Coenzyme Q10 and Meclofenoxate in Hepatic Encephalopathy (EH)

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

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.

Study Overview

• Status: Unknown
• Conditions: Hepatic Encephalopathy; Coenzyme Q10; Intellectual Functioning Disability
• Intervention / Treatment: Drug: Coenzyme Q10; Drug: MECLOFENOXATE

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Alsharkia
    • Zagazig, Alsharkia, Egypt, 44519
      • Recruiting
      • Amr Shaaban Hanafy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Zagazig University
• Investigators: Principal Investigator: Amr S Hanafy, M.D, Assistant prof of medicine-Zagazig University

Study record dates

Study Major Dates

• Study Start (Actual): May 23, 2019
• Primary Completion (Anticipated): January 1, 2020
• Study Completion (Anticipated): February 1, 2020

Study Registration Dates

• First Submitted: May 21, 2019
• First Submitted That Met QC Criteria: May 21, 2019
• First Posted (Actual): May 23, 2019

Study Record Updates

• Last Update Posted (Actual): July 18, 2019
• Last Update Submitted That Met QC Criteria: July 15, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Digestive System Diseases; Liver Failure; Hepatic Insufficiency; Metabolic Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Liver Diseases; Neurodevelopmental Disorders; Brain Diseases, Metabolic; Hepatic Encephalopathy; Brain Diseases; Intellectual Disability; Physiological Effects of Drugs; Neuroprotective Agents; Protective Agents; Micronutrients; Vitamins; Nootropic Agents; Coenzyme Q10; Ubiquinone; Meclofenoxate
• Other Study ID Numbers: 5501

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No