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

NCT02028429 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2014-01-07

No results posted yet for this study

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.

Conditions

  • Hepatic Encephalopathy.

Interventions

DRUG

Sildenafil.

Arm 1 :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.

Sponsors & Collaborators

  • Post Graduate Institute of Medical Education and Research, Chandigarh

    lead OTHER

Principal Investigators

  • Radha K Dhiman, MD, DM, FACG · PGIMER Chandigarh

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-07-31
Primary Completion
2013-11-30
Completion
2014-01-31

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02028429 on ClinicalTrials.gov