Immunomodulatory Effect of Withania somnifera (Ashwagandha) Extract-A Randomized, Double-Blind, Placebo Controlled Trial with an Open Label Extension on Healthy Participants
Tharakan A, Shukla H, Benny IR, Tharakan M, George L, Koshy S
Journal of clinical medicine · 38 citations
Review labels
Neutral facts our review recorded about how this study was done. They describe method, never whether we like the result.
How it was studied
- Design
- Randomized controlled trial (classified by our AI screen)
- Studied in
- People
- Main outcome
- Mechanisms only
Who paid for it
- Funding
- Funding not disclosed
Publication
- Published
- 2021-08-18 · J Clin Med · vol. 10 · issue 16 · p. 3644
- Publisher
- Multidisciplinary Digital Publishing Institute
- Cited
- 85 citations · more than 99% of similar papers · 11.6× the field average
- Impact
- Top 10% most cited in its field
- References
- 30 works
- Access
- Open access (journal) · CC-BY
- Research areas
- Phytochemicals and Medicinal Plants · Herbal Medicine Research Studies · Andrographolide Research and Applications
- Keywords
- Withania somnifera, Medicine, Placebo, Immune system, Crossover study, Adverse effect, Immunology, Internal medicine, Randomized controlled trial, CD8, Gastroenterology, Pathology
6 authors
From US, IN
- Ajit K. Tharakan · correspondingOklahoma Heart Institute; University of Oklahoma
- Himanshu Shukla
- Irin Rosanna BennyChristian Medical College, Vellore
- Matthan TharakanUniversity of Tulsa
- Lekha K. GeorgeTexas Tech University Health Sciences Center
- Santhosh K. G. KoshyTexas Tech University Health Sciences Center
Abstract
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 p 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 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.
Abstract via Europe PMC. Copyright remains with the authors or publisher (CC BY).
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