Clinical Trial: To Compare the Efficacy and Safety of Carvedilol With or Without Simvastatin in Patients With Portal Hypertension and Esophageal Varices.
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: A Prospective Randomized Study to Compare the Efficacy and Safety of Carvedilol With or Without Simvastatin in Patients With Portal Hypertension and Esophageal Varices
Brief Summary: After successful screening of patients based on inclusion criteria, we will measure the baseline Hepatic Venous Pressure Gradient. At day 1 patients will undergo complete blood investigation including complete haemogram, kidney function test, liver function test, prothrombin time, AFP (Alfa Feto Protein) level, chest x ray, ultrasonography, fibroscan. Routine complete physical examination will be done.
Detailed Summary:
Sponsor: Institute of Liver and Biliary Sciences, India
Current Primary Outcome: Total number of patients who will be Responders. [ Time Frame: 3 Months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Total number of patients develop esophageal variceal bleed [ Time Frame: 3 months ]
- Total number of patients develop PHG (Portal Hypertensive Gastropathy). [ Time Frame: 3 months ]
- Total number of patients develop GAVE (Gastric Antral Vascular Ectasia). [ Time Frame: 3 months ]
- Total number of patients develop Gastric Varices. [ Time Frame: 3 months ]
- Total number of patients develop adverse Events of the study drug [ Time Frame: 3 months ]
- Improvement in the CTP (Child-Turcotte-Pugh score) score. [ Time Frame: 3 months ]
- Improvement in the MELD (Model for End Stage liver Disease) score. [ Time Frame: 3 months ]
Original Secondary Outcome: Same as current
Information By: Institute of Liver and Biliary Sciences, India
Dates:
Date Received: June 4, 2015
Date Started: June 2015
Date Completion: October 2017
Last Updated: March 6, 2017
Last Verified: January 2017
