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Evidence-Based Supplement Research
Evidence-Based Supplement Research

Effects of Withania somnifera Extract in Chronically Stressed Adults: A Randomized Controlled Trial.

  • 2024-04-26
  • Nutrients 16(9)
    • Srikanta Pandit
    • Amit K Srivastav
    • Tapas K Sur
    • Supriyo Chaudhuri
    • Yan Wang
    • Tuhin K Biswas

Study Design

Type
Randomized Controlled Trial (RCT)
Sample size
n = 131
Population
131 adults with self-reported high stress
Methods
8-week, randomized, double-blinded, placebo-controlled study to compare the effects of three different WS extract doses (125, 250 and 500 mg)
Blinding
Double-blind
Duration
8 weeks
  • Large Human Trial
  • Rigorous Journal

Background

Stress is a known causative factor in modulating cognitive health, which overall well-being and quality of life are dependent on. Long-term stress has been shown to disrupt the balance of the hypothalamic-pituitary-adrenal (HPA) axis. Adaptogens, such as Withania somnifera (ashwagandha), are commonly used in Ayurvedic medicine for stress relief and ameliorating HPA-axis dysfunction. The aim of this study was to support the role of a root and leaf water-extracted ashwagandha extract (WS) in stress reduction by confirming the lowest clinically validated dose for stress management (125 mg/day) in a dose-dependent clinical study in adults with self-reported high stress.

Methods

An 8-week, randomized, double-blinded, placebo-controlled study to compare the effects of three different WS extract doses (125, 250 and 500 mg) was performed. A total of 131 adults were enrolled, and 98 were included in the final analysis. Attenuation of chronic stress was measured using the 14-item Perceived Stress Scale (PSS) and biochemical-related stress parameters.

Results

We have shown that aqueous WS extract (roots and leaves) safely reduces mild to moderate chronic stress at doses of 125 mg, 250 mg, and 500 mg/day for 8 weeks.

Conclusions

Our findings demonstrate the stress-reduction capabilities of this well-characterized aqueous extract of WS (root and leaf) at the low dose of 125 mg/day, in a dose-dependent manner, via the modulation of the HPA axis.

Trial registration

This study was registered with the Clinical Trials Registry-India (CTRI) with the registration number: CTRI/2019/11/022100.

Research Insights

  • We have shown that aqueous WS extract (roots and leaves) safely reduces mild to moderate chronic stress at doses of 125 mg, 250 mg, and 500 mg/day for 8 weeks.

    Effect
    Beneficial
    Effect size
    Small
    Dose
    125 mg, 250 mg, or 500 mg per day
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