A blend of Sphaeranthus indicus flower head and Terminalia chebula fruit extracts reduces fatty liver and improves liver function in non-alcoholic, overweight adults

Authors

  • Vamsi Krishna Pothula Rajendra Krishna Institute of Medical Sciences Hospital, Nellore, Andhra Pradesh
  • Sridhar Kurapati Krishna Institute of Medical Sciences Hospital, Nellore, Andhra Pradesh
  • Sai Krishna Balineni Aditya Multi Speciality Hospital, Guntur, Andhra Pradesh
  • Naga Tejaswi Tejaswi Gogineni General Medicine Department, Aditya Multi Speciality Hospital, Guntur, Andhra Pradesh, India

DOI:

https://doi.org/10.31989/ffhd.v12i7.958

Abstract

Background: Excessive accumulation of fat in the liver is a common clinical presentation in non-alcoholic fatty liver disease (NAFLD). The increasing prevalence of NAFLD is a growing health problem worldwide. The major risk factors of NAFLD include obesity, hyperlipidemia, and insulin resistance.

Objective: The aim of the present randomized, double-blind, placebo-controlled clinical trial was to assess the efficacy and tolerability of an herbal composition CL16049F1 in reducing fatty liver conditions and improving liver function in non-alcoholic, overweight individuals. CL16049F1 is a patented© blend of Sphaeranthus indicus flower head and Terminalia chebula fruit extracts.

Materials and Methods: Ninety male and female subjects (age: 25-60 yrs., BMI: 23-29 kg/m2) with elevated Fatty Liver Index (FLI) between 31 and 59 were randomized into three groups (n=30). The participants received a daily dose of 300mg CL16049F1, 320 mg Silymarin, or a placebo over a period of 84 consecutive days. FLI was evaluated as the primary efficacy measure. The secondary efficacy measures included the liver enzymes, lipid profile, and oxidative stress markers in serum, A 36-Item Short-Form Health Survey (SF-36), and Gastrointestinal symptoms (GIS) score were also evaluated. The clinical biochemistry, hematology, urine, and vital signs were evaluated as safety measures. Adverse events were also monitored.

Results: Eighty-eight subjects completed the study. Post-trial, the FLI score of CL16049F1-supplemented subjects was reduced by 13.81% (p<0.05) and 16.08% (p<0.05), while the Silymarin supplemented group exhibited reductions of 7.50% (p<0.05) and 7.27% (p<0.05) as compared to baseline and placebo, respectively. CL16049F1 supplementation significantly improved the liver enzymes, lipid profile, and oxidative markers in serum. The changes in the secondary efficacy measures in these treatment groups are comparable. No major adverse events were observed.

Conclusion: CL16049F1 is a well-tolerated and effective herbal formulation to reduce fatty liver and improve liver function in non-alcoholic, overweight subjects.


Keywords: Non-alcoholic fatty liver disease, Fatty liver index, CL16049F1, hepatoprotective botanical formulation.

 

Downloads

Published

2022-07-18

Issue

Vol. 12 No. 7 (2022): July 2022

Section

Research Articles

License

Authors retain the copyright of their articles and grant the Functional Food Center (FFC) and its journals the right of first publication under the terms of the Creative Commons Attribution 4.0 International License.

This license permits unrestricted use, distribution, and reproduction in any medium, including commercial use, provided the original author(s) and source are properly credited. Authors may post and share their published work freely, provided that the original publication in this journal is acknowledged.

By submitting to this journal, authors confirm that their manuscripts are original, not under consideration elsewhere, and that they hold the necessary rights to grant this license. The Functional Food Center encourages open scientific exchange and allows derivative and extended works, provided attribution to the original publication is maintained.