Coenzyme Q10 and Meclofenoxate in Hepatic Encephalopathy

Study Overview
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Brief Summary
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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.

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

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

Conditions
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Hepatic Encephalopathy, Coenzyme Q10, Intellectual Functioning Disability

Intervention / Treatment
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* Drug: Coenzyme Q10
* Drug: MECLOFENOXATE


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: patients with liver cirrhosis and frequent hepatic encephalopathy (HE)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: case group<br>patients with liver cirrhosis and frequent hepatic encephalopathy received coenzyme Q10 and Meclofenoxate in addition to usual hepatic support | Drug: Coenzyme Q10<br>* Coenzyme Q10 will be given twice<br>* Other names: coQ10;Drug: MECLOFENOXATE<br>* MECLOFENOXATE will be given as 500 mg once daily.<br>* Other names: LUCIDREL;|
| No Intervention: control group<br>patients with liver cirrhosis and frequent hepatic encephalopathy received usual hepatic support only | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hepatic encephalopathy | Change in the number of episodes | 6 months | 
| health related quality of life | health related quality of life questionnaire | 6 months | 
| hepatic detoxifying function | reduction of serum ammonia | 6 months |