Preprint / Version 1

A standardized combination of Terminalia chebula and Withania somnifera extracts enhances immune function in adults: a pilot randomized, double-blind, placebo-controlled clinical study

Authors

  • Durga Sadhupati Help Hospital, Governorpet, Vijayawada, Andhra Pradesh, India
  • Rambhakta Lakshmisudha Help Hospital, Governorpet, Vijayawada, Andhra Pradesh, India
  • Karthik Chakravarthy Latha Super Speciality Hospital, Suryaraopet, Vijayawada, Andhra Pradesh, India
  • Partha Naidana Department of Community Medicine, ASR Academy of Medical Sciences, Eluru, Andhra Pradesh, India

Keywords:

botanical supplement for immune function, cell-mediated immunity, humoral immunity, randomized clinical trial, Terminalia chebula, Withania somnifera

Abstract

The use of botanical medicine has been demonstrated as a potential strategy to manage or treat a variety of health issues. Terminalia chebula (Retz) fruit and Withania somnifera (L.) Dunal roots are important medicinal herbs described in Ayurveda and traditional therapy for diverse health benefits. Objective This pilot study aimed to evaluate the immune function-enhancing potential of a unique blend of T. chebula fruit and W. somnifera root extracts, LN20189, in healthy men and women. Methods Forty healthy volunteers (age: 35–60 years) were randomized into two groups receiving either LN20189 (500 mg per day) or a matched placebo over 28 consecutive days. The total T-cell population was the primary efficacy measure in this study. The secondary efficacy measures included counts of CD4, CD8, natural killer (NK) cells, serum levels of interleukin-2 (IL-2), interferon-gamma (IFN-γ), total immunoglobulin-G (IgG), and Immune Function Questionnaire (IFQ) scores. Safety parameter assessments were also conducted. Results Post-trial, in LN20189-supplemented subjects, T cells, CD4, NK cells count, and the CD4:CD8 ratio were increased by 9.32, 10.10, 19.91, and 17.43%, respectively, as compared to baseline. LN20189 supplementation increased serum IFN-γ and IgG levels by 14.57 and 27.09% from baseline and by 13.98 and 21.99%, compared to placebo, respectively. Also, the IFQ scores in the LN20189 group were 84.68% (vs. baseline) and 69.44% (vs. placebo) lower at the end of the trial. LN20189 improved the study volunteers’ cellular and humoral immune functions. Conclusion In summary, LN20189 supplementation was found tolerable and improved the key cellular and humoral factors of the immune system and helped improve immune function of the trial volunteers. Keywords: botanical supplement for immune function, cell-mediated immunity, humoral immunity, randomized clinical trial, Terminalia chebula, Withania somnifera

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