Glycol In Management Of Hepatic Encephalopathy In Pediatric Acute Liver Failure: A 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  Dibyendu Sekhar Das 
Designation  Senior Resident 
Affiliation  AIIMS Rishikesh 
Address  Dean Office, AIIMS Rishikesh Rishikesh Uttarakhand

Dehradun
UTTARANCHAL
249203
India 
Phone  9843591134  
Fax    
Email  always.dsd@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Nowneet Kumar Bhat 
Designation  Professor and Head of Department, Pediatrics 
Affiliation  AIIMS Rishikesh 
Address  Department of Pediatrics Level 6, AIIMS Rishikesh Rishikesh Uttarakhand

Dehradun
UTTARANCHAL
249203
India 
Phone  9412051110  
Fax    
Email  drnmbhat@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dibyendu Sekhar Das 
Designation  Senior Resident 
Affiliation  AIIMS Rishikesh 
Address  Dean Office, AIIMS Rishikesh Rishikesh Uttarakhand


UTTARANCHAL
249203
India 
Phone  9843591134  
Fax    
Email  always.dsd@gmail.com  
 
Source of Monetary or Material Support  
Department of Pediatrics, All India Institute of Medical Sciences, Rishikesh. Veerbhadra, Rishikesh Uttarakhand - 249203 India 
 
Primary Sponsor  
Name  AIIMS Rishikesh 
Address  AIIMS Rishikesh, Veerbhadra, Rishikesh, Uttarakhand 249203 
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 Dibyendu Sekhar Das  AIIMS Rishikesh  AIIMS Rishikesh, Veerbhadra, Rishikesh, Uttarakhand 249203
Dehradun
UTTARANCHAL 		 09843591134

always.dsd@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AIIMS Rishikesh Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K720||Acute and subacute hepatic failure, (2) ICD-10 Condition: K729||Hepatic failure, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  LACTULOSE ORAL SOLUTION  Initial starting dose 1 mL per kg per dose Q 12 hourly (max 90 mL per day) Target 3-5 stools per day Dose Titration: 0.5 mL per kg per dose up or down titration. 0 stools in 24 hours, increase dose to next higher level and add lactulose enema. 1 to 2 stools in 24 hours,increase dose to next higher level 3 to 5 stools in 24 hours, continue same dose more than 5 stools in 24 hours, reduce dose to lower level Route Oral or NGT (nasogastric tube) Maximum duration till resolution of HE, discharge from hospital or death whichever earlier 
Intervention  POLYETHYLENE GLYCOL ORAL SOLUTION  Initial 1g per kg first dose, followed by 0.5g per kg every 12 hourly Titration 0.25 g per kg per dose (maximum 100g per day) Dose Titration: 0.5 mL per kg per dose up or down titration. 0 stools in 24 hours, increase dose to next higher level and add lactulose enema. 1 to 2 stools in 24 hours, increase dose to next higher level 3 to 5 stools in 24 hours, continue same dose more than 5 stools in 24 hours, reduce dose to lower level Route Oral or NGT (nasogastric tube) Target 3 to 5 stools PER day Maximum duration till resolution of HE, discharge from hospital or death whichever earlier 
 
Inclusion Criteria  
Age From  1.00 Month(s)
Age To  18.00 Year(s)
Gender  Both 
Details  Children with signs and symptoms of liver dysfunction fulfilling all the
following criteria will be included:
1. Age: 1 month - 18 years
2. INR more than or equal to 1.5 (without vitamin K deficiency)
3. Evidence of hepatic encephalopathy (any grade)
4. Acute onset liver dysfunction (<8 weeks)
5. Written informed consent from parent/guardian
6. Assent when age-appropriate 
 
ExclusionCriteria 
Details  Children fulfilling the inclusion criteria but having any of the following will be
excluded:
o Known chronic liver disease
o Prior neurological disorders affecting HE assessment 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Time to improvement defined as:
Decrease by at least one grade on West Haven Criteria OR PALFSG Criteria
o Measured from first dose administration
o Improvement must be sustained for AT LEAST 12 hours
o Assessment by blinded evaluator (DM Pediatric Gastroenterology
trainee in the study department, not directly involved in the trial) 		 at admission, and then at every 8 hour interval from admission till decrease in hepatic encephalopathy by 1 grade is noted. 
 
Secondary Outcome  
Outcome  TimePoints 
TIME TO COMPLETE RESOLUTION OF HEPATIC ENCEPHALOPATHY  24 HOURS, 48 HOURS AND 72 HOURS SINCE ADMISSION 
NEED FOR MECHANICAL VENTILATION  DISCHARGE OR DEATH 
NEED AND LENGTH OF PICU STAY  DISCHARGE OR DEATH 
DURATION OF HOSPITAL STAY  DISCHARGE OR DEATH 
28 DAY SURVIVAL STATUS AND LIVER FUNCTION  28 DAYS POST DISCHARGE 
 
Target Sample Size   Total Sample Size="56"
Sample Size from India="56" 
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)   15/09/2025 
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="6"
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-identification.

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

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

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

  6. For how long will this data be available start date provided 01-01-2027 and end date provided 31-12-2031?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  
This study will systematically assess the comparative efficacy of PEG and lactulose in PALF-associated HE, addressing a critical gap in pediatric hepatology and aiming to provide evidence-based guidance for management in PALF.
In this study, children with PALF will be randomised to receive either laxative Lactulose or Polyethylene glycol and time to improvement in HE will be assessed and compared, with the hypothesis being that Polyethylene glycol is superior to lactulose in earlier resolution of hepatic encephalopathy in PALF.
 
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