Gopukumar Kumarpillai, Thanawala Shefali, Somepalli Venkateswarlu, Rao T S Sathyanaryana, Thamatam Vijaya Bhaskar, Chauhan Sanjaya
Bengaluru Neuro Centre, Bengaluru, Karnataka 560003, India.
Inventia Healthcare Ltd., Mumbai, Maharashtra 400069, India.
Evid Based Complement Alternat Med. 2021 Nov 30;2021:8254344. doi: 10.1155/2021/8254344. eCollection 2021.
The global prevalence of stress is increasing. Stress adversely affects cognitive ability, sleep quality, and overall psychological well-being. Ashwagandha ( (L.) Dunal), an essential medicine in Ayurveda, is reportedly beneficial in reducing stress and improving memory. This double-blind, randomized, placebo-controlled clinical study evaluated the effect of Ashwagandha root extract sustained-release capsule 300 mg (Prolanza™; hereafter Ashwagandha SR) on cognitive functions, stress levels, sleep quality, overall well-being, and safety in stressed subjects.
Subjects (130 healthy cognitively sound adults [20-55 years, body mass index:18-29 kg/m]) having a Perceived Stress Scale (PSS) score of 14-24 were randomized to receive either Ashwagandha SR or placebo. Subjects took one capsule of Ashwagandha SR or placebo daily for 90 consecutive days. This study was registered on Clinical Trials Registry-India (CTRI) on 13/11/2019 [number: CTRI/2019/11/021990]. The primary endpoint was the change in cognitive function as measured by CANTAB from baseline to the end of the study period (90 ± 7 days). The secondary outcomes included the change in PSS-10 score, serum cortisol level (9-11 am), the OHQ score, the PSQI, and serum BDNF levels.
Only 125 completed the study and were evaluated. The Cambridge Neuropsychological Test Automated Battery (CANTAB) reported significantly improved recall memory, and the total error rate in recalling patterns significantly decreased at visit 4 in the Ashwagandha SR group vs. the placebo group (first attempt memory score:12.9 ± 6.7 vs. 10.1 ± 6.3; total errors:17.5 ± 23.3 vs. 27.7 ± 23.6). At visit 4, lower PSS-10 score (13.0 ± 5.0 vs. 18.7 ± 4.6; < .0001), serum cortisol levels (=0.0443), and Pittsburgh Sleep Quality Index (PSQI) score ( < .0001) but higher Oxford Happiness Questionnaire (OHQ) scores ( < .0001) were seen in Ashwagandha SR vs. the placebo group, suggesting significantly lower stress levels and significantly better psychological well-being and sleep quality in the former. No adverse events were reported.
This is the first clinical study assessing Ashwagandha SR for its safety and efficacy. Treatment with one Ashwagandha SR capsule once daily for 90 days improved memory and focus, psychological well-being, and sleep quality, reduced stress levels, and was safe and well-tolerated.
压力在全球的患病率正在上升。压力会对认知能力、睡眠质量和整体心理健康产生不利影响。印度草医学中的重要药物南非醉茄（Withania somnifera (L.) Dunal）据报道有助于减轻压力和改善记忆力。这项双盲、随机、安慰剂对照的临床研究评估了300毫克南非醉茄根提取物缓释胶囊（Prolanza™；以下简称南非醉茄SR）对压力大的受试者的认知功能、压力水平、睡眠质量、整体幸福感和安全性的影响。
将感知压力量表（PSS）得分在14 - 24之间的受试者（130名健康的认知健全成年人[20 - 55岁，体重指数：18 - 29 kg/m²]）随机分为接受南非醉茄SR或安慰剂组。受试者连续90天每天服用一粒南非醉茄SR胶囊或安慰剂。本研究于2019年11月13日在印度临床试验注册中心（CTRI）注册[编号：CTRI/2019/11/021990]。主要终点是通过剑桥神经心理测试自动成套系统（CANTAB）测量的从基线到研究期末（90±7天）认知功能的变化。次要结果包括PSS - 10得分、血清皮质醇水平（上午9 - 11点）、牛津幸福感问卷（OHQ）得分、匹兹堡睡眠质量指数（PSQI）以及血清脑源性神经营养因子（BDNF）水平的变化。
仅125名受试者完成研究并接受评估。剑桥神经心理测试自动成套系统（CANTAB）报告称，与安慰剂组相比，南非醉茄SR组在第4次访视时回忆记忆显著改善，回忆模式中的总错误率显著降低（首次尝试记忆得分：12.9±6.7对10.1±6.3；总错误数：17.5±23.3对27.7±23.6）。在第4次访视时，与安慰剂组相比，南非醉茄SR组的PSS - 10得分更低（13.0±5.0对18.7±4.6；P <.0001）、血清皮质醇水平更低（P = 0.0443）、匹兹堡睡眠质量指数（PSQI）得分更低（P <.0001），但牛津幸福感问卷（OHQ）得分更高（P <.0001），这表明前者的压力水平显著更低，心理健康和睡眠质量显著更好。未报告不良事件。
这是第一项评估南非醉茄SR安全性和有效性的临床研究。每天服用一粒南非醉茄SR胶囊，持续90天，可改善记忆力和注意力、心理健康和睡眠质量，降低压力水平，且安全且耐受性良好。
