ARGO-HEC
Comparison of Efficacy of Rifaximin, Probiotics and LOLA (L-Ornithine L-Aspartate) in Overt Hepatic Encephalopathy: A Randomized, Phase-IV, Lactulose Controlled Clinical Trial.
Sponsor study identifier
interventional
252
1 country
1
Study Start
December 2, 2024
Actual (reported)Primary Completion
April 21, 2025
Actual (reported)Study Completion
April 30, 2025
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 30, 2025
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 2, 2024
Actual (reported)April 21, 2025
Actual (reported)April 30, 2025
Actual (reported)June 9, 2025
Actual (reported)June 25, 2025
Actual (reported)Number of participants of overt hepatic encephalopathy are treated by observing reversal in grades by using West Haven Criteria.
To compare the efficacy of group B (rifaximin + lactulose), group C (probiotics + lactulose) and group D (LOLA (L-Ornithine L-Aspartate) + lactulose) with group A (lactulose) as controlled group for the treatment of overt hepatic encephalopathy, grade reversal is examined from the time of participation in the trial till the end of treatment (day 5) according to West Heaven Criteria. The West Haven criteria are a widely used system for classifying the severity of hepatic encephalopathy. It grades the condition from Grade 0 (minimal or no symptoms) to Grade 4 (coma) based on the patient's level of consciousness, intellectual function, and behavior.
From the time of enrollment till the end of treatment (day 5) in the trial.
Time of recovery from encephalopathy (Days)
Time of participation in the study assessed up to 5 days.
Liver disease severity
time of participation in the trial till the end of treatment (day 5)
length of hospital days
time of participation in the study till the patient is discharged or died or till 28 days whichever occur earlier.
Participant will receive lactulose syrup (120ml), 30ml (three times a day) TDS orally or by nasogastric tube (NG) for 5 days.
Participant will receive Rifaximin tablet 550mg (twice daily) BID with lactulose syrup 30ml (three times a day) TDS orally or by nasogastric tube (NG) for 5 days
Participant will receive Probiotic sachet 2g (twice daily) BID with lactulose syrup 30ml (three times a day) TDS orally or by nasogastric tube (NG) for 5 days
Probiotic and lactulose will be administered per the dose and schedule specified in the arms.
Rifaximin and lactulose will be administered per the dose and schedule specified in the arms.
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Partially structured registry wording
Probiotic plus lactulose
Part of this registry label remains unresolved and is preserved as written. Recognized names are text references, not confirmed ingredients. Composition, doses and actual exposure are not established.
Names joined in the label
1 recognized name reference in the wording; 1 unresolved part.
Grouped treatment entry
Rifaximin plus lactulose
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordBahawal Victoria Hospital
Bahawalpur, Punjab Province, 63100, Pakistan
Shahbaz A, Jamil Q, Iqbal SM, Jamil MN, Khan JA, Aufy M. Comparison of efficacy of rifaximin, probiotics and L-ornithine L-aspartate in overt hepatic encephalopathy: a randomized, phase IV, lactulose controlled clinical trial. Trials. 2025 Nov 21;26(1):534. doi: 10.1186/s13063-025-09173-2.
QurratulAin Jamil, PhD
The Islami University of Bahawalpur
252 participants (actual enrollment reported by the registry).
First Submitted
June 9, 2025
First Posted
June 25, 2025
Study Start
Group D: LOLA (L-Ornithine L- Aspartate) concentrate for infusion (5g/10ml = 5g LOLA in 10ml clear solution) + lactulose. Dose: 4 ampoules (40ml) of LOLA 20g of drug diluted in 460ml of 5% dextrose was administered as an intravenous infusion at a rate of 21ml /hour (over 24 hours for 5 days) with lactulose syrup 30ml (three times a day) TDS orally or by nasogastric tube (NG)
LOLA and lactulose will be administered per the dose and schedule specified in the arms.
Lactulose will be administered per the dose and schedule specified in the arms.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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December 2, 2024
Actual (reported)Primary Completion
April 21, 2025
Actual (reported)Study Completion
April 30, 2025
Actual (reported)Last Updated
June 25, 2025
Record last verified: 2025-06
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Source: ClinicalTrials.gov.
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