A Summary of the article on “Adaptogenic and Anxiolytic Effects of Ashwagandha Root Extract in Healthy Adults: A Double-blind, Randomized, Placebo-controlled Clinical Study”
Background
The article “Adaptogenic and Anxiolytic Effects of Ashwagandha Root Extract in Healthy Adults: A Double-blind, Randomized, Placebo-controlled Clinical Study” was published in December 2019 in Cureus by authors including Jaysing Salve, Sucheta Pate, Khokan Debnath, and Deepak Langade. The research addresses the widespread issue of stress, anxiety, and impeded sleep in modern life, conditions that detract from healthful living and act as precursors to various ailments. Ashwagandha (Withania somnifera), an adaptogenic herb central to Ayurvedic and Unani systems of medicine, has a long history of use for maintaining general wellbeing and improving vitality. Adaptogens function by improving the body’s response to stress and normalizing physiological processes, often by regulating homeostasis via the hypothalamic pituitary adrenal (HPA) axis and controlling mediators like cortisol.
This particular study was the first to investigate the dose-response of a high-concentration Ashwagandha root extract while comparing a low dose against the normally recommended dose. The study aimed to evaluate the extract’s effect on reducing stress and anxiety in adults.
Methods
The trial was an eight-week, prospective, double-blind, randomized, placebo-controlled study conducted in India. Sixty healthy adults, male and female aged 18–55, were enrolled and randomized if they had a baseline Perceived Stress Scale (PSS) score greater than or equal to 20. The participants were allocated in a 1:1:1 ratio to receive capsules containing either 125 mg of KSM-66 Ashwagandha root extract, 300 mg of the extract, or an identical placebo (starch), twice daily for eight weeks. This resulted in total daily doses of 250 mg/day or 600 mg/day of Ashwagandha extract. Fifty-eight participants completed the study.
Efficacy was evaluated using physiological and psychometric measures. Stress was assessed using the 10-item Perceived Stress Scale (PSS). Anxiety intensity was measured using the 14-item Hamilton-Anxiety (HAM-A) Rating Scale. Serum cortisol, recognized as the most widely used biomarker for assessing physiological stress, was measured from blood samples. Additionally, sleep quality was assessed using a seven-point scale.
Results
The study found that the treatment with aqueous Ashwagandha root extract was considerably effective compared to the placebo.
Stress Reduction (PSS and Cortisol): A significant reduction in PSS scores was observed in both the Ashwagandha 250 mg/day ($P < 0.05$) and 600 mg/day ($P < 0.001$) groups when compared to placebo. Similarly, serum cortisol levels reduced significantly in both the 250 mg/day ($P < 0.05$) and 600 mg/day ($P < 0.0001$) groups compared to the placebo. In both PSS and serum cortisol measures, Ashwagandha 600 mg/day was statistically more effective than the 250 mg/day dose.
Anxiety and Sleep Quality: Regarding anxiety, the Ashwagandha 600 mg/day group showed a statistically significant reduction in HAM-A scores compared to the placebo ($P < 0.0001$), while the 250 mg/day group did not show a statistically significant reduction compared to placebo. For sleep quality, both the 250 mg/day ($P < 0.05$) and 600 mg/day ($P < 0.001$) treatments demonstrated significant improvement compared to the placebo group, with the higher dose again proving more effective.
Conclusions
The researchers concluded that the eight weeks of supplementation with aqueous Ashwagandha root extract was associated with a significant reduction of stress levels and improved overall quality of life. Ashwagandha was well tolerated, with no adverse events reported by the participants. The findings suggest that the use of this herb as a supplement for stress and anxiety management could be an excellent alternative option.
References
Salve, J., Pate, S., Debnath, K., & Langade, D. (2019). Adaptogenic and Anxiolytic Effects of Ashwagandha Root Extract in Healthy Adults: A Double-blind, Randomized, Placebo-controlled Clinical Study. Cureus. https://doi.org/10.7759/cureus.6466
This post is based on Open Access research and is for informational purposes only.
