scholarly journals A RANDOMIZED CLINICAL ENDPOINT STUDY TO EVALUATE THE SAFETY AND EFFICACY OF CLEARLIV TABLETS IN PATIENTS WITH ALCOHOLIC LIVER DISEASE

Author(s):  
Ramesh Kannan S ◽  
Sivaraman V ◽  
Mirunalini C ◽  
Sakthibalan M ◽  
Jayashree S ◽  
...  

Objective: The objective of this study was to evaluate and compare the hepatoprotective effect of clearliv tablets with silymarin in patients with alcoholic liver disease.Methods: This was a prospective, randomized, multicenter, open-label, parallel group interventional clinical endpoint study (Phase IIa). Patients attending general medicine outpatient department were screened for alcoholic liver disease using the serum biochemical liver function test and ultrasonogram abdomen and tested whether they satisfy the selection criteria, and 24 patients were then enrolled in the study. The study drug, namely clearliv tablets of Apex Laboratories Pvt. Ltd., was administered to Group A and tablet silymarin was administered to Group B from day 1 to day 56. Patients were reviewed once in 2 weeks. Liver function test was repeated, and patients were enquired of their well-being and any adverse events.Results: The demographic characters and body weight of the subjects showed no significant difference between the groups. There is a significant improvement (p<0.05) in the aspartate transaminase (AST), alanine transaminase (ALT), and total bilirubin (TB) levels on 28th and 56th days in both silymarin and clearliv groups. Of the 2 groups, there is higher significance of improvement in clearliv group (p<0.001), compared to silymarin group. Clearliv group started showing a significant reduction in AST and ALT levels in the first 14 days of the study period. On comparing the mean percentage reduction in the levels of AST (35.7% and 35%), ALT (26.7% and 24.3%), and TB (26.7% and 25%), it was found that clearliv is showing a better percentage of reduction of the above parameters compared to silymarin. There were reports of adverse effects such as loss of appetite and gastritis in both the groups.Conclusion: This clinical study proves that clearliv is functioning as a hepatoprotective drug. It is offering a better hepatoprotection compared to silymarin. Clearliv tablets can be indicated for the management of liver dysfunction, which occurs due to alcoholic liver damage. It may also be used in similar manner in cases of viral hepatitis, drug-induced liver damage, acute and chronic hepatitis.

Author(s):  
Ramesh Kannan S ◽  
Sivaraman V ◽  
Mirunalini C ◽  
Sakthibalan M ◽  
Jayashree S ◽  
...  

Objective: The objective of this study was to evaluate and compare the hepatoprotective effect of clearliv tablets with silymarin in patients with alcoholic liver disease.Methods: This was a prospective, randomized, multicenter, open-label, parallel group interventional clinical endpoint study (Phase IIa). Patients attending general medicine outpatient department were screened for alcoholic liver disease using the serum biochemical liver function test and ultrasonogram abdomen and tested whether they satisfy the selection criteria, and 24 patients were then enrolled in the study. The study drug, namely clearliv tablets of Apex Laboratories Pvt. Ltd., was administered to Group A and tablet silymarin was administered to Group B from day 1 to day 56. Patients were reviewed once in 2 weeks. Liver function test was repeated, and patients were enquired of their well-being and any adverse events.Results: The demographic characters and body weight of the subjects showed no significant difference between the groups. There is a significant improvement (p<0.05) in the aspartate transaminase (AST), alanine transaminase (ALT), and total bilirubin (TB) levels on 28th and 56th days in both silymarin and clearliv groups. Of the 2 groups, there is higher significance of improvement in clearliv group (p<0.001), compared to silymarin group. Clearliv group started showing a significant reduction in AST and ALT levels in the first 14 days of the study period. On comparing the mean percentage reduction in the levels of AST (35.7% and 35%), ALT (26.7% and 24.3%), and TB (26.7% and 25%), it was found that clearliv is showing a better percentage of reduction of the above parameters compared to silymarin. There were reports of adverse effects such as loss of appetite and gastritis in both the groups.Conclusion: This clinical study proves that clearliv is functioning as a hepatoprotective drug. It is offering a better hepatoprotection compared to silymarin. Clearliv tablets can be indicated for the management of liver dysfunction, which occurs due to alcoholic liver damage. It may also be used in similar manner in cases of viral hepatitis, drug-induced liver damage, acute and chronic hepatitis.


Author(s):  
Pradeep G ◽  
Vikram B ◽  
Sharma DVHS

Background: It is estimated that liver diseases are among the top ten killer diseases in India, causing deaths every year. Besides, there are those who suffered from chronic liver problems needing recurrent hospitalization and prolonged medical attention, which leaves them physically, mentally, emotionally and financially devastated. Methodology: The study included (n=80) various liver disease patients admitted to the General Medicine department and controls (n=20) subjects were having normal health within the age group of 30-55 years. Serum levels of bilirubin, Aspartate Transaminase, Alanine Amino Transferase, Alkaline Phosphatase and Gamma Glutamyl Transferase parameters were studied among the subjects suffering from cirrhosis, alcoholic liver disease, viral hepatitis, obstructive jaundice type of liver diseases. Result: The results of this study showed that the increase in serum levels of Bilirubin, AST, ALT, ALP and GGT in various types of liver diseases i.e Obstructive jaundice, Cirrhosis of the liver, Viral hepatitis, Alcoholic Liver disease when compared with controls. Conclusion: Biochemistry laboratory investigations i.e. Liver Function Test (LFT) are a simple, easy measure of tools which can early diagnose the various types of liver diseases. Keywords: Liver diseases; Liver Bio-markers;  Liver Function Test.


Author(s):  
Richa K Lath ◽  
Aniruddha Jibhkate

Background: alcoholism is one of the major socioeconomic as well as public health problem in India. The problem is occurring equally in urban as well as in rural India. This study was carried out in essence of liver damage in alcoholics and alteration in the biochemical enzymes in the serum with respect to liver damage. Method: 100 alcoholics and 100 non alcoholic patients were selected from the hospital OPD. Liver function test was performed in both the study group. Liver  enzymes ALT,AST,ALP and the total protein and albumin level were compared in  the study group and controls. Results: The results showed there is significant increase in the liver enzymes ALT,AST,ALP in the alcoholic patients as compared to normal individual and significant fall in concentration of the total protein and albumin level in the alcoholics. Keywords: Alcoholics, liver function test


Author(s):  
J. M. Hill ◽  
A. L. Leisewitz ◽  
A. Goddard

Uric acid was used as a test for liver disease before the advent of enzymology. Three old studies criticised uric acid as a test of liver function. Uric acid, as an end-product of purine metabolism in the liver, deserved re-evaluation as a liver function test. Serumtotal bile acids are widely accepted as the most reliable liver function test. This study compared the ability of serumuric acid concentration to assess liver function with that of serumpre-prandial bile acids in dogs. In addition, due to the renal excretion of uric acid the 2 assays were also compared in a renal disease group. Using a control group of healthy dogs, a group of dogs with congenital vascular liver disease, a group of dogs with non-vascular parenchymal liver diseases and a renal disease group, the ability of uric acid and pre-prandial bile acids was compared to detect reduced functional hepatic mass overall and in the vascular or parenchymal liver disease groups separately. Sensitivities, specificities and predictive value parameters were calculated for each test. The medians of uric acid concentration did not differ significantly between any of the groups, whereas pre-prandial bile acids medians were significantly higher in the liver disease groups compared with the normal and renal disease group of dogs. The sensitivity of uric acid in detecting liver disease overall was 65% while the specificity of uric acid in detecting liver disease overall was 59 %. The sensitivity and specificity of uric acid in detecting congenital vascular liver disease was 68%and 59 %, respectively. The sensitivity and specificity of uric acid in detecting parenchymal liver disease was 63%and 60 %, respectively. The overall positive and negative predictive values for uric acid in detecting liver disease were poor and the data in this study indicated uric acid to be an unreliable test of liver function. In dogs suffering from renal compromise serum uric acid concentrations may increase into the abnormal range due to its renal route of excretion.


2021 ◽  
Vol 2021 ◽  
pp. 1-3
Author(s):  
Prabin Khatri ◽  
Aryan Neupane ◽  
Suman Raj Sapkota ◽  
Bibhav Bashyal ◽  
Dipesh Sharma ◽  
...  

The liver function test (LFT) is a commonly performed test in clinical practice in order to assess well-being of the liver; however, derangement in liver enzymes, however, may not necessarily imply an underlying liver pathology. The standard liver function test measures alanine aminotransferase (ALT), aspartate aminotransferase (AST), alanine phosphatase (ALP), bilirubin levels (total, direct, and indirect), proteins (total protein and albumin), and PT-INR (prothrombin time and international normalized ratio). In addition to common causes, liver enzyme levels can also be elevated due to extrahepatic causes, such as muscular injury can elevate transaminases levels. Here in, we present a case of an asymptomatic healthy male who was doing vigorous exercise and presented with reports of elevated transaminase levels. During evaluation of the case, most of his reports came to be within normal range. Additionally, when reevaluated after discontinuation of vigorous exercise, 3 weeks later and then a month later, his liver enzyme levels were observed to be within normal range. Hence, we suspect that muscle damage-induced transaminitis might not have been considered in the differential diagnosis during the evaluation of a patient with raised transaminases levels and also suggest that it should be kept as a differential in the given scenario.


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