Shoden promotes Relief from stress and anxiety: A randomized, double-blind, placebo-controlled study on healthy subjects with high stress levels

Autor: Deo Nidhi Mishra, Manoj Kumar
Jazyk: angličtina
Rok vydání: 2024
Předmět:
Zdroj: Heliyon, Vol 10, Iss 17, Pp e36885- (2024)
Druh dokumentu: article
ISSN: 2405-8440
DOI: 10.1016/j.heliyon.2024.e36885
Popis: Background: This randomized placebo-controlled study examined the effect of ashwagandha root and leaf extract 60 mg (AE60) and 120 mg (AE120) (35 % withanolide glycosides, Shoden) in physically healthy subjects with higher stress and anxiety. It is hypothesized that a low dose extract with higher withanolide glycosides would decrease cortisol and increase testosterone thereby reducing stress and anxiety. Methods: This parallel arm study recruited 60 subjects with an allocation ratio of 1:1:1 (AE60:AE120: placebo) for 60 days. Subjects who fulfilled the DSM –IV Criteria for generalized anxiety disorder (GAD) with a Hamilton Anxiety Rating Scale, HAMA score >20, and morning serum cortisol >25 mcg/dl were included in the study. The participants did not have depression symptoms and were screened using Montgomery-Asberg Depression Rating Scale. The primary outcome measure was HAMA and the secondary measures were morning serum cortisol, testosterone, perceived stress scale (PSS), clinical global impressions scale (CGI), and patient's global impression of change scale (PGIC). Results: After 60 days, significant differences were observed between the treatment groups and placebo. HAMA scores decreased by 59 % in both AE60 and AE120 groups compared to a negligible increase of 0.83 % in the placebo group (p
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