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

U

University of Catania

Status

Completed

Conditions

Hepatic Encephalopathy

Treatments

Dietary Supplement: ACETYL-L-CARNITINE
Drug: placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT01223742
8-12-00 B

Details and patient eligibility

About

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.

Sex

All

Ages

40 to 65 years old

Volunteers

No Healthy Volunteers

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.

Trial design

0 participants in 2 patient groups, including a placebo group

ACETYL-L-CARNITINE
Experimental group
Treatment:
Dietary Supplement: ACETYL-L-CARNITINE
placebo
Placebo Comparator group
Treatment:
Drug: placebo

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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