Open AccessA 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,
C Mirunalini,
M Sakthibalan,
S. Jayashree,
Vanangamudi Ss,
Nagarajan Km,
Arther Paul C
Publication year - 2019
Publication title -
asian journal of pharmaceutical and clinical research
Language(s) - English
Resource type - Journals
eISSN - 2455-3891
pISSN - 0974-2441
DOI - 10.22159/ajpcr.2019.v12i1.29921
Subject(s) - medicine , liver function , alanine transaminase , gastroenterology , aspartate transaminase , statistical significance , transaminase , clinical endpoint , liver function tests , alcoholic liver disease , adverse effect , bilirubin , liver disease , outpatient clinic , clinical trial , alkaline phosphatase , cirrhosis , biochemistry , chemistry , enzyme
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.