Rationale

COVID-19 continues to take its toll on health in the UK and globally. There are concerns around the disease’s long-term sequelae often referred to as “long COVID”, with symptoms including respiratory problems (chronic cough, shortness of breath, chest tightness), cognitive dysfunction, poor mental health, extreme fatigue and muscle weakness. Symptoms can last for 1-3 months (called “ongoing symptomatic COVID-19”), or longer in many cases (called “post-COVID-19 syndrome”), and are estimated to affect around 20% of COVID-19 survivors. Long COVID is understood to be a multi-system disease, similar to some other post-viral syndromes, although its pathophysiology is still poorly understood, and there is little evidence around its effective treatment or management.

‘Ashwagandha’ (Withania somnifera), a traditional herb in the Indian Ayurvedic system of medicine, has been used for centuries for promoting energy and vitality, reducing stress and boosting the immune system. Recently, a number of randomised placebo-controlled trials in humans have demonstrated its efficacy for reducing anxiety and stress, improving muscle strength and VO2 max, enhancing sleep quality and cognition, and reducing symptoms of fatigue in patients treated for chronic conditions. This evidence, combined with emerging literature on its pharmacological and immunomodulatory effects in vitro and in animals, suggest Ashwagandha as a potential therapeutic candidate for alleviating the long-term symptoms of COVID-19.

Aim

The aim of this study is to determine whether Ashwagandha can improve functional status, quality of life and symptoms in UK adults suffering from long-term symptoms of COVID-19.

Objectives

Primary – to determine the effectiveness of Ashwagandha tablets (3-month course) for improving functional status (measured by the Post-COVID-19 Functional Status Scale) among people experiencing ongoing symptoms of COVID-19.

Secondary – to determine the effectiveness of Ashwagandha tablets (3-month course) for improving quality of life, reported fatigue, breathlessness, pain, sleep quality, mental health, cognitive function, work status and other symptoms.

Who can take part

Adults (18 years or older) who have a current diagnosis of Long COVID, defined as per NICE guideline on Long COVID (NG188), meet the other clinical screening criteria (i.e., without severe psychiatric disorder, liver test abnormalities or active malignancy, not pregnant, etc), and who are willing and able to complete the study protocols (take trial medication daily for 3 months and complete monthly clinical monitoring and online or postal questionnaires).

Trial design

This is a randomised double-blind placebo-controlled trial. Interested individuals who have a diagnosis of Long COVID (and conform to all other eligibility criteria) will be randomised to take Ashwagandha or placebo for 3 months (delivered at home by post). Follow-up for functional status, quality of life and other self-reported outcomes will be by online or postal surveys (as per participant preference) conducted monthly. Follow-up for safety will be through clinical assessment by the study investigator’s clinical team, conducted monthly.

View our recruitment pathway flowchart.