Randomized controlled trial2019Industry fundedOpen access

Funded in part by Arjuna Natural Extracts Ltd

An investigation into the stress-relieving and pharmacological actions of an ashwagandha (Withania somnifera) extract: A randomized, double-blind, placebo-controlled study

Lopresti AL, Smith SJ, Malvi H, Kodgule R

Medicine · 123 citations

Review labels

Author industry tiesIndustry funded

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
Industry funded
Company
Arjuna Natural Extracts Ltd
Authors
At least one author declares a financial tie to industry

Based on 1 listed funder(s) and full-text disclosure statement.

Publication

Published
2019-09-01 · Medicine (Baltimore) · vol. 98 · issue 37 · p. e17186
Publisher
Wolters Kluwer
Cited
235 citations · more than 100% of similar papers · 17.3× the field average
Impact
Top 10% most cited in its field
References
49 works
Access
Open access (journal) · CC-BY
Research areas
Phytochemicals and Medicinal Plants · Mindfulness and Compassion Interventions · Cardiac Health and Mental Health
Keywords
Withania somnifera, Medicine, Placebo, Anxiolytic, Anxiety, Testosterone (patch), Adverse effect, Randomized controlled trial, Rating scale, DASS, Internal medicine, Traditional medicine, Psychiatry, Psychology, Alternative medicine
MeSH
humans, dehydroepiandrosterone sulfate, testosterone, hydrocortisone, anti-anxiety agents, plant extracts, treatment outcome, phytotherapy, double-blind method, stress, psychological, anxiety, adult, female, male

4 authors

From AU, IN

  • Adrian L. Lopresti · correspondingMurdoch University
  • Stephen James SmithMurdoch University
  • Hakeemudin MalviBhopal Memorial Hospital & Research Centre
  • Rahul Kodgule

Abstract

Background

Ashwagandha (Withania somnifera (L.) Dunal) is a herb traditionally used to reduce stress and enhance wellbeing. The aim of this study was to investigate its anxiolytic effects on adults with self-reported high stress and to examine potential mechanisms associated with its therapeutic effects.

Methods

In this 60-day, randomized, double-blind, placebo-controlled study the stress-relieving and pharmacological activity of an ashwagandha extract was investigated in stressed, healthy adults. Sixty adults were randomly allocated to take either a placebo or 240 mg of a standardized ashwagandha extract (Shoden) once daily. Outcomes were measured using the Hamilton Anxiety Rating Scale (HAM-A), Depression, Anxiety, and Stress Scale -21 (DASS-21), and hormonal changes in cortisol, dehydroepiandrosterone-sulphate (DHEA-S), and testosterone.

Results

All participants completed the trial with no adverse events reported. In comparison with the placebo, ashwagandha supplementation was associated with a statistically significant reduction in the HAM-A (P = .040) and a near-significant reduction in the DASS-21 (P = .096). Ashwagandha intake was also associated with greater reductions in morning cortisol (P < .001), and DHEA-S (P = .004) compared with the placebo. Testosterone levels increased in males (P = .038) but not females (P = .989) over time, although this change was not statistically significant compared with the placebo (P = .158).

Conclusions

These findings suggest that ashwagandha's stress-relieving effects may occur via its moderating effect on the hypothalamus-pituitary-adrenal axis. However, further investigation utilizing larger sample sizes, diverse clinical and cultural populations, and varying treatment dosages are needed to substantiate these findings.

Trial registration

Clinical Trials Registry-India (CTRI registration number: CTRI/2017/08/009449; date of registration 22/08/2017).

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

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