Evaluation of Efficacy and Safety of NRL/2019/Nl in Liver Disorder Patients with Abnormal Liver Function Test: A Randomized, Parallel Arm, Interventional, Prospective Clinical Study
Journal: International Journal of Science and Research (IJSR) (Vol.9, No. 10)Publication Date: 2020-10-05
Authors : Omkar Kulkarni; Anuj Agrawal; Priya Khare; Gayatri Ganu;
Page : 1300-1306
Keywords : Liver disorder; fatty liver; herbal; clinical trial;
Abstract
Aim: The present study is proposed to evaluate the efficacy and safety of NRL/2019/NL a nutraceutical product in patients with abnormal Liver Function Test (LFT). Settings and Design: This was a randomized, parallel arm, interventional, prospective clinical study with 100 subjects allocated in two groups i. e. NRL/2019/NL (Test) or Marketed Product Group in 1: 1 ratio. Methods and Material: Male and female subjects of age between 18 to 65 years of age with diagnosis of hepatic disorder with abnormal LFT were recruited and followed for 3 months with treatment. Laboratory testing, antioxidant enzyme levels and USG were performed on screening and day 90 of the study treatment. Change is these Laboratory parameters from baseline to 3 months were assessed. Results and conclusion: NRL/2019/NL is safe in management of liver disorder with abnormal liver function tests. NRL/2019/NL is significantly effective in normalizing elevated liver enzymes. NRL/2019/NL significantly improved antioxidant enzyme status like catalase and superoxide dismutase etc. It has resolved fatty liver and hepatomegaly evident in USG from baseline to day 90. NRL/2019/NL is significantly effective in improving symptoms of liver disorders such as abdominal pain, abdominal tenderness, nausea, vomiting, fatigue, jaundice and anorexia etc.
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