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
Chandrasekhar K, Kapoor J, Anishetty S
Indian journal of psychological medicine · 195 citations
How it was studied
- Design
- Randomized controlled trial (classified by our AI screen)
- Studied in
- People
- Main outcome
- Health markers and function
Who paid for it
- Funding
- Independent funding
Based on full-text disclosure statement.
Publication
- Published
- 2012-07-01 · Indian J Psychol Med · vol. 34 · issue 3 · pp. 255–262
- Publisher
- SAGE Publishing
- Cited
- 353 citations · more than 95% of similar papers · 5.6× the field average
- Impact
- Top 10% most cited in its field
- References
- 13 works
- Access
- Open access (repository copy) · CC-BY-NC-SA
- Research areas
- Phytochemicals and Medicinal Plants · Multidisciplinary Research Papers Compilation · Medicinal Plants and Neuroprotection
- Keywords
- Placebo, Medicine, Anxiety, Adverse effect, Randomized controlled trial, Clinical trial, Double blind, Internal medicine, Psychiatry, Alternative medicine
3 authors
From IN
- K. ChandrasekharAsha Hospital
- Jyoti KapoorAsha Hospital
- Sridhar Anishetty
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.
Abstract via Europe PMC. Copyright remains with the authors or publisher (CC BY-NC-SA).
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