NCT01223742已完成不适用
ORAL ACETYL-L-CARNITINE THERAPY REDUCES FATIGUE IN HEPATIC ENCEPHALOPATHY
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 试验地点
- 1
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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;
- •Hyperammonemia (venous ammonia concentration >50 mmol/L);
- •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.
排除标准
- •Major complications of portal hypertension, such as gastrointestinal blood loss, hepatorenal syndrome or bacterial peritonitis;
- •Acute superimposed liver injury;
- •Patient with other neurological disease and metabolic disorders, diabetes mellitus, unbalanced heart failure and/or respiratory failure or end-stage renal disease;
- •Alcoholic -toxic cirrhosis because toxic brain damage may interfere with the assessment of HE;
- •Severe HE;
- •Administration of anti-HE medications such as neomycin, branched-chain amino acids;
- •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;
- •Patients with fever, sepsis or shock were also excluded to avoid variations caused by body temperature;
- •Illiteracy.
研究组 & 干预措施
ACETYL-L-CARNITINE
Experimental
干预措施: ACETYL-L-CARNITINE (Dietary Supplement)
placebo
Placebo Comparator
干预措施: placebo (Drug)
研究者
研究点 (1)
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