Drug Development and Therapeutics

ORIGINAL ARTICLE
Year
: 2017  |  Volume : 8  |  Issue : 1  |  Page : 6--12

Efficacy and safety of hepano tablet in liver disorder patients with abnormal liver function test: A randomized active controlled prospective clinical study


Satyendra Kumar1, Arun Gupta1, Meenakshi Revadekar2, Sagar More3, Abhay Kulkarni4, Sunil S Borkar5 
1 Medical Affairs and Clinical Research Division, Dabur Research and Development Centre, Ghaziabad, Uttar Pradesh, India
2 Department of Kayachikitsa, R. A. Podar Medical College (Ayu), Mumbai, Maharashtra, India
3 Department of Kayachikitsa, MAM's Sumatibhai Shah Ayurved Mahavidyalaya and Sane Guruji Aarogya Kendra, Pune, Maharashtra, India
4 Ayurveda Research Center, Ayurved Seva Sangh, Nashik, Maharashtra, India
5 Department of Kaychikitsa, Shri Gurudeo Ayurved College, Gurukunj Ashram, Amravati, Maharashtra, India

Correspondence Address:
Satyendra Kumar
Medical Affairs and Clinical Research Division, Dabur Research and Development Centre, Dabur India Limited, 22, Site IV, Sahibabad, Ghaziabad - 201 010, Uttar Pradesh
India

Objective: Hepano Tablet is an Ayurvedic herbal formulation studied in pre-clinical models for safety and hepatoprotective efficacy. The current study was a randomized, active controlled, multicentre, prospective clinical study that aimed to evaluate hepatoprotective efficacy and safety of Hepano Tablets. Materials and Methods: Male and female liver diseases patients (18-65 years) with abnormal liver function tests were randomized to receive two tablets twice daily orally of either Hepano or a marketed comparator for 8 weeks with follow up at day 7, 14, 28 & 56 during treatment period and thereafter at day 84. Results were assessed from baseline to end of treatment basis changes in liver function tests and improvement in clinical symptoms of icterus in both the groups. Safety was assessed at all the visits basis changes in laboratory parameters and adverse event reporting for all cases who took at least one dose of the study drug. Results: Hepano Tablet and marketed comparator showed significant improvement in Liver functions - Serum Aspartate transaminase (AST), Alanine transaminase (ALT) and Total, Direct and Indirect Bilirubin Levels and a significant reduction in clinical symptoms of icterus that was comparable at all the visits. Conclusion: Hepano Tablets can significantly improve Liver Function Tests and clinical symptoms in liver disease patients and could be consumed safely.


How to cite this article:
Kumar S, Gupta A, Revadekar M, More S, Kulkarni A, Borkar SS. Efficacy and safety of hepano tablet in liver disorder patients with abnormal liver function test: A randomized active controlled prospective clinical study.Drug Dev Ther 2017;8:6-12


How to cite this URL:
Kumar S, Gupta A, Revadekar M, More S, Kulkarni A, Borkar SS. Efficacy and safety of hepano tablet in liver disorder patients with abnormal liver function test: A randomized active controlled prospective clinical study. Drug Dev Ther [serial online] 2017 [cited 2019 Sep 22 ];8:6-12
Available from: http://www.ddtjournal.org/article.asp?issn=2394-6555;year=2017;volume=8;issue=1;spage=6;epage=12;aulast=Kumar;type=0