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Coenzyme Q10 and Meclofenoxate in Hepatic Encephalopathy (EH)
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Hepatic Encephalopathy Coenzyme Q10 Intellectual Functioning Disability | Drug: Coenzyme Q10 Drug: MECLOFENOXATE | Not Applicable |
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 (Clinical Trial) |
| Estimated Enrollment : | 300 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | patients with liver cirrhosis and frequent hepatic encephalopathy (HE) |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Impact of Coenzyme Q10 and Meclofenoxate on Frequency and Severity of Hepatic Encephalopathy |
| Actual Study Start Date : | May 23, 2019 |
| Estimated Primary Completion Date : | January 1, 2020 |
| Estimated Study Completion Date : | February 1, 2020 |
| 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 Name: coQ10
Drug: MECLOFENOXATE MECLOFENOXATE will be given as 500 mg once daily.
Other Name: LUCIDREL
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No Intervention: control group
patients with liver cirrhosis and frequent hepatic encephalopathy received usual hepatic support only
|
- hepatic encephalopathy [ Time Frame: 6 months ]Change in the number of episodes
- health related quality of life [ Time Frame: 6 months ]health related quality of life questionnaire
- hepatic detoxifying function [ Time Frame: 6 months ]reduction of serum ammonia
| Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
| Contact: Amr S Hanafy, M.D. | +201100061861 | DR_AMR_HANAFY@YAHOO.COM |
| Egypt | |
| Amr Shaaban Hanafy | Recruiting |
| Zagazig, Alsharkia, Egypt, 44519 | |
| Principal Investigator: | Amr S Hanafy, M.D | Assistant prof of medicine-Zagazig University |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | May 21, 2019 | ||||
| First Posted Date ICMJE | May 23, 2019 | ||||
| Last Update Posted Date | July 18, 2019 | ||||
| Actual Study Start Date ICMJE | May 23, 2019 | ||||
| Estimated Primary Completion Date | January 1, 2020 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE |
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| Change History | |||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Coenzyme Q10 and Meclofenoxate in Hepatic Encephalopathy | ||||
| Official Title ICMJE | Impact of Coenzyme Q10 and Meclofenoxate on Frequency and Severity of Hepatic Encephalopathy | ||||
| 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Not Applicable | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: patients with liver cirrhosis and frequent hepatic encephalopathy (HE) Masking: None (Open Label)Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE |
300 | ||||
| Original Estimated Enrollment ICMJE | Same as current | ||||
| Estimated Study Completion Date ICMJE | February 1, 2020 | ||||
| Estimated Primary Completion Date | January 1, 2020 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years to 70 Years (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers ICMJE | No | ||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | Egypt | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT03961087 | ||||
| Other Study ID Numbers ICMJE | 5501 | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE | Not Provided | ||||
| Responsible Party | Amr Shaaban Hanafy, Zagazig University | ||||
| Study Sponsor ICMJE | Zagazig University | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| PRS Account | Zagazig University | ||||
| Verification Date | July 2019 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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