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Oral Acetyl-L-Carnitine Therapy Reduces Fatigue In Hepatic Encephalopathy

This study has been completed.
Information provided by:
University of Catania Identifier:
First received: October 18, 2010
Last updated: NA
Last verified: December 2000
History: No changes posted
The aim of this study was to evaluate the effect of exogenous ALC on the both physical and mental fatigue in mild and moderate encephalopatic patients.

Condition Intervention
Hepatic Encephalopathy
Dietary Supplement: ACETYL-L-CARNITINE
Drug: placebo

Study Type: Interventional

Resource links provided by NLM:

Further study details as provided by University of Catania:

Study Start Date: June 2002
Estimated Study Completion Date: December 2006
Arms Assigned Interventions
Experimental: ACETYL-L-CARNITINE Dietary Supplement: ACETYL-L-CARNITINE
2 g acetylcarnitine taken orally twice a day.
Placebo Comparator: placebo Drug: placebo
placebo twice per day


Ages Eligible for Study:   40 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All

Inclusion Criteria:

  • 1) Chronic hepatitis with spontaneous manifest HE (mental state grade 1 or 2 according to the West Haven criteria) and an NCT-A performance time >30 seconds;
  • 2) Hyperammonemia (venous ammonia concentration >50 mmol/L);
  • 3) Cooperative, hospitalised, adult patients with liver cirrhosis diagnosed by clinical, histological and ultrasonographic findings (reduced dimensions of the liver as well as splenomegaly) and oesophageal varices at stage II and III observed by endoscopy.

Exclusion Criteria:

  • 1) Major complications of portal hypertension, such as gastrointestinal blood loss, hepatorenal syndrome or bacterial peritonitis;
  • 2) Acute superimposed liver injury;
  • 3) Patient with other neurological disease and metabolic disorders, diabetes mellitus, unbalanced heart failure and/or respiratory failure or end-stage renal disease;
  • 4) Alcoholic -toxic cirrhosis because toxic brain damage may interfere with the assessment of HE;
  • 5) Severe HE;
  • 6) Administration of anti-HE medications such as neomycin, branched-chain amino acids;
  • 7) Any additional precipitating factors such as high protein intake (additional high-protein meals), constipation or intake of psycho stimulants, sedatives, antidepressants, benzodiazepines, or benzodiazepines-antagonists (flumazenil), beta-adrenergic blockers, neuromuscular blocking agents, certain antibiotics;
  • 8) Patients with fever, sepsis or shock were also excluded to avoid variations caused by body temperature;
  • 9) Illiteracy.
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Please refer to this study by its identifier: NCT01223742

Cannizzaro Hospital
Catania, Italy, 95126
Sponsors and Collaborators
University of Catania
  More Information

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT01223742     History of Changes
Other Study ID Numbers: 8-12-00 B
Study First Received: October 18, 2010
Last Updated: October 18, 2010

Additional relevant MeSH terms:
Brain Diseases
Hepatic Encephalopathy
Signs and Symptoms
Central Nervous System Diseases
Nervous System Diseases
Liver Failure
Hepatic Insufficiency
Liver Diseases
Digestive System Diseases
Brain Diseases, Metabolic
Metabolic Diseases
Vitamin B Complex
Growth Substances
Physiological Effects of Drugs
Nootropic Agents processed this record on April 28, 2017