Mishra Deo Nidhi, Kumar Manoj
Department of Internal Medicine, Nirmal Hospital, Jhansi, Uttar Pradesh, 284128, India.
Heliyon. 2024 Aug 29;10(17):e36885. doi: 10.1016/j.heliyon.2024.e36885. eCollection 2024 Sep 15.
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.
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).
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 < 0.0001). Morning serum cortisol levels decreased by 66 % in AE60 and 67 % in AE120, compared to a 2.22 % change in the placebo group (p < 0.0001). Testosterone levels increased by 22 % in AE60 and 33 % in AE120, compared to a 4 % increase in males in the placebo group (p < 0.0001). PSS scores decreased by 53 % in AE60 and 62 % in AE120, CGI-severity scores decreased by 72 % in AE60 and 68 % in AE120, and PGIC scores improved by 60 % in both AE60 and AE120 groups, all showing significant differences compared to the placebo group.
Ashwagandha extract with 35 % withanolide glycosides (Shoden) at 60 mg and 120 mg was significantly effective in reduced morning serum cortisol and increasing total testosterone. Therefore, it can be recommended for reducing high stress and anxiety.
The study was prospectively registered in Clinical Trial Registry, India with registration number CTRI/2022/04/042133 [Registered on: April 25, 2022].
本随机安慰剂对照研究考察了南非醉茄根和叶提取物60毫克（AE60）和120毫克（AE120）（含35%的醉茄内酯糖苷，商品名Shoden）对压力和焦虑水平较高的身体健康受试者的影响。研究假设是，含有较高醉茄内酯糖苷的低剂量提取物会降低皮质醇水平并提高睾酮水平，从而减轻压力和焦虑。
本平行组研究招募了60名受试者，分配比例为1:1:1（AE60:AE120:安慰剂），为期60天。符合《精神疾病诊断与统计手册》第四版广泛性焦虑症（GAD）标准、汉密尔顿焦虑量表（HAMA）评分>20且早晨血清皮质醇>25微克/分升的受试者被纳入研究。参与者没有抑郁症状，并使用蒙哥马利-阿斯伯格抑郁量表进行了筛查。主要结局指标是HAMA，次要指标是早晨血清皮质醇、睾酮、感知压力量表（PSS）、临床总体印象量表（CGI）和患者总体变化印象量表（PGIC）。
60天后，治疗组与安慰剂组之间观察到显著差异。AE60组和AE120组的HAMA评分均下降了59%，而安慰剂组仅略有增加，为0.83%（p<0.0001）。AE60组早晨血清皮质醇水平下降了66%，AE120组下降了67%，而安慰剂组变化了2.22%（p<0.0001）。AE60组睾酮水平升高了22%，AE120组升高了33%，而安慰剂组男性仅升高了4%（p<0.0001）。AE60组PSS评分下降了53%，AE120组下降了62%；AE60组CGI严重程度评分下降了72%，AE120组下降了68%；AE60组和AE120组的PGIC评分均提高了60%，与安慰剂组相比均显示出显著差异。
含有35%醉茄内酯糖苷（Shoden）的60毫克和120毫克南非醉茄提取物在降低早晨血清皮质醇和提高总睾酮水平方面具有显著效果。因此，推荐其用于减轻高度压力和焦虑。
该研究已在印度临床试验注册中心进行前瞻性注册，注册号为CTRI/2022/04/042133[注册日期：2022年4月25日]。
