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

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

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

Durga Prasad Sadhupati et al. Food Nutr Res. .

Abstract

Background: 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: Terminalia chebula; Withania somnifera; botanical supplement for immune function; cell-mediated immunity; humoral immunity; randomized clinical trial.

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Conflict of interest statement

The authors declare that there is no conflict of interest. The authors have not received any funding or benefits from industry or elsewhere to conduct this study.

Figures

Fig. 1
Fig. 1

HPLC chromatogram of LN20189. A representative elution profile at 227 nm shows the peaks at 8.01, 15.08, 21.97, 26.16, 26.55, 27.50, 28.49, 28.77, and 33.54 min representing chebulagic acid, chebulinic acid, withanoside IV, withaferin A, withanoside V, 12-deoxy withastramonolide, withanolide A, withanone, and withanolide B respectively.

Fig. 2
Fig. 2

Trial flowchart. The Consolidated Standards of Reporting Trials (CONSORT) diagram presents the flow of the double-blind, placebo-controlled trial. IFQ = Immune Function Questionnaire.

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