Mallinson Poppy Alice Carson, Joshi Manisha, Mathpathi Mahesh, Perkins Alexander, Clayton Tim, Shah Anoop Sv, Mathur Rohini, Birk Nick, Dhillon Arandeep, Lieber Judith, Beg Sidra S, Hopkins Lily, Khan Archie, Allaham Shereen, Kam Vanessa Tw, Sutaria Shailen, R Galib, Rajagopala S, Bhamra Amarjeet, Pillai Geetha Krishnan G, Khunti Kamlesh, Nesari Tanuja, Kinra Sanjay
Department of Non-Communicable Disease Epidemiology, London School of Hygiene & Tropical Medicine, London, UK
Department of Non-Communicable Disease Epidemiology, London School of Hygiene & Tropical Medicine, London, UK.
BMJ Open. 2025 Apr 25;15(4):e094526. doi: 10.1136/bmjopen-2024-094526.
Long covid describes a syndrome of persistent symptoms following COVID-19 and is responsible for substantial healthcare and economic burden. Currently, no effective treatments have been established. Ashwagandha () is a medicinal herb traditionally used in India for its immune-strengthening and anti-inflammatory properties. Withanolides, a family of steroid-derived molecules unique to Ashwagandha, have been shown to modulate inflammatory pathways in animal models, and several small randomised trials in humans support its effectiveness for reducing symptoms that are also associated with long covid. Therefore, this study aims to assess whether Ashwagandha is effective and safe for improving functional status and reducing symptom burden in adults living with long covid.
A randomised double-blind placebo-controlled trial will be performed at participating general practice (GP) surgeries and long covid clinics across the UK. Individuals diagnosed with long covid will be screened for eligibility and then randomised 1:1 to take 1000 mg daily of Ashwagandha root extract tablets (standardised to <0.9% withanolides) or matching placebo tablets for 3 months (target, n = 2500). Monthly online surveys will be performed to collect patient-reported outcomes, and monthly safety monitoring, including liver function tests, will be conducted by clinical site teams. The primary outcome of the Post-COVID Functional Status Scale score at 3 months will be assessed by baseline-adjusted ordinal logistic regression, according to a pre-published statistical analysis plan. The secondary outcomes included validated quality of life and long covid symptom scales, work status and productivity and adverse events. The trial has been approved as a Clinical Trial of an Investigational Medicinal Produce by the Medicines and Healthcare Regulatory Authority and by the NHS Research Ethics Committee and Health Research Authority.
Treatments for long covid are urgently needed. This trial will robustly evaluate the safety and efficacy of a candidate treatment with a promising efficacy and safety profile. If found to be effective, the findings will likely influence treatment guidelines and improve health outcomes in those living with long covid.
This trial was pre-registered on 15/08/2022: ISRCTN12368131.
“长新冠”描述的是新冠病毒感染后持续存在症状的一种综合征，它给医疗保健和经济带来了沉重负担。目前，尚未确立有效的治疗方法。南非醉茄（）是一种传统上在印度使用的草药，因其具有增强免疫力和抗炎特性。南非醉茄独有的一类甾体衍生分子——睡茄内酯，已被证明在动物模型中可调节炎症途径，并且在人类中进行的几项小型随机试验支持其对减轻与“长新冠”相关症状的有效性。因此，本研究旨在评估南非醉茄对于改善“长新冠”成年患者的功能状态和减轻症状负担是否有效且安全。
将在英国各地参与研究的全科医疗（GP）诊所和“长新冠”诊所进行一项随机双盲安慰剂对照试验。对被诊断为“长新冠”的个体进行资格筛查，然后按1:1随机分组，每天服用1000毫克南非醉茄根提取物片（以睡茄内酯含量<0.9%为标准）或匹配的安慰剂片，持续3个月（目标样本量，n = 2500）。将每月进行在线调查以收集患者报告的结果，临床站点团队将每月进行包括肝功能测试在内的安全性监测。根据预先发表的统计分析计划，通过基线调整的有序逻辑回归评估3个月时的新冠后功能状态量表评分这一主要结局。次要结局包括经过验证的生活质量和“长新冠”症状量表、工作状态和生产力以及不良事件。该试验已获得药品和医疗产品监管局、英国国家医疗服务体系研究伦理委员会以及健康研究管理局批准，作为一种研究性药品的临床试验。
迫切需要针对“长新冠”的治疗方法。本试验将有力地评估一种具有前景的疗效和安全性的候选治疗方法的安全性和有效性。如果被证明有效，研究结果可能会影响治疗指南，并改善“长新冠”患者的健康结局。
本试验于2022年8月15日进行预注册：ISRCTN12368131。
