A randomized, double blind, standard controlled trial to compare safety and efficacy of two leading brands of Ashwagandha products in patients suffering from mental health related symptoms
DOI:
https://doi.org/10.18203/2320-6012.ijrms20240206Keywords:
Ashwagandha, Mental health, Anxiety, Stress, Pittsburg sleep quality indexAbstract
Background: Mental health related symptoms are common among the population. Current treatment exhibits serious adverse effects, delayed onset of action and low efficacy. Ashwagandha has a variety of beneficial effects in mental health disorders. We did a comparison of two Ashwagandha brands using a variety of scales for anxiety, depression, stress, and sleep quality.
Methods: The study was conducted in 80 patients suffering from mental health related symptoms. Test product used was: Herbochem +91 Ashwagandha 500 mg capsules and control used was: KSM 66 Ashwagandha 600 mg capsules.
Results: The reduction in the perceived stress scores and Hamilton depression scale scores at day 30/60 from day 0 was higher in the test group as compared with the control group. The reduction in the Beck’s anxiety inventory scores at day 30/60/90 from day 0 was higher in the test group as compared with the control group. The increase in the Pittsburgh sleep quality index scores at day 30/60 from day 0 was higher in the test group as compared with the control group. The reduction in the serum cortisol scores at day 30 from day 0 was higher in the test group as compared with the control group. Results showed that, the incidence of adverse events was same in both groups.
Conclusions: It is important to note that test product having 500 mg Ashwagandha, showed better efficacy as compared to control product having 100 mg more (600 mg) of Ashwagandha.
References
Mental Disorders. World Health Organization. 2022. Available at: https://www.who.int/news-room/fact-sheets/detail/mental-disorders. Accessed on 30 November 2023.
Dhyani A, Gaidhane A, Choudhari SG, Dave S, Choudhary S. Strengthening Response Toward Promoting Mental Health in India: A Narrative Review. Cureus. 2022;14(10):e30435.
India State-Level Disease Burden Initiative Mental Disorders Collaborators. The burden of mental disorders across the states of India: the Global Burden of Disease Study 1990-2017. Lancet Psychiatry. 2020;7(2):148-61.
Mental illness. Mayo Foundation for Medical Education and Research. 2023. Available at: https://www.mayoclinic.org/diseases-conditions/ mental-illness/symptoms-causes/syc-20374968. Accessed on 30 November 2023.
Ferguson J. SSRI antidepressant Medications: Adverse effects and tolerability. J Clin Psychiatry. 2001;3(1):22-7.
Leucht S. Delayed onset of drug effects. Encyclopedia Psychopharmacol. 2010;372-4.
Speers A, Cabey K, Soumyanath A, Wright K. Effects of Withania somnifera (Ashwagandha) on stress and the stress-related Nnuropsychiatric disorders anxiety, depression, and insomnia. Curr Neuropharmacol. 2021;19:1468-95.
Vaccarino AL, Evans KR, Sills TL, Kalali AH. Symptoms of anxiety in depression: assessment of item performance of the Hamilton Anxiety Rating Scale in patients with depression. Depress Anxiety. 2008;25(12):1006-13.
Trajković G, Starčević V, Latas M, Leštarević M, Ille T, Bukumirić Z, Marinković J. Reliability of the Hamilton Rating Scale for Depression: a meta-analysis over a period of 49 years. Psychiatry Res. 2011;189(1):1-9.
Paul S, Chakraborty S, Anand U, Dey S, Nandy S, Ghorai M, et al. Withania somnifera (L.) Dunal (Ashwagandha): A comprehensive review on ethnopharmacology, pharmacotherapeutics, biomedicinal and toxicological aspects. Biomed Pharmacother. 2021;143:112175.
Kuboyama T, Tohda C, Komatsu K. Effects of Ashwagandha (roots of Withania somnifera) on neurodegenerative diseases. Biol Pharm Bull. 2014;37(6):892-7.
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.
Lopresti A, Smith S, Malvi H, Kodgule R. An investigation into the stress-relieving and pharmacological actions of an ashwagandha (Withania somnifera) extract: A randomized, double-blind, placebo-controlled study. Medicine (Baltimore). 2019;98(37):e17186.