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Coenzyme Q10 and Meclofenoxate in Hepatic Encephalopathy (EH)

Primary Purpose

Hepatic Encephalopathy, Coenzyme Q10, Intellectual Functioning Disability

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Coenzyme Q10
MECLOFENOXATE
Sponsored by
Zagazig University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatic Encephalopathy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Amr Shaaban HanafyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

case group

control group

Arm Description

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

patients with liver cirrhosis and frequent hepatic encephalopathy received usual hepatic support only

Outcomes

Primary Outcome Measures

hepatic encephalopathy
Change in the number of episodes
health related quality of life
health related quality of life questionnaire
hepatic detoxifying function
reduction of serum ammonia

Secondary Outcome Measures

Full Information

First Posted
May 21, 2019
Last Updated
July 15, 2019
Sponsor
Zagazig University
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1. Study Identification

Unique Protocol Identification Number
NCT03961087
Brief Title
Coenzyme Q10 and Meclofenoxate in Hepatic Encephalopathy
Acronym
EH
Official Title
Impact of Coenzyme Q10 and Meclofenoxate on Frequency and Severity of Hepatic Encephalopathy
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Unknown status
Study Start Date
May 23, 2019 (Actual)
Primary Completion Date
January 1, 2020 (Anticipated)
Study Completion Date
February 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zagazig University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatic Encephalopathy, Coenzyme Q10, Intellectual Functioning Disability

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
patients with liver cirrhosis and frequent hepatic encephalopathy (HE)
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
case group
Arm Type
Active Comparator
Arm Description
patients with liver cirrhosis and frequent hepatic encephalopathy received coenzyme Q10 and Meclofenoxate in addition to usual hepatic support
Arm Title
control group
Arm Type
No Intervention
Arm Description
patients with liver cirrhosis and frequent hepatic encephalopathy received usual hepatic support only
Intervention Type
Drug
Intervention Name(s)
Coenzyme Q10
Other Intervention Name(s)
coQ10
Intervention Description
Coenzyme Q10 will be given twice
Intervention Type
Drug
Intervention Name(s)
MECLOFENOXATE
Other Intervention Name(s)
LUCIDREL
Intervention Description
MECLOFENOXATE will be given as 500 mg once daily.
Primary Outcome Measure Information:
Title
hepatic encephalopathy
Description
Change in the number of episodes
Time Frame
6 months
Title
health related quality of life
Description
health related quality of life questionnaire
Time Frame
6 months
Title
hepatic detoxifying function
Description
reduction of serum ammonia
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amr S Hanafy, M.D.
Phone
+201100061861
Email
DR_AMR_HANAFY@YAHOO.COM
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amr S Hanafy, M.D
Organizational Affiliation
Assistant prof of medicine-Zagazig University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Amr Shaaban Hanafy
City
Zagazig
State/Province
Alsharkia
ZIP/Postal Code
44519
Country
Egypt
Individual Site Status
Recruiting

12. IPD Sharing Statement

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Coenzyme Q10 and Meclofenoxate in Hepatic Encephalopathy

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