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Immunomodulatory Effect of Withania somnifera (Ashwagandha) Extract—A Randomized, Double-Blind, Placebo Controlled Trial with an Open Label Extension on Healthy Participants

1
Department of Cardiothoracic Surgery, Oklahoma Heart Institute, University of Oklahoma College of Medicine, Tulsa, OK 73104, USA
2
Department of General Medicine, PGH Hospital, Uttam Nagar, New Delhi 110059, India
3
Department of Pathology, Christian Medical College, Vellore 632004, India
4
College of Engineering and Natural Sciences, Tulsa University, Tulsa, OK 74107, USA
5
Department of Medicine, Texas Tech Health Science University, Lubbock, TX 79430, USA
*
Author to whom correspondence should be addressed.
Academic Editor: Arutselvan Natarajan
J. Clin. Med. 2021, 10(16), 3644; https://doi.org/10.3390/jcm10163644
Received: 15 July 2021 / Revised: 10 August 2021 / Accepted: 12 August 2021 / Published: 18 August 2021
(This article belongs to the Section Immunology)
The immunomodulatory effect of Withania somnifera (WS) extract was tested in healthy adults. In this randomized placebo-controlled double-blinded study, subjects were allocated either 60 mg WS extract or placebo. It consists of a blinded 30-day period and an open-label extension study of another 30 days with crossover of only placebo to test. After the 30-day blinded study period, the WS test group reported significant increase (p < 0.05) in Ig’s (IgA, IgM, IgG, IgG2, IgG3 and IgG4), Cytokines (IFN-γ, IL4), TBNK (CD45+, CD3+, CD4+, CD8+, CD19+, NK cells) whereas in the placebo group TBNK cells showed significant decrease (p < 0.05) and Ig’s and cytokines showed no change (p > 0.05). In the extension period on day 60, the subjects on placebo who were crossed over to the WS test group showed significant increase (p < 0.05) in Ig’s, cytokines and TBNK cells and the subjects who continued on the WS group showed a further significant improvement (p < 0.05) in Ig’s, cytokines and TBNK cells. There were no adverse events reported in the study. WS extract significantly improved the immune profile of healthy subjects by modulating the innate and adaptive immune systems. Boosting the immune system of people at risk of infection and during widespread infections can be targeted with WS extract. View Full-Text
Keywords: Withania somnifera; withanolide glycosides; immunomodulation; immunity; Th1–Th2 pathway Withania somnifera; withanolide glycosides; immunomodulation; immunity; Th1–Th2 pathway
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MDPI and ACS Style

Tharakan, A.; Shukla, H.; Benny, I.R.; Tharakan, M.; George, L.; Koshy, S. Immunomodulatory Effect of Withania somnifera (Ashwagandha) Extract—A Randomized, Double-Blind, Placebo Controlled Trial with an Open Label Extension on Healthy Participants. J. Clin. Med. 2021, 10, 3644. https://doi.org/10.3390/jcm10163644

AMA Style

Tharakan A, Shukla H, Benny IR, Tharakan M, George L, Koshy S. Immunomodulatory Effect of Withania somnifera (Ashwagandha) Extract—A Randomized, Double-Blind, Placebo Controlled Trial with an Open Label Extension on Healthy Participants. Journal of Clinical Medicine. 2021; 10(16):3644. https://doi.org/10.3390/jcm10163644

Chicago/Turabian Style

Tharakan, Ajit, Himanshu Shukla, Irin R. Benny, Matthan Tharakan, Lekha George, and Santhosh Koshy. 2021. "Immunomodulatory Effect of Withania somnifera (Ashwagandha) Extract—A Randomized, Double-Blind, Placebo Controlled Trial with an Open Label Extension on Healthy Participants" Journal of Clinical Medicine 10, no. 16: 3644. https://doi.org/10.3390/jcm10163644

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