Published in IJCP FEBRUARY 2019
A Randomized Clinical End Point Study to Evaluate the Safety and Efficacy of Polyherbal Tablets in Patients with Alcoholic Liver Disease
February 11, 2019 | Ramesh Kannan S, Sivaraman V, Mrinalini C, Sakthibalan M, Jayashree S, Vanangamudi Ss, Nagarajan Km, Arther Paul C

Objective: To evaluate and compare the hepatoprotective effect of herbal tablets with silymarin in patients with alcoholic liver disease. Material and methods: This was a prospective, randomized, multicenter, open-label, parallel group, interventional clinical end point study (Phase IIa). Patients attending General Medicine outpatient department were screened for alcoholic liver disease by using the serum biochemical liver function test, ultrasonogram (USG) abdomen. Investigators tested whether they satisfied the selection criteria and 24 patients were then enrolled in the study. The study drug 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 was a significant improvement (p < 0.05) in the aspartate transaminase (AST), alanine transaminase (ALT) and total bilirubin (TB) levels on 28th day and 56th day in both silymarin and herbal tablet groups. Out of the two groups, there was higher significance of improvement in herbal tablet group (p < 0.001), compared to silymarin group. The herbal tablet group started showing a significant reduction in AST and ALT levels in the first 14 days of study period. On comparing the mean percentage reduction in the levels of AST (35.7% vs. 35%), ALT (26.7% vs. 24.3%) and TB (26.7% vs. 25%), it was found that the herbal tablets showed a better percentage of reduction of the above parameters compared to silymarin. There were reports of adverse effects like loss of appetite and gastritis in both the groups. Conclusion: This clinical study proves that the herbal tablets used functioned as a hepatoprotective drug. They offered better hepatoprotection compared to silymarin. These 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, as well as acute and chronic hepatitis.