| CTRI Number |
CTRI/2024/02/062513 [Registered on: 12/02/2024] Trial Registered Prospectively |
| Last Modified On: |
06/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Can polyethylene glycol solution be used as an alternative to lactulose in patients of hepatic encephalopathy ? |
|
Scientific Title of Study
|
Comparative Effectiveness Of Polyethylene Glycol Electrolyte Solution Versus Lactulose For Treatment Of Hepatic Encephalopathy : A Single Blind, Randomised Control Clinical 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 Aditi Agrawal |
| Designation |
PG Resident |
| Affiliation |
Dr. S.N. Medical College, Jodhpur |
| Address |
Department of Pharmacology, Dr. S.N. Medical College, Jodhpur
Jodhpur
RAJASTHAN
342003
India |
| Phone |
9874823660 |
| Fax |
|
| Email |
adititanu010@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Saurabh Jain |
| Designation |
DM Resident |
| Affiliation |
Dr. S.N. Medical College, Jodhpur |
| Address |
Department of Gastroenterology, MDM Hospital, Dr. S.N. Medical College, Jodhpur
Jodhpur
RAJASTHAN
342003
India |
| Phone |
9509470890 |
| Fax |
|
| Email |
jainsaurabh0890@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anusuya Gehlot |
| Designation |
Senior Professor & HOD, Department of pharmacology, |
| Affiliation |
Dr. S.N. Medical College, Jodhpur |
| Address |
Department of pharmacology, Dr. S.N. Medical College, Jodhpur
Jodhpur
RAJASTHAN
342003
India |
| Phone |
9413256424 |
| Fax |
|
| Email |
anusuyagehlot@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [Not applicable] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| dr aditi agrawal |
mathuradas mathur hospital |
room no. 104, first floor, department of gastroenterology
Jodhpur
RAJASTHAN |
9874823660
adititanu010@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F99||Mental disorder, not otherwise specified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Lactulose For Treatment Of Hepatic Encephalopathy |
90 ml of Lactulose dissolved in 750 ml of water administered orally by mouth or nasogastric tube (three doses within 24 hrs) continued up to 72 hours or until patient discharge, whichever comes first |
| Comparator Agent |
Polyethylene Glycol Electrolyte for treatment of hepatic encephalopathy |
70gm of PEG will be dissolved in 750 ml of water and will be given over 24 hrs as 3 doses orally by mouth or Nasogastric tube and will continue up to 72 hours or until patient discharge, whichever comes first |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients with any grade of hepatic encephalopathy
(grade1-grade4)
2.Patients with chronic liver disease and acute on chronic liver failure of any cause. |
|
| ExclusionCriteria |
| Details |
patients with acute liver failure, suspected intestinal obstruction, pregnancy and lactation, uncontrolled infection and hemodynamically unstable and received more than 1 dose of lactulose prior to enrollment |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1 or more scale improvement in HE grades at 24 hours, 48 hours, 72 hours and at time of discharge using Hepatic Encephalopathy Scoring Algorithm (HESA) ranging from 0 to 4 |
12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| overall length of stay (LOS), serum ammonia concentration and time to HE resolution. |
12 months |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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 4 |
|
Date of First Enrollment (India)
|
17/02/2024 |
| 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="1"
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 - NO
|
|
Brief Summary
|
lactulose has been recommended as a guide to HE for decades, which is able to reduce the intestinal production and absorption of ammonia generated by catharsis and intestinal microbial metabolism. although lactulose is the standard therapy for gut catharsis in HE patients, PEG can also relieve constipation and reduce the absorption of ammonia. PEG is an iso-osmotic laxative that is metabolically inert and ablr to bind water molecules, thereby increasing intraluminal water retention. PEG is not metabolized by colonic bacteria. ingestion og PEG leads to an increase in stool volume and softer stools, which may become liquid depending on the volume of PEG consumed. it is the most widely used preparation to clean the bowel before colonoscopy. PEG is being studied for treatment of HE in patients with cirrhosis and limited research has shown positive effects. there are very few studies comparing lactulose and PEG in HE, and indian data on this comparison is lacking. since PEG is a safe, affordable, widely available and highly effective osmotic laxative, we hypothesize that if immediate catharsis of gut is important in the treatment of acute HE, then PEG may be superior to lactulose in this capacity. thus, this study aims to determine the effect of PEG compared with lactulose for HE therapies by conducting a randomised control trial |