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临床试验/NCT03961087
NCT03961087Unknown不适用

Impact of Coenzyme Q10 and Meclofenoxate on Frequency and Severity of Hepatic Encephalopathy

Zagazig University1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2019年5月23日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
300
试验地点
1
主要终点
hepatic encephalopathy

研究概览

简要总结

Hepatic encephalopathy is a syndrome occurs in patients with liver cirrhosis and is defined as neuropsychiatric abnormalities in patients with liver impairment, characterized by personality changes, intellectual impairment, and an impaired level of consciousness.

Coenzyme Q10 (CoQ10) is a necessary cofactor of the mitochondrial metabolism. It provides a High antioxidant and protective effects on age-related morbidities such as hypertension, heart failure and neurodegenerative diseases and hepatoprotective effects in drug related hepatic impairment.

Meclofenoxate is a cholinergic nootropic drug used clinically to improve memory, mental function and general cognition.

详细描述

Hepatic encephalopathy is a syndrome occurs in patients with liver cirrhosis and is defined as neuropsychiatric abnormalities in patients with liver impairment, characterized by personality changes, intellectual impairment, and an impaired level of consciousness. Hepatic encephalopathy is categorized into Type A hepatic encephalopathy associated with acute liver failure; Type B hepatic encephalopathy is associated with portal-systemic bypass and no intrinsic hepatocellular disease; Type C hepatic encephalopathy describes encephalopathy associated with Cirrhosis and portal hypertension; type C hepatic encephalopathy is, in turn, subcategorized as episodic, persistent, or minimal.

A number of theories had been postulated, it was proposed that hepatic encephalopathy is a disorder of astrocyte function which play a key role in the regulation of the blood-brain barrier, maintaining electrolyte homeostasis , a role in the detoxification of chemicals, including ammonia.

neurotoxic substances, including ammonia and manganese cause morphologic changes in the astrocytes leading to Alzheimer type II astrocytosis in cirrhosis.

Hepatic encephalopathy may be due to accumulated neurotoxic substances in the brain as short-chain fatty acids; mercaptans; false neurotransmitters, such as tyramine, octopamine, and beta-phenylethanolamines; manganese; ammonia; and gamma-aminobutyric acid (GABA).

Coenzyme Q10 (CoQ10) is a necessary cofactor of the mitochondrial metabolism. It provides a High antioxidant and protective effects on age-related morbidities such as hypertension, heart failure and neurodegenerative diseases and hepatoprotective effects in drug related hepatic impairment.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All the patients diagnosed as having liver cirrhosis Exclusion Criteria
  • recent alcohol intake;
  • Infection, recent antibiotic use or gastrointestinal bleeding;
  • use of drugs affecting psychometric Performances like benzodiazepines, antiepileptics, psychotropic drugs
  • History of shunt surgery or transjugular intrahepatic portosystemic shunt for portal hypertension;
  • Electrolyte abnormalities
  • Renal impairment or hepatorenal syndrome
  • hepatocellular carcinoma;
  • Severe medical co-morbidities that affect quality-of-life measurement as heart failure pulmonary or neurological insults.

排除标准

  • 未提供

研究组 & 干预措施

case group

Active Comparator

patients with liver cirrhosis and frequent hepatic encephalopathy received coenzyme Q10 and Meclofenoxate in addition to usual hepatic support

干预措施: Coenzyme Q10 (Drug)

case group

Active Comparator

patients with liver cirrhosis and frequent hepatic encephalopathy received coenzyme Q10 and Meclofenoxate in addition to usual hepatic support

干预措施: MECLOFENOXATE (Drug)

结局指标

主要结局

hepatic encephalopathy

时间窗: 6 months

Change in the number of episodes

hepatic detoxifying function

时间窗: 6 months

reduction of serum ammonia

health related quality of life

时间窗: 6 months

health related quality of life questionnaire

次要结局

未报告次要终点

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Amr Shaaban Hanafy

Assistant professor

Zagazig University

研究点 (1)

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