Patients of cirrhosis aged 18 to 75 years who have no esophageal varices will be enrolled. After baseline evaluation, the participants will be randomized to receive either Placebo or Carvedilol 12.5 mg BD. After randomization they will be followed up for one year.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
132
Carvedilol will be administered orally at a start dose of 3.125 mg twice daily. After 1 week, this will increased if systolic blood pressure does not fall below 90 mm Hg. The patient will receive the maximum tolerated dose of carvedilol with a maximum of 6.25 BD.
The placebo tablets will be identical to the carvedilol tablets. First the patients will receive placebo in the dose of 1 BD. Then depending on his tolerance it will be increased to a maximum of 2 BD.
Institute of Liver & Biliary Sciences (ILBS)
New Delhi, National Capital Territory of Delhi, India
RECRUITINGthe proportions of patients who develop esophageal varices at 1 year in each group.
Time frame: 1 year
Number of patient dying in a period of one year
Time frame: 1 year
Number of patients needing discontinuation of therapy due to adverse effects.
Time frame: 1 year
Reduction in Hepatic Venous Pressure Gradient in both groups
Time frame: 1 year
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