drugset / Trial / NCT07037394

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

NCT07037394

Phase 4 Completed 252 enrolled Qurratul Ain Jamil
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

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

Drugs

EvaluationDrugModalityDoseRoute
Subject L-ornithine L-aspartate Other / unclassified 20 g Intravenous
Comparator Lactulose Other / unclassified 30 ml Oral
Subject Probiotic plus lactulose Unknown 2 g Oral
Subject Rifaximin Other / unclassified 550 mg Oral