Efficacy of Sildenafil in the Improvement of Cognition and Quality of Life in Patients With Cirrhosis of Liver. A Proof of Concept Study.

• Status: Unknown status
• Trial end date: 2014-01-01
• Target enrollment: 0
• Participant gender: Male

Summary

The study is being conducted to evaluate the efficacy of Sildenafil (a 5-phosphodiesterase inhibitor) as a means to improve the cognitive impairment encountered in patients of minimal hepatic encephalopathy (MHE) as proposed in different studies.

This study would also assess the role of improvement of cognition as a means of improvement in quality of life.The patients will receive Sildenafil or no treatment for 4 weeks.

This study may prove and provide important therapeutic strategy for cognition impairment in patients with MHE.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Postgraduate Institute of Medical Education and Research
• Treatments: Phosphodiesterase 5 Inhibitors; Sildenafil Citrate

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.