King George's Medical University, Chowk, Lucknow, 226003, Uttar Pradesh, India.
M V Hospital and Research Centre, 314/30 Mirza Mandi, Post Office, Chowk, Lucknow, 226003, Uttar Pradesh, India.
Complement Ther Med. 2021 Mar;57:102642. doi: 10.1016/j.ctim.2020.102642. Epub 2020 Dec 15.
Ashwagandha (Withania somnifera) is a well-established and reputed herb in Ayurvedic medicine. It has been used as a "Rasayana" (rejuvenator), nootropic, and as a powerful natural adaptogen. The herb extract is extensively used for general wellbeing and in specific ailments. However, only a few studies have investigated the safety and tolerability of Ashwagandha in humans. This study evaluated the safety of Ashwagandha root extract consumption in healthy adults.
In this randomized, double-blind, placebo-controlled, and parallel-group study, 80 healthy participants (40 males, 40 females) were randomized in a 1:1 ratio to receive either Ashwagandha 300 mg or a placebo of the same dosage, twice daily, orally for 8 weeks. The study was conducted at MV Hospital, and King George Medical University, Lucknow, India. The primary safety outcomes considered were laboratory assessment of hematological parameters, serum biochemistry analysis including hepatotoxicity evaluation, and thyroid function parameters. The secondary outcomes of this study were the clinical adverse events and the vital parameters. The within and between the groups' datasets were compared using the Wilcoxon signed-rank test and the Mann Whitney U test, respectively.
A detailed evaluation of the vital signs such as body weight, body temperature, pulse rate, respiratory rate, systolic and diastolic blood pressure, and Body Mass Index (BMI) were conducted for each participant at the baseline and the end of the study for treatment and placebo groups. Similarly, hematological and biochemical parameters were evaluated at the baseline and at the end of study. The outcome did not indicate any untoward effects in any of the treated volunteers. No statistically significant change or abnormality was observed in the considered parameters including thyroid hormonal profile in both the groups. No adverse events were reported by any of the participants in this study.
Ashwagandha is being consumed since time immemorial following the Ayurvedic medicine practices. Modern science requires evidence of the safety and efficacy of the Ashwagandha extract before mass consumption for various health issues and as a supplement. The present study revealed that the consumption of Ashwagandha root extract for 8 weeks was safe in both males and females volunteers. However, long term study and varying dosage ranges should be investigated in the future.
印度传统阿育吠陀医学中，南非醉茄（Withania somnifera）是一种备受推崇的草药。它被用作“Rasayana”（ rejuvenator ）、益智药和强大的天然适应原。这种草药提取物广泛用于整体健康和特定疾病。然而，只有少数研究调查了南非醉茄在人类中的安全性和耐受性。本研究评估了健康成年人食用南非醉茄根提取物的安全性。
在这项随机、双盲、安慰剂对照、平行组研究中，80 名健康参与者（40 名男性，40 名女性）按照 1:1 的比例随机分为两组，分别接受南非醉茄 300mg 或相同剂量的安慰剂，每日两次，口服，持续 8 周。该研究在印度勒克瑙的 MV 医院和乔治国王医学大学进行。主要安全性结局是评估血液学参数的实验室评估、血清生化分析，包括肝毒性评估和甲状腺功能参数。本研究的次要结局是临床不良事件和生命参数。使用 Wilcoxon 符号秩检验和 Mann-Whitney U 检验分别比较组内和组间数据集。
对每组参与者的生命体征（体重、体温、脉搏率、呼吸率、收缩压和舒张压以及体重指数（BMI））进行了详细评估，基线和研究结束时进行了治疗和安慰剂组。同样，在基线和研究结束时评估了血液学和生化参数。结果表明，在任何接受治疗的志愿者中均未发现不良影响。两组考虑的参数（包括甲状腺激素谱）均未观察到任何统计学显著变化或异常。本研究没有参与者报告任何不良事件。
自古以来，南非醉茄就一直按照阿育吠陀医学的实践进行消费。现代科学需要在大规模消费南非醉茄提取物治疗各种健康问题和作为补充之前，证明其安全性和有效性。本研究表明，男性和女性志愿者连续 8 周食用南非醉茄根提取物是安全的。然而，未来应进行长期研究和不同剂量范围的研究。
