ClinicalTrials.gg
Status unknownNCT03448770Updated Feb 28, 2018

To Compare Efficacy and Safety of Lactulose Versus Polyethylene Glycol for Treatment of Overt Hepatic Encephalopathy in Cirrhotics.

An interventional study of PEG- 17 gm sachet and Lactulose : 20-30gm in Cirrhosis, sponsored by Institute of Liver and Biliary Sciences, India. Status unknown at 1 site in India. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2018-02-28.

Sponsored by Institute of Liver and Biliary Sciences, India · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Feb 2018), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 6 months after the study started (first participant enrolled Aug 2017, registered Feb 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
110
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

All patients presenting to the emergency department of Institute of Liver and Biliary Sciences with known cirrhosis and hepatic encephalopathy with grade II will be included in the study. The patient will be randomized into one of the two arms of lactulose or polyethylene glycol. The patient on the lactulose arm will be administered 20 to 30 g of lactulose orally or by nasogastric tube (3 or more doses within 24 hours ) or if oral intake was not possible or inadequate. The Dose will be repeated to ensure 3-4 loose motions per day. The Polyethylene Glycol group will get 17 gm of PEG (Polyethylene Glycol) administered orally or via nasogastric tube. PEG (Polyethylene Glycol)will be administered in 3-4 doses in 24 hours to ensure 3-4 loose stools per day.

02

Conditions studied

  • Cirrhosis

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03

In context

Fibrosis

1,270 studies on the registry are indexed under Fibrosis; 276 are open to participants now.

This study's planned enrollment of 110 is above the median of 63 across 840 interventional studies indexed under Fibrosis.

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Lead sponsor

Institute of Liver and Biliary Sciences, India is the lead sponsor of 302 studies on the registry; 87 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Documented cirrhosis with any underlying etiology
  2. Hepatic encephalopathy of grade II and above
  3. 18 to 65 years of age

Exclusion criteria

Exclusion Criteria:

  1. Acute change in mental status due to a diagnosis other than hepatic encephalopathy
  2. Patients who have received lactulose as an anticoma measure before enrollment
  3. Patient who have developed encephalopathy post bleed
  4. Patients with gut paralysis
  5. Patients with tense ascites
  6. Patients with altered sensorium due to organic brain disease.
  7. Patients with coexistent psychiatric illness that may hamper the proper assessment of hepatic encephalopathy
  8. Hemodynamic instability obviating vasopressors for resuscitation
  9. Acute liver failure defined as severe acute liver injury with encephalopathy and (INR)≥1.5 in a patient without pre-existing liver disease
  10. Refusal of consent
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

INR, PT and aPTT (clotting tests)

Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.

Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
110 participants (estimated)

Study arms

  • Active comparator
    Lactulsoe

    Lactulose : 20-30gm 2-3 doses per day

    Drug: Lactulose : 20-30gm

  • Experimental
    Polyethlene Glycol

    PEG (Polyethlene Glycol)- 17 gm sachet 3-4 times per day

    Drug: PEG- 17 gm sachet

Interventions

  • DrugPEG- 17 gm sachet

    PEG- 17 gm sachet 3-4 times per day

  • Lactulose : 20-30gm

06

What researchers measure

Primary outcomes

  1. Complete reversal of hepatic encephalopathy in both groups.

    Complete reversal is defined as Grade 0 Encephalopathy

    Time frame: 3 days

Secondary outcomes

  1. Improvement in hepatic encephalopathy by two grades in both groups

    Time frame: 3 days

  2. Length of Intensive Care Unit stay in both groups

    Time frame: 28 days

  3. Adverse events in both groups

    Time frame: 3 days

  4. Presence of encephalopathy changes in Electroencephalography in both groups

    Time frame: 3 days

07

Study locations

1 of 1 sites recruiting
  • Institute of liver and Biliary Sciences
    New Delhi, Delhi 110070, India
    Recruiting
    • Dr Abhinav Verma, MD · Contactabhinav.3183@gmail.com · 01146300000
    • Dr Abhinav Verma, MD · Principal investigator
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 28, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03448770
Responsible party
Sponsor
First posted
Feb 28, 2018
Start date
Aug 1, 2017
Primary completion
Jul 31, 2018 (estimated)
Completion
Jul 31, 2018 (estimated)
Last update
Feb 28, 2018

Study contacts

Dr Abhinav Verma, MD
Contact
abhinav.3183@gmail.com
01146300000

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.

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