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APRIL Trial - Ayurveda for Promoting Recovery In Long COVID

APRIL is a randomised, placebo-controlled trial of a traditional Indian herbal medicine for treating Long COVID, led by researchers at the London School of Hygiene & Tropical Medicine, UK, and the All-India Institute of Ayurveda, India.

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Ayurveda

Ayurveda is an ancient system of traditional medicine originating in the Indian subcontinent.

Ashwagandha (Withania somnifera) is an important medicinal herb in Ayurveda, believed to have anti-inflammatory and immuno-modulatory properties. Previous trials suggest it could help to relieve stress, anxiety and fatigue, and to improve sleep and physical performance. In this trial we are trying to see if Ashwagandha can improve functional status, quality of life and symptoms in adults suffering from Long COVID in the UK.

Trial participants

The trial is currently taking place across participating GP sites in the UK. Over the next year, we plan to recruit ~2500 adults (aged 18 and over) living in the UK who have been diagnosed with long COVID (as per the NHS Guidelines) by their doctor, and who find that this condition is affecting their ability to carry out their day-to-day activities. To enter the trial, individuals must be contacted by a participating GP site.

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 randomly allocated to take the traditional Indian herb, or placebo for 3 months (delivered at home by post). During this period, they will complete monthly questionnaires online (or by post), and monthly check-ins with their study doctor’s team. Neither the participant, nor the researchers, will know who is taking the herb or the placebo tablets, to avoid bias in the study results.

Team

The APRIL trial team consists of global experts in clinical trials research and Ayurvedic medicine, from the UK and India.

Trial design
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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.

Ayurveda and Ashwagandha
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Ayurveda, a natural system of medicine, originated in India over 5,000 years ago. The term Ayurveda is derived from the Sanskrit words ayur (life) and veda (science or knowledge). Thus, Ayurveda means knowledge of life. It is a holistic science considering the individual as a whole and seeks to re-establish harmony between all three the Mind, Body and Soul. It has two main principles; 1) prolong life and promote perfect health (by following diet and lifestyle practices including yoga and meditation to increase longevity with good physical and mental health) and 2) to eradicate the disease and dysfunction of the body. Thus, Ayurveda is a Health promotive, preventive, curative and nutritive science.

Ashwagandha (Withania somnifera), also known as Indian ginseng or winter cherry, is an evergreen shrub that grows in India, the Middle East, and parts of Africa. Roots of ashwagandha are used for medicinal purposes in Ayurveda. Ashwagandha is believed to be an ‘adaptogen’ which means it helps the body respond to stress as well as promoting overall strength and wellbeing. Its pharmacological mechanisms of action are thought to be related to the anti-inflammatory and immune-modulatory effects of certain metabolites found exclusively in this plant.

In this trial we are trying to see if Ashwagandha can improve functional status, quality of life and alleviate symptoms in UK adults suffering from long-term symptoms of COVID-19.

Who we are
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The APRIL trial team consists of global experts in clinical trials research and Ayurvedic medicine, from the UK and India.

LSHTM

Chief Investigator - Prof Sanjay Kinra

  • Professor of Clinical Epidemiology and Head of the Department of Non-Communicable Disease Epidemiology. 

Co-Investigators

  • Dr Anoop Shah MD PhD, Clinical Epidemiologist
  • Dr Poppy Mallinson, Epidemiologist
  • Dr Mahesh Mathpati, Research Fellow and Dr of Ayurvedic medicine
  • Tim Clayton, Medical statistician
  • Alexander Perkins, Research Fellow
  • Dr Rohini Mathur, Epidemiologist

Trial Manager

  • Dr Manisha Joshi, Dr of Ayurvedic medicine and Registered Clinical Research Practitioner.

All India Institute of Ayurveda

Lead Investigator - Prof Tanuja Nesari

  • Director of the All-India Institute of Ayurveda and MD (Ayurveda medicine).

Co-Investigators

  • Dr S Rajagopala, MD (Ayurveda medicine)
  • Dr Galib, MD (Ayurveda medicine)

Since inception the trial has been closely supported by:

WHO Complementary and Alternate Therapies

  • Dr G Geetha Krishnan, MD (Ayurveda medicine)

All-Party Parliamentary Group - Indian Traditional Sciences

  • Amarjeet S Bhamra, Secretariat

The research is conducted in collaboration with clinical site teams based at GP surgeries. Collaborating sites include:

Hockley Farm Medical Practice

  • Principal Investigator – Prof Kamlesh Khunti
Resources
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The APRIL Trial is currently looking for GP practices who wish to be involved in patient recruitment and clinical monitoring for this trial. For more information on how to join as a participating GP site, please do not hesitate to get in touch with the trial manager at APRIL@lshtm.ac.uk.

Further detail about what potential participants in the trial should expect, and some answers to common questions, are provided in the below documents.

Unfortunately, we cannot recruit patients into this trial except through one of the participating GP sites. If you are a patient interested to join the trial, please speak to your GP, rather than contact the Trial Team.