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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.
Indian J Psychol Med. 2012 Jul; 34(3):255-62.IJ

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.

Authors+Show Affiliations

Department of Neuropsychiatry and Geriatric Psychiatry, Asha Hospital, Hyderabad, Andhra Pradesh, India.No affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article

Language

eng

PubMed ID

23439798

Citation

Chandrasekhar, K, et al. "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." Indian Journal of Psychological Medicine, vol. 34, no. 3, 2012, pp. 255-62.
Chandrasekhar K, Kapoor J, Anishetty S. 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. Indian J Psychol Med. 2012;34(3):255-62.
Chandrasekhar, K., Kapoor, J., & Anishetty, S. (2012). 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. Indian Journal of Psychological Medicine, 34(3), 255-62. https://doi.org/10.4103/0253-7176.106022
Chandrasekhar K, Kapoor J, Anishetty S. 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. Indian J Psychol Med. 2012;34(3):255-62. PubMed PMID: 23439798.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Chandrasekhar,K, AU - Kapoor,Jyoti, AU - Anishetty,Sridhar, PY - 2013/2/27/entrez PY - 2013/2/27/pubmed PY - 2013/2/27/medline KW - Adaptogen KW - Withania somnifera KW - high-concentration full-spectrum Ashwagandha root extract KW - stress SP - 255 EP - 62 JF - Indian journal of psychological medicine JO - Indian J Psychol Med VL - 34 IS - 3 N2 - 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. SN - 0253-7176 UR - https://www.unboundmedicine.com/medline/citation/23439798/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_ L2 - https://www.ncbi.nlm.nih.gov/pmc/articles/pmid/23439798/ DB - PRIME DP - Unbound Medicine ER -
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