CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 114 enrolled
Drug / intervention
Branch Chain Amino Acid +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05700695
NCT05700695Phase 1Completed
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Intravenous Branched-chain Amino Acids for Overt Hepatic Encephalopathy in Patients With Acute on Chronic Liver Failure - A Multi-centric Double-blind Randomized Controlled Trial

Post Graduate Institute of Medical Education and Research, Chandigarh·interventional·Posted Jan 26, 2023·Updated Jun 8, 2025

In Brief

A Phase 1 clinical trial evaluating Branch Chain Amino Acid and Lactulose for Hepatic Encephalopathy and Acute-On-Chronic Liver Failure. Completed, enrolled 114 participants across 1 site.

Detailed Summary

This multi-centric study analyses the effect of intravenous branched-chain amino acids (BCAA) on overt HE in patients with ACLF. The investigators aim to study the efficacy of combining intravenous BCAA with lactulose versus lactulose alone, ammonia measures, endotoxin, metabolomics, and cerebral edema in the medical management of overt HE in patients with ACLF. The study will also access the impact on overall survival and improvement in the grade of HE.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatic Encephalopathy, Acute-On-Chronic Liver Failure
CountriesIndia
CollaboratorsAmrita Institute of Medical Sciences & Research Center, Asian Institute of Gastroenterology, India, All India Institute of Medical Sciences, Bhubaneswar, Kalinga Institute of Medical Sciences, Bhubaneswar

Timeline

Phase 1CompletedFinished
2023202420252026
First PostedJan 26, 2023
Enrollment StartJan 17, 2023
Primary CompletionJun 5, 2025
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 3.4 years ago

Interventions

Branch Chain Amino Aciddrug

Intravenous branched chain amino acids will be given for 3 days to patients in experimental arm

Lactulosedrug

Oral lactulose will be given to patients in both arms