Efficacy of Sildenafil in the Improvement of Cognition and Quality of Life in Patients With Cirrhosis of Liver. A Proof of Concept Study.
Hepatic Encephalopathy.
About this trial
This is an interventional treatment trial for Hepatic Encephalopathy. focused on measuring Minimal Hepatic Encephalopathy (MHE), Psychometric Hepatic Encephalopathy Score (PHES), Sickness Impact Profile (SIP), Model for End-stage Liver Disease (MELD), Child-Turcotte-Pugh score (CTP)
Eligibility Criteria
Inclusion Criteria: • Male patients aged 18-70 years diagnosed to have cirrhosis of liver at Liver Clinic of Department of Hepatology, PGIMER Chandigarh by means of clinical, biochemical and ultrasonographical/CT or liver biopsy.
- MHE will be defined by PHES ≤-5 and normal MMSE score of ≥24.
Exclusion Criteria:
- Patients unable to give informed consent.
- H/O alcohol intake during last 12 weeks.
- Significant comorbid illness such as heart disease, respiratory disease, or renal failure.
- Any neurological disease such as Alzheimer disease, Parkinson's disease, stroke, non- hepatic metabolic encephalopathy's.
- Any anatomical deformities or disease of the penis such as Peyronie's disease.
- Patients having psychiatric illness and taking treatment with antidepressant, sedative or neuroleptics.
- Patients who start taking alcohol during the study period will be excluded.
- Patients taking vasodilators such as nitrates.
- Hepatocellular carcinoma.
- Recent history of upper GI bleed in last 6 weeks.
- Active ongoing infection.
- Electrolyte abnormality precipitating MHE.
- Color vision abnormalities.
Sites / Locations
- Postgraduate Institute of Medical Education & Research Chandigarh
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
Intervention 'Sildenafil'.
'No sildenafil'
MHE patient receiving Sildenafil. Intervention: Sildenafil Drug Dosage: 25 mg once a day for one week followed by 25 mg twice daily for two weeks then 25 mg thrice daily for one week.
Control Arm: MHE patients not receiving SIldenafil Intervention.Followed up for 4 weeks.