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Intravenous BCAA for HE in ACLF (BCAA-HE-ACLF)

NCT05700695 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 114

Last updated 2025-06-08

No results posted yet for this study

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.

Conditions

  • Hepatic Encephalopathy
  • Acute-On-Chronic Liver Failure

Interventions

DRUG

Branch 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

  • Amrita Institute of Medical Sciences & Research Center

    collaborator OTHER

  • Asian Institute of Gastroenterology, India

    collaborator OTHER

  • All India Institute of Medical Sciences, Bhubaneswar

    collaborator OTHER

  • Kalinga Institute of Medical Sciences, Bhubaneswar

    collaborator UNKNOWN

  • Post Graduate Institute of Medical Education and Research, Chandigarh

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2023-01-17
Primary Completion
2025-06-05
Completion
2025-06-05

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 NCT05700695 on ClinicalTrials.gov