Evaluation of efficacy and safety of Liv.52 DS tablets in acute viral hepatitis:
A prospective, double-blind, randomized, placebo-controlled,
phase III clinical trial
Dr. Rajiv Baijal, M.D., D.N.B.1, Dr. Nikhil Patel, M.D.,2 and Dr. S. A. Kolhapure, M.D.3*
1Gastroenterologist, 2Research Associates, Department of Gastroenterology,
Jagjivanram Western Railway Hospital, Mumbai Central, Mumbai, India. 3Senior Medical Advisor, R&D Center, The Himalaya Drug Company, Bangalore, India
Liv.52 DS tablets in acute viral hepatitis
INTRODUCTION
Viral hepatitis (A, B, C, D, E and G) is a global public health problem, which is responsible for a major chunk of morbidity and mortality. Viral hepatitis occurs endemically and sporadically throughout the world, depending on the endemicity of infection. Based on the prevalence of infection, various regions of world have been classified into areas of high endemicity (8% and above - Africa, South East Asia, South America and Middle East), areas of intermediate endemicity (2% to 8% - Australia, USA and Western Europe) and areas of low endemicity (below 2% - Northern Europe and Japan).
Hepatitis A is an acute, but benign form of viral hepatitis and is the least serious (self-limiting) disease. Acute hepatitis B can range from subclinical disease to fulminant hepatic failure and individuals with chronic hepatitis B are at increased risk for the development of hepatocellular carcinoma. Despite the discovery of hepatitis C, a permissive cell culture system for propagating HCV has yet to be established and a non-primate animal model does not exist. As a result, the production of specific drugs against HCV has been impeded although excellent diagnostic methods have been developed. The HDV infection occurs only in the presence of hepatitis B infection (co-infection or super-infection). Hepatitis E virus is ET-NANBH, which is clinically indistinguishable from hepatitis A disease and the disease is usually is mild expect in pregnant women, who appear to be exceptionally susceptible to severe disease and excessive mortality. The HGV/GBV-C is a recently characterized flavivirus, that may cause acute and chronic hepatitis and the precise role of HGV/GBV-C in human disease is currently under investigation.
The primary goals for managing acute viral hepatitis are to provide adequate nutrition (with restricted protein and fat intake), to prevent further damage to the liver, and to prevent transmission of infection to others. Therefore, early renormalizations of hepatic functions with symptomatic and clinical recovery are the primary objectives in the clinical management of acute hepatitis. There are no established drugs for hepatitis A, hepatitis E and hepatitis G. However, the available treatment options for hepatitis B, hepatitis C and hepatitis D have various limitations, such as dependable clinical efficacy, associated adverse effects and affordability issues.
Liv.52 DS tablet is a polyherbal formulation, which have been used extensively in the management of HA. Each Liv.52 DS tablet contains powders of Capparis spinosa, Cichorium intybus, Solanum nigrum, Terminalia arjuna, Cassia occidentalis, Achillea millefolium, Tamarix gallica and Mandura bhasma. This study was planned to evaluate the efficacy and safety of Liv.52 DS tablets in acute viral hepatitis.
Viral hepatitis (A, B, C, D, E and G) is a global public health problem, which is responsible for a major chunk of morbidity and mortality. Viral hepatitis occurs endemically and sporadically throughout the world, depending on the endemicity of infection. Based on the prevalence of infection, various regions of world have been classified into areas of high endemicity (8% and above - Africa, South East Asia, South America and Middle East), areas of intermediate endemicity (2% to 8% - Australia, USA and Western Europe) and areas of low endemicity (below 2% - Northern Europe and Japan).
Hepatitis A is an acute, but benign form of viral hepatitis and is the least serious (self-limiting) disease. Acute hepatitis B can range from subclinical disease to fulminant hepatic failure and individuals with chronic hepatitis B are at increased risk for the development of hepatocellular carcinoma. Despite the discovery of hepatitis C, a permissive cell culture system for propagating HCV has yet to be established and a non-primate animal model does not exist. As a result, the production of specific drugs against HCV has been impeded although excellent diagnostic methods have been developed. The HDV infection occurs only in the presence of hepatitis B infection (co-infection or super-infection). Hepatitis E virus is ET-NANBH, which is clinically indistinguishable from hepatitis A disease and the disease is usually is mild expect in pregnant women, who appear to be exceptionally susceptible to severe disease and excessive mortality. The HGV/GBV-C is a recently characterized flavivirus, that may cause acute and chronic hepatitis and the precise role of HGV/GBV-C in human disease is currently under investigation.
The primary goals for managing acute viral hepatitis are to provide adequate nutrition (with restricted protein and fat intake), to prevent further damage to the liver, and to prevent transmission of infection to others. Therefore, early renormalizations of hepatic functions with symptomatic and clinical recovery are the primary objectives in the clinical management of acute hepatitis. There are no established drugs for hepatitis A, hepatitis E and hepatitis G. However, the available treatment options for hepatitis B, hepatitis C and hepatitis D have various limitations, such as dependable clinical efficacy, associated adverse effects and affordability issues.
Liv.52 DS tablet is a polyherbal formulation, which have been used extensively in the management of HA. Each Liv.52 DS tablet contains powders of Capparis spinosa, Cichorium intybus, Solanum nigrum, Terminalia arjuna, Cassia occidentalis, Achillea millefolium, Tamarix gallica and Mandura bhasma. This study was planned to evaluate the efficacy and safety of Liv.52 DS tablets in acute viral hepatitis.
Aim of study
The study was planned to evaluate the clinical efficacy, and short- and long-term safety of Liv.52 DS tablets in acute viral hepatitis.
Study design
This study was a prospective, double blind, randomized, placebo-controlled, phase III clinical trial conducted at Jagjivanram Western Railway Hospital, Mumbai, India, from February 2003 to February 2004, as per the Declaration of Helsinki, with strict adherence with the GCP ethical guidelines. The study protocol, case report forms, regulatory clearance documents, product related information and informed consent form (in Bengali and English) were submitted to the Institutional Ethics Committee, and were approved by the same.
MATERIALS AND METHODS
Inclusion criteria
A total of 50 patients with diagnosis of symptomatic acute viral hepatitis, and who were willing to give informed consent were included in the study.
Exclusion criteria
Pregnant women, patients with chronic hepatitis (more than 6 months), patients with malignant jaundice, patients with other causes for acute hepatitis (drug-induced), and those who were unwilling to give informed consent were excluded from the study.
Copyrights © 2009 healthyliver.co.uk