南非醉茄（Withania somnifera (L.) Dunal）用于预防2019冠状病毒病感染：一项针对印度医护人员的多中心随机羟氯喹对照临床试验。
Ashwagandha, Withania somnifera (L.) Dunal, for the prophylaxis against SARS-CoV-2 infection: A multicentric randomized hydroxychloroquine controlled clinical trial in Indian health care workers.
作者信息
Kulkarni-Munshi Renuka, Talmohite Deepti, More Anand, Chakravarty Jaya, Kamat Sandhya, Khobragade Akash, Reddy D Himanshu, Patel Manish, Kajaria Divya, Singh Raju, Kumari Sarita, Mishra Priyanka, Srivastava A K, Bhagat Vivek, Pandey Saurabh, Yadav Meena, Darnule Rahul, Bhat Shobha, Kansal Sangeeta, Munot Sonali, Kumbhar Dipti, Tripathi Raakhi, Gajbhiye Snehalata, Marathe Padmaja, Parvatkar Jaee, Shukla Dhaiwat, Panchal Prakashkumar, Shah Jui, Bhale Jayashree, Sattigeri Viswajanani, Amarsheda Ashish, Avhad Anil, Kshirsagar Nilima, Mondhe Dilip M, Chopra Arvind
机构信息
TN Medical College & BYL Nair Hospital, Mumbai, 400008, India.
Employees' State Insurance (ESI) Hospital & PGIMSR, Mumbai, 400101, India.
出版信息
J Ayurveda Integr Med. 2025 Jun 6;16(3):101135. doi: 10.1016/j.jaim.2025.101135.
BACKGROUND
The study was planned when, the hydroxychloroquine (HCQ) was the only prophylactic agent approved by health authorities in several countries and no prophylactic COVID-19 vaccine was available.
OBJECTIVE
The present study aimed to evaluate efficacy of Withania Somnifera (L.) Dunal (WS) as a chemoprophylactic and immunomodulatory agent against SARS-CoV-2 infection.
METHODS
In a 12 week, randomized, open label, parallel group, two arm, comparative, multicentric, controlled trial compared WS with hydroxychloroquine (HCQ) in health care workers (HCWs). Total 400 HCWs were randomized in 1:1 ratio to receive either oral WS (500 mg for 12 weeks) or HCQ 400 mg (for 7 weeks). The primary outcome was to establish equivalence between WS and HCQ for the proportion of participants contracting SARS-CoV-2 infection.
RESULTS
Seven participants contracted SARS-CoV-2 infection: 5 in WS arm and 2 in HCQ arm. The equivalence between WS and HCQ was established for the proportion difference of participants contracting SARS-CoV-2 infection for per-protocol (PP) (1.6%, 95% CI: -1.08%-4.33%) and in subgroup analysis (ITT, mIIT, non-vaccinated and seronegative). Notably, the immunomodulatory effect of WS stood scientifically validated by the statistically significant difference in cytokine levels (p < 0.0001) at 12 weeks compared to baseline for Tumor Necrosis Factor (TNF)-alpha, Interleukin (IL)-2, IL-10, IL-17 and Monocyte chemoattractant protein-1 (MCP-1). Gastrointestinal-related AEs were most frequent (53 in WS and 58 in HCQ). Headache and sneezing were observed only with HCQ. Participant global assessment showed excellent tolerability with both treatment arms.
CONCLUSION
WS was found equivalent to HCQ as a prophylactic against SARS-CoV-2 infection with no safety concern. WS is thus inferred to be an effective and safe Ayurvedic intervention for prophylaxis against SARS-CoV-2 infection, and also as an immunobooster.
背景
本研究在羟氯喹（HCQ）是几个国家卫生当局批准的唯一预防药物且尚无预防性COVID-19疫苗可用时进行规划。
目的
本研究旨在评估印度人参（Withania Somnifera (L.) Dunal，WS）作为一种化学预防和免疫调节药物对抗严重急性呼吸综合征冠状病毒2（SARS-CoV-2）感染的疗效。
方法
在一项为期12周的随机、开放标签、平行组、双臂、比较性、多中心对照试验中，将卫生保健工作者（HCW）中的WS与羟氯喹（HCQ）进行比较。总共400名HCW按1:1比例随机分组，分别接受口服WS（500毫克，持续12周）或HCQ 400毫克（持续7周）。主要结局是确定WS和HCQ在感染SARS-CoV-2的参与者比例方面的等效性。
结果
7名参与者感染了SARS-CoV-2：WS组5名，HCQ组2名。对于符合方案（PP）人群中感染SARS-CoV-2的参与者比例差异（1.6%，95%置信区间：-1.08%-4.33%）以及在亚组分析（意向性分析 [ITT]、改良意向性分析 [mIIT]、未接种疫苗和血清阴性者）中，WS和HCQ之间建立了等效性。值得注意的是，与基线相比，在第12周时肿瘤坏死因子（TNF）-α、白细胞介素（IL）-2、IL-10、IL-17和单核细胞趋化蛋白-1（MCP-1）的细胞因子水平存在统计学显著差异（p < 0.0001），科学验证了WS的免疫调节作用。胃肠道相关不良事件最为常见（WS组53例，HCQ组58例）。仅在HCQ组观察到头痛和打喷嚏。参与者整体评估显示两个治疗组的耐受性都很好。
结论
发现WS作为预防SARS-CoV-2感染的药物与HCQ等效，且无安全问题。因此推断WS是一种有效且安全的阿育吠陀干预措施，可用于预防SARS-CoV-2感染，也是一种免疫增强剂。
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