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Completed

NCT Number: NCT00740142

Efficacy of Combined Oral L-ornithine-L-aspartate and Lactulose in Patients With Hepatic Encephalopathy

Hypothesis: Is the combination of oral L-ornithine-L-aspartate and lactulose more efficacious than oral lactulose alone in treatment of hepatic encephalopathy? Study design; Randomized, double-blinded, placebo controlled trial

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Key information

Conditions

Hepatic Encephalopathy Brain Diseases Brain Diseases, Metabolic Central Nervous System Diseases Digestive System Diseases Hepatic Insufficiency Liver Diseases Liver Failure Metabolic Diseases Nervous System Diseases Nutritional and Metabolic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Siriraj Hospital, Mahidol University

Bangkok, 10700, Thailand

About this study

Data collection

  • Baseline characteristics
  • demographic data; age, gender, BW, height
  • cirrhosis; cause, duration, Child-Pugh score,complications of cirrhosis such as EV, ascites, hepatic encephalopathy, SBP etc.
  • comorbidity such as DM, CVA
  • After randomization
  • assessment of mental status (West-Haven criteria), Portal-systemic encephalopathy index (PSEI), number connection test, serum ammonia, asterixis at Day 1,3,7 and EEG at day 1,7
  • blood chemistry such as CBC, BUN, Creatinine, electrolyte, LFT, coagulogram, BS at Day 1,3,7
  • record adverse effect of drug such as nausea, vomiting, bloating.
  • record diet, frequency of bowel movement and stool pH
  • compliance

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Cirrhosis
  • Age 18-80
  • Hepatic encephalopathy grade II-III
  • Serum ammonia > 60 mcg/mL
  • Informed consent

Exclusion criteria

  • Recent GI hemorrhage
  • Severe sepsis
  • Degenerative CNS disease or major psychiatric illness
  • Serum creatinine > 1.5 mg/dl
  • Pregnancy or lactation
  • Poorly controlled DM
  • Insertion of TIPS
  • Received CNS depressants or hypnotics
  • Treatment with metronidazole, kanamycin or branched-chain amino acid
  • Hypersensitivity to L-ornithine-L-aspartate

Treatment and study plan

L-ornithine-L-aspartate and lactulose

Drug

L-ornithine-L-aspartate 1 sachet(3 grams)3 times a day for 7 days

placebo and lactulose

Drug

placebo 3 times a day for 7 days

Primary outcomes

  1. To assess improvement of mental status of the patients

    Time frame: 7 days

Secondary outcomes

  1. To assess improvement of number connection test, serum ammonia, EEG, asterixis and PSE index of the patients

    Time frame: 7 days

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Registry information

Official study title

Efficacy of Combined Oral L-ornithine-L-aspartate and Oral Lactulose in Patients With Hepatic Encephalopathy

Important dates

Study start
2008
Primary completion
2010
Study completion
2011
First posted
Aug 22, 2008
Registry last updated
Sep 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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