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Search / Trial NCT00433368

Efficacy of L-Ornithine-L-Aspartate in Cirrhotics With Hepatic Encephalopathy

Launched by AGA KHAN UNIVERSITY · Feb 8, 2007

Trial Information

Current as of May 09, 2025

Completed

Keywords

L Ornithine L Aspartate, Porto Systemic Encephalopathy, Hepatic Encephalopathy, Liver Cirrhosis, Mental State

ClinConnect Summary

There is no effective treatment available for hepatic encephalopathy at the moment; therefore we aimed to check the efficacy and safety of L-ornithine L-aspartate(LOLA). It provides critical substrates for ureagenesis and glutamine synthesis, the two primary mechanisms by which the body rids itself of excess ammonia. Ornithine is a specific activator of ornithine carbamyl transferase and carbamylphosphate synthetase, and, in addition, is a substrate for ureagenesis. These reactions are carried out mainly in the periportal portion of the hepatic lobules. Aspartate and ornithine, after conver...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Cirrhosis, diagnosed on the basis of clinical findings, sonographic, and/or histologic basis,
  • Patients \>14 years, with HE grades 1 to 4 according to West Haven Criteria,
  • Hyperammonemia (fasting venous blood ammonia level \>60 µmol/l), and
  • Patients with a single reversible precipitating factor of HE such as constipation, hypokalemia, urinary tract infection, respiratory tract infection, spontaneous bacterial peritonitis (SBP), dehydration, or none.
  • Exclusion Criteria:
  • hepatocellular carcinoma,
  • severe septicemia,
  • active gastrointestinal bleeding,
  • hepatorenal syndrome,
  • acute superimposed liver injury,
  • advanced cardiac or pulmonary disease and end stage renal failure,
  • patients with minimal HE
  • patients taking sedatives, antidepressants, or benzodiazepines and
  • patients with chronic HE on metronidazole or lactulose prior to admission.

About Aga Khan University

Aga Khan University (AKU) is a distinguished institution dedicated to improving health and education across developing regions. Established in 1983, AKU is recognized for its commitment to research excellence, particularly in clinical trials that address pressing health issues in diverse populations. With a focus on advancing medical knowledge and practice, AKU's clinical trial initiatives are designed to foster innovative solutions and enhance patient care. The university collaborates with various local and international partners, leveraging its multidisciplinary expertise to conduct rigorous research that informs public health policy and improves health outcomes in communities served by its facilities.

Locations

Karachi, Sind, Pakistan

Patients applied

0 patients applied

Trial Officials

Wasim Jafri, MD; FRCP

Study Chair

Chairman Department of Medicine, Aga Khan University Hospital

Shahab Abid, MD

Principal Investigator

Associate Professor, Department of Medicine, Aga Khan University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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