Randomized controlled trial2023Open access

A standardized Ashwagandha root extract alleviates stress, anxiety, and improves quality of life in healthy adults by modulating stress hormones: Results from a randomized, double-blind, placebo-controlled study

Majeed M, Nagabhushanam K, Mundkur L

Medicine · 27 citations

Review labels

Funding not disclosed

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 (indexed by PubMed)
Studied in
People
Main outcome
Health markers and function

Who paid for it

Funding
Funding not disclosed

Publication

Published
2023-10-13 · Medicine (Baltimore) · vol. 102 · issue 41 · p. e35521
Publisher
Wolters Kluwer
Cited
44 citations · more than 99% of similar papers · 13.8× the field average
Impact
Top 10% most cited in its field
References
55 works
Access
Open access (journal) · CC-BY
Research areas
Phytochemicals and Medicinal Plants · Piperaceae Chemical and Biological Studies · Medicinal Plants and Neuroprotection
Keywords
Medicine, Placebo, Piperine, Anxiety, Pittsburgh Sleep Quality Index, Cambridge Neuropsychological Test Automated Battery, Randomized controlled trial, Internal medicine, Pharmacology, Psychiatry, Insomnia
MeSH
humans, serotonin, alkaloids, piperidines, hydrocortisone, plant extracts, double-blind method, anxiety, anxiety disorders, quality of life, adult, india, benzodioxoles, polyunsaturated alkamides, withanolides, covid-19

3 authors

From US

  • Muhammed A. MajeedSabin Vaccine Institute
  • Kalyanam NagabhushanamSabin Vaccine Institute
  • Lakshmi Mundkur · corresponding

Abstract

Background

The coronavirus disease-2019 (COVID-19) pandemic has resulted in a surge in stress, anxiety, and depression worldwide. Ashwagandha, an ayurvedic adaptogen has been traditionally used to manage stress, anxiety, and general well-being.

Objective

We assessed the effect of Ashwagandha root extract (ARE-500 mg) standardized for 2.5% withanolides as per USP protocol with piperine (5 mg of 95% piperine) once daily for 60 days (12.5 mg withanolides/day) to alleviate stress and anxiety in healthy individuals with mild to moderate symptoms.

Methods

A randomized, double-blind, placebo-controlled study was conducted for 60 days using ARE (n = 27) and placebo (n = 27) once daily at night at Narayana Institute of Cardiac Sciences, Bangalore, and Vijaya Super Specialty Hospital, Nellore, in India. The objectives of this study were to assess an improvement in perceived stress scale (PSS), generalized anxiety disorder (GAD-7), quality of life (QOL), cognitive scores in the Cambridge Neuropsychological Test Automated Battery (CANTAB), changes in salivary cortisol, urinary serotonin, dopamine, serum levels of nitric oxide (NO), glutathione (GSH) and malondialdehyde (MDA) from baseline to end of the study. Safety was evaluated by laboratory parameters, and by monitoring any incidence of adverse events.

Results

54 individuals were randomized and 50 of them completed the study. The PSS, GAD-7, and QOL scores improved significantly in all the participants taking ARE compared to the placebo. The CANTAB analysis revealed a significant improvement in multitasking, concentration, and decision taking time in ARE compared to placebo. ARE was also associated with a greater reduction in the morning salivary cortisol and an increase in urinary serotonin compared to placebo. Serum levels of NO, GSH, and MDA were not significantly different. Biochemical and hematological parameters remained in the normal range in all participants and ARE was well tolerated during the study.

Conclusion

The results of the study suggest that ARE with 2.5% withanolides can effectively improve stress and anxiety by reducing cortisol and increasing serotonin in healthy individuals with mild to moderate symptoms.

Abstract via Europe PMC. Copyright remains with the authors or publisher (CC BY).

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