Effect of Ashwagandha Root Extract on Stress and Anxiety in Adults: A clinical study
The present study was carried out to investigate the efficacy and safety of the Ashwagandha Root Extract on Chronic Stress
Objective: To examine the effect of Ashwagandha Root Extract on Chronic Stress
This was a single-centered, prospective, double-blind, randomized, placebo-controlled trial, primarily to evaluate the efficacy of high-concentration full-spectrum Ashwagandha root extract in reducing stress and anxiety and in improving general well-being in adults under stress. A total of 64 subjects complaining of mental stress were enrolled in the study for a duration of 60 days.
Subjects were enrolled in the study if they met the following inclusion criteria: (1) of age between 18 and 54 years, (2) free of psychiatric conditions other than stress (3) have a score less than 15 on the World Health Organization-five (WHO-5) well-being index and a score of at least 14 on the Perceived Stress Scale (PSS) and (4) could read and write English. On the WHO-5 well-being index, lower scores correspond to higher levels of stress.
Subjects were excluded if they met any one of the following exclusion criteria: (1) they were suffering from any chronic physical, hormonal, or psychiatric illness, (2) they were using certain hormonal birth-control measures, (3) they were currently on any medication on a regular basis, (4) they were currently taking any herbal preparations or formulations containing Ashwagandha, ginseng, ginkgo Biloba, Brahmi or related herbs, (4) they were pregnant or lactating, (5) they had substance dependence (6) they had abnormal laboratory or ECG findings.
Statistical methods and analysis
A sample of 64 subjects was enrolled in the study. Three subjects were not compliant with the study protocol. For efficacy analysis, only the 61 subjects compliant with the protocol were included. For safety analysis, we considered all 64 subjects in the intent-to-treat population. This consisted of all those subjects who took at least one dose of either the treatment drug or the placebo.
Efficacy was evaluated based on both physiological and survey measures. For each measure, we computed the difference across the two groups on Day 0 and across the two groups on Day 60. We performed a t-test to assess the statistical significance of this difference. We also computed, within each group, the change in the measure over the 60 days, and measured the difference in these changes across the two groups. A t-test was used to assess the statistical significance of this difference. For robustness, we also used the Mann-Whitney test, which is a non-parametric test. All these assessments collectively allowed us to evaluate the effect of the drug on various dimensions of stress.
A total of 64 subjects (32 in each study group) were included in the study of which 41 (64%) were men, and 23 (36%) were women [Table 1]. After randomization, each group had 32 subjects. None of the enrolled subjects had any illness related to cardiovascular, respiratory, gastrointestinal, nervous, endocrine, urogenital systems, or allergy/skin-related disorders. One subject reported a history of depression; however, at the time of enrollment, he was free from psychiatric symptoms. The rest of the subjects were free from psychiatric illnesses. Two subjects from the Ashwagandha group and one subject from the placebo group were lost to follow-up. On Day 60, 61 subjects had completed the study.
Perceived stress scale The PSS is perhaps the most commonly used psychological scale for assessing self-perception on the level of stress in one's life. The scale consists of ten items, with each item measuring the frequency or extent to which a certain stress-signaling event occurs. For each item, the score ranges from 0 to 4, with a score of zero connoting the absence or non-incidence of the corresponding stress-signaling event. The PSS score is obtained by summing the score across all ten items. The score ranges from 0 to 40, with a score of zero reflecting the virtual absence of stress in one's life. Table 2 summarizes the data and the results from the key statistical significance tests. On completion of 60 days of treatment, there was only a 5.5% reduction in baseline PSS scores in the placebo group, compared to 44.0% in the Ashwagandha group. The difference in reduction in PSS scores between the two groups over the 60-day study period was highly statistically significant (P<0.0001).
Many psychometric scales do not lend themselves to ratio-scale interpretations and translation of increments or decrements to percentage changes. In contrast, all the psychometric scales used in this study are interpreted in the research literature as ratio-scaled. The crucial property of the scales used in this paper, which allows us to translate increments or decrements to percentage changes, is that the lowest score value is anchored to zero and corresponds to a state where there are virtually zero stress-signaling events. Therefore, each scale value can be interpreted as the absolute degree of self-assessed stress. This is consistent with the many research publications in the stress literature that use such scales.
The findings suggest that high-concentration full-spectrum Ashwagandha root extract improves an individual's resistance towards stress and thereby improves self-assessed quality of life. High-concentration full-spectrum Ashwagandha root extract can be used safely as an adaptogen in adults who are under stress.
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