L-Ornithine L-Aspartate for prevention of hepatic encephalopathy

Secondary Prophylaxis of hepatic encephalopathy in cirrhosis:A double Blind randomized controlled trial of L-Ornithine L-Aspartate (LOLA) versus placebo - LOLA

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2014/08/004836

Enrollment

150

Registered

2014-08-07

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- Cirrhotics with Hepatic Encephalopathy

Interventions

Intervention1: L-Ornithine L-Aspartate (LOLA): L-Ornithine L-Aspartate (LOLA) 6 grams three times a day by oral route for six months will be given in cirrhotic patients of Hepatic Encephalopathy Co

Eligibility

Inclusion criteria

Inclusion criteria: •Liver cirrhosis (Child B or Child C class) •History of recovery from episod of overt hepatic encephalopathy (West-Haven grade 1 and above) in last 12 months. •No evidence of overt hepatic encephalopathy at the time of enrollment

Exclusion criteria

Exclusion criteria: •History of taking lactulose, rifaximin, neomycin, metronidazole, HepaMerz or probiotics in past 6 weeks •Alcohol intake during past 6 weeks •Receiving secondary prophylaxis for spontaneous bacterial peritonitis •Previous transjugular intrahepatic portosystemic shunts or shunt surgery •Significant comorbid illness such as heart, respiratory or kidney failure, and neurological disease such as Alzheimerâ??s disease, Parkinsonâ??s disease and non hepatic metabolic encephalopathies •Receiving psychoactive drugs such as antidepressants and sedatives •Foreseeable risk of alcohol consumption during the study conduct. •Hepatocellular carcinoma •Anemia (Hemoglobin •Electrolyte abnormality (Serum sodium •Intercurrent infection such as spontaneous bacterial peritonitis •Pregnancy, breast feeding or refusal to use a contraceptive method in women of child bearing age •Patients with foreseeable compliance

Design outcomes

Primary

Measure	Time frame
â?¢Superiority of L-Ornithine L-Aspartate compared to placebo in the efficacy of prevention of overt HE recurrence.Timepoint: one week to 3 months	—

Secondary

Measure	Time frame
â?¢Time taken for first breakthrough episode of overt hepatic encephalopathy â?¢Time to first overt hepatic encephalopathy-related hospital admission Timepoint: one week to 3 months	—

Countries

India

Contacts

Public ContactDr B C Sharma

G B Pant Hospital, New Delhi

drbcsharma@hotmail.com

Outcome results

None listed

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