Hepatic Encephalopathy. Clinical Trial
Official title:
To Study The Proof of Concept in The Improvement of Cognition and Quality of Life in Cirrhotic Patients With Minimal Hepatic Encephalopathy by Means of a Pharmacological Intervention With Sildenafil (A Phosphodiesterase-5 Inhibitor).
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.
| Status | Active, not recruiting |
| Enrollment | 50 |
| Est. completion date | January 2014 |
| Est. primary completion date | November 2013 |
| Accepts healthy volunteers | No |
| Gender | Male |
| Age group | 18 Years to 70 Years |
| Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| India | Postgraduate Institute of Medical Education & Research Chandigarh | Chandigarh |
| Lead Sponsor | Collaborator |
|---|---|
| Postgraduate Institute of Medical Education and Research |
India,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Cognition( PHES) | Improvement of impairment in cognition as assessed by PHES (Psychometric Hepatic Encephalopathy Score) in patients of MHE (Minimal hepatic Encephalopathy) by means of pharmacological intervention by sildenafil (a PDE-5 inhibitor) before and after treatment. | 4 weeks | Yes |
| Primary | QOL(SIP) | To study the impact of treatment with sildenafil administration on the improvement in health-related quality-of-life of patients as assessed by sickness impact profile (SIP) before and after treatment. | 4 weeks | Yes |
| Secondary | CTP and MELD score before and after treatment with Sildenafil. | To study the impact of treatment with sildenafil on CTP and MELD scores before and after treatment. | 4 weeks | Yes |
| Secondary | Blood Ammonia and Interleukin-6 levels before and after treatment with Sildenafil. | Blood Ammonia and Interleukin-6 levels before and after treatment. | 4 weeks | Yes |