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A Trial for Comparing Rifaximin, Probiotic and L-ornithine- L Aspartate With Lactulose in Overt Hepatic Encephalopathy.

NCT07037394 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 252

Last updated 2025-06-25

No results posted yet for this study

Summary

The goal of this trial is to learn if drugs in group A, B, C and D works to treat reversal of grades in people with overt hepatic encephalopathy. It will also provide information regarding safety of drugs in group A, B, C and D. The main question it aim to answer is:

Which study group is better in treating people of overt hepatic encephalopathy. Researchers will compare experimental group B (rifaximin + lactulose), group C (probiotics + lactulose) and group D (LOLA (L-Ornithine L-Aspartate) + lactulose) to control group A lactulose alone in the reversal of grades for people of hepatic encephalopathy.

Participants will:

Take drug from time of participation in the trial till the end of treatment (day 5) and grade reversal will be observed.

Conditions

  • Overt Hepatic Encephalopathy

Interventions

DRUG

Probiotic plus lactulose

Probiotic and lactulose will be administered per the dose and schedule specified in the arms.

DRUG

Rifaximin plus lactulose

Rifaximin and lactulose will be administered per the dose and schedule specified in the arms.

DRUG

L-ornithine-L-aspartate plus latulose

LOLA and lactulose will be administered per the dose and schedule specified in the arms.

DRUG

Lactulose

Lactulose will be administered per the dose and schedule specified in the arms.

Sponsors & Collaborators

  • Qurratul Ain Jamil

    lead OTHER

Principal Investigators

  • QurratulAin Jamil, PhD · The Islami University of Bahawalpur

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-02
Primary Completion
2025-04-21
Completion
2025-04-30

Countries

  • Pakistan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07037394 on ClinicalTrials.gov