CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 70 enrolled
Drug / intervention
Branched 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/NCT04238416
NCT04238416Phase 1Completed
CompareCT.gov

Efficacy of Lactulose Plus Intravenous Branched Chain Amino Acids Versus Lactulose Alone in Patients of Acute on Chronic Liver Failure With Overt Hepatic Encephalopathy: A Prospective Randomized Clinical Trial

Post Graduate Institute of Medical Education and Research, Chandigarh·interventional·Posted Jan 23, 2020·Updated Aug 16, 2022

In Brief

A Phase 1 clinical trial evaluating Branched chain amino acid and Lactulose for Hepatic Encephalopathy and Acute-On-Chronic Liver Failure. Completed, enrolled 70 participants across 1 site.

Detailed Summary

This study analyses the effect of intravenous branched chain amino acids (BCAA) on overt HE in patients with ACLF. The investigators plan to study the efficacy of combining intravenous BCAA with lactulose versus lactulose alone in the medical management of overt HE in patients with ACLF and its impact on overall survival and improvement in grade of HE.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatic Encephalopathy, Acute-On-Chronic Liver Failure
CountriesIndia
Collaborators--

Timeline

Phase 1CompletedFinished
2020202120222023202420252026
First PostedJan 23, 2020
Enrollment StartNov 1, 2019
Primary CompletionDec 30, 2021
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 6.4 years ago

Interventions

Branched 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