NCT07037394

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

Comparison of Efficacy of Rifaximin, Probiotics and LOLA (L-Ornithine L-Aspartate) in Overt Hepatic Encephalopathy: A Randomized, Phase-IV, Lactulose Controlled Clinical Trial.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 252 (actual)
• Sponsor: Qurratul Ain Jamil · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This clinical trial aim to compare the efficacy of four groups which are group A (lactulose) as controlled group, group B (rifaximin + lactulose), group C (probiotics + lactulose)and group D (LOLA (L-Ornithine L-Aspartate) + lactulose) for treating overt hepatic encephalopathy. Primary objective: The primary objective of our trial will be to compare the grade reversal in overt hepatic encephalopathy patients from the time of trial participation till the end of trial treatment (day 5) according to West Heaven Criteria in both control and interventional groups. Secondary objectives: 1. To find the length of hospital stay and recovery time (in days) from hepatic encephalopathy in both control and interventional groups. 2. Monitoring of Adverse drug reactions in both control and interventional groups. 3. To assess the mortality in both control and interventional groups. This trial is single-centered, parallel, multi-arm, 1:1:1:1 randomized, unblinded, lactulose controlled superiority clinical trial comparing the efficacy of four groups which are group A (lactulose) as controlled group, group B (rifaximin + lactulose), group C (probiotics + lactulose) and group D (LOLA (L-Ornithine L-Aspartate) + lactulose) for the treatment of overt hepatic encephalopathy. Framework/hypothesis: The experimental group B (rifaximin + lactulose), group C (probiotics + lactulose) and group D (LOLA (L-Ornithine L-Aspartate) + lactulose) are superior to control group A lactulose alone in the reversal of grades for patients of hepatic encephalopathy.

Conditions

• Overt Hepatic Encephalopathy

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-12-02
• Primary completion: 2025-04-21
• Completion: 2025-04-30
• First posted: 2025-06-25
• Last updated: 2025-06-25

Locations

1 site across 1 country: Pakistan