Role of L-Ornithine L-Aspartate in improving acute encephalopathy (altered sensorium) in patients with Liver Cirrhosis

Efficacy of intravenous â??L-ornithine L-aspartateâ?? in reversal of overt acute hepatic encephalopathy in patients with liver cirrhosis: a prospective, randomized, double-blind, placebo controlled trial - HEAL (Hepatic Encephalopathy and LOLA)

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2013/02/003360

Enrollment

164

Registered

2013-02-07

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Hepatic cirrhosis

Interventions

Intervention1: L-Ornithine L-Aspartate: L-Ornithine L-Aspartate, 30 grams per day as intravenous infusion over 24 hours Control Intervention1: Placebo: Placebo ampules as intravenous infusion over 24

Eligibility

Inclusion criteria

Inclusion criteria: a. Hepatic cirrhosis based on clinical, biochemical, radiological and/or histological data. b. Patients with overt acute grade 2, 3 and 4 HE, according to the West Haven criteria. c. Age of patient >18 years d. Patients with or without a precipitating factor for the HE.

Exclusion criteria

Exclusion criteria: a. Patients who are terminally ill (End Stage Liver Disease, MELD more than 15) b. Chronic HE, on Lactulose or antibiotics c. Acute superposed liver injury (hepatitis) or acute on chronic liver failure d. Severe septicemia with shock e. Hepatocellular carcinoma f. Wilsonâ??s disease as the etiological factor of liver disease g. Advanced cardiac or pulmonary disease h. Acute renal failure or end stage renal disease i. Neuro-degenerative disease or major psychiatric illness j. Patients on sedatives or antidepressants k. Pregnancy or breastfeeding

Design outcomes

Primary

Measure	Time frame
Mental state gradeTimepoint: 5 days	—

Secondary

Measure	Time frame
Blood ammonia levels Timepoint: 5 days;Hospital stayTimepoint: 4 weeks;MortalityTimepoint: 4 weeks	—

Countries

India

Contacts

Public ContactDr Sandeep Singh Sidhu

D.M.C. and Hospital

dmcgastro@in.com9814025085

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026