This trial will study the effect of a polyherbal capsule in lowering the viral load of patients with chronic Hepatitis B infection and record the incidence of from Hepatitis B surface antigen elimination in 12 months
A placebo controlled randomised trial. 3 herbs that have proven effect on eliminating the virus and normalizing liver function will be given. Equally matched placebo (blinded) will be given randomly to patients. All parameters of hepatitis B infection will be compared between the randomized groups
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
80
Each capsule contains 3 herbs. Phyllanthus niruri, Boerhaavia diffusa, picrorhiza kurroa
Inactive compound that is similar looking as the intervention
Mazumdar Shaw Mutispeciality Hospital
Bangalore, Karnataka, India
RECRUITINGNumber of patients with change in mean Hepatitis B Virus (HBV) DNA by at least 2log10 units from baseline at end of treatment for those with HBV DNA ≥ 1000 IU/ml.
Time frame: 12 months
Number of patients with change in hepatitis B surface antigen titers from baseline for those with HBV DNA <1000 IU/ml
Time frame: 12 months
Number of patients with Incidence of seroconversion from Hepatitis B surface antigen to anti-Hepatitis B surface antibody
Time frame: 12 months
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