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Intravenous Branched Chain Amino Acids for Hepatic Encephalopathy in ACLF

NCT04238416 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2022-08-16

No results posted yet for this study

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.

Conditions

  • Hepatic Encephalopathy
  • Acute-On-Chronic Liver Failure

Interventions

DRUG

Branched chain amino acid

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

DRUG

Lactulose

Oral lactulose will be given to patients in both arms

Sponsors & Collaborators

  • Post Graduate Institute of Medical Education and Research, Chandigarh

    lead OTHER

Principal Investigators

  • Madhumita Premkumar, MD, DM · Post Graduate Institute of Medical Education and Research, Chandigarh

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-01
Primary Completion
2021-12-30
Completion
2021-12-30

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04238416 on ClinicalTrials.gov