A Prospective, Randomized Double-Blind, Placebo-Controlled Study of Safety and Efficacy of a High-Concentration Full-Spectrum Extract of Ashwagandha Root in Reducing Stress and Anxiety in Adults

Abstract

Context:Stress is a state of mental or emotional strain or tension, which can lead to underperformance and adverse clinical conditions. Adaptogens are herbs that help in combating stress. Ayurvedic classical texts, animal studies and clinical studies describe Ashwagandha as a safe and effective adaptogen.Aims:The aim of the study was to evaluate the safety and efficacy of a high-concentration full-spectrum extract of Ashwagandha roots in reducing stress and anxiety and in improving the general well-being of adults who were under stress.Settings and Design:Single center, prospective, double-blind, randomized, placebo-controlled trial.Materials and Methods:A total of 64 subjects with a history of chronic stress were enrolled into the study after performing relevant clinical examinations and laboratory tests. These included a measurement of serum cortisol, and assessing their scores on standard stress-assessment questionnaires. They were randomized to either the placebo control group or the study drug treatment group, and were asked to take one capsule twice a day for a period of 60 days. In the study drug treatment group, each capsule contained 300 mg of high-concentration full-spectrum extract from the root of the Ashwagandha plant. During the treatment period (on Day 15, Day 30 and Day 45), a follow-up telephone call was made to all subjects to check for treatment compliance and to note any adverse reactions. Final safety and efficacy assessments were done on Day 60.Statistical Analysis:t-test, Mann-Whitney test.Results:The treatment group that was given the high-concentration full-spectrum Ashwagandha root extract exhibited a significant reduction (P<0.0001) in scores on all the stress-assessment scales on Day 60, relative to the placebo group. The serum cortisol levels were substantially reduced (P=0.0006) in the Ashwagandha group, relative to the placebo group. The adverse effects were mild in nature and were comparable in both the groups. No serious adverse events were reported.Conclusion:The findings of this study suggest that a high-concentration full-spectrum Ashwagandha root extract safely and effectively improves an individual's resistance towards stress and thereby improves self-assessed quality of life.

An Alternative Treatment for Anxiety: A Systematic Review of Human Trial Results Reported for the Ayurvedic Herb Ashwagandha (Withania somnifera)

“…Chandrasekhar et al 19 enrolled 64 participants in a 60-day clinical trial that compared 600 mg of WS per day with placebo. Significant differences were found for all outcome measures, including scores on the Perceived Stress Scale ( p < 0.0001), the General Health Questionnaire ( p < 0.0001), and levels of cortisol in the bloodstream ( p = 0.0006).…”

The Effects of Adaptogens on the Physical and Psychological Symptoms of Chronic Stress

“…The study demonstrated that KSM-66 Ashwagandha extract significantly decreased feelings of stress, depression, anxiety and significantly increased general well-being after 60 days based on three different extensively used sets of stress scales (p< 0.0001) (Chandrasekhar, Kapoor, & Anishetty, 2012). Also, there was a statistically significant decrease in serum cortisol levels after 60 days (p< 0.0006) (Chandrasekhar et al, 2012).…”

“…Also, there was a statistically significant decrease in serum cortisol levels after 60 days (p< 0.0006) (Chandrasekhar et al, 2012). There were a few reports of adverse effects in both the placebo and the treatment group such as nausea, constipation, and drowsiness.…”

“…There were a few reports of adverse effects in both the placebo and the treatment group such as nausea, constipation, and drowsiness. The KSM-66 Ashwagandha dosage was 600 mg standardized to at least 5% withanolides (Chandrasekhar et al, 2012).…”

Effects of an Adaptogen-Based Supplement on Stress Parameters in Healthy Volunteers

“…For example, the adaptogen ashwagandha (Withania) significantly reduced stress in adults and significantly decreased serum cortisol levels after 60 days of treatment [24]. The reason for the lack of an effect of the adaptogen/vitamin product on cortisol levels after 28 days of treatment is not known.…”