Ayurveda for Promoting Recovery In Long COVID (APRIL Trial)
Research type
Research Study
Full title
Clinical trial of Ashwagandha for promoting recovery from COVID-19 in the UK
IRAS ID
293329
Contact name
Sanjay Kinra
Contact email
Sponsor organisation
London School of Hygiene and Tropical Medicine
Eudract number
2020-005789-33
Duration of Study in the UK
0 years, 11 months, 31 days
Research summary
This study is a double-blind randomised placebo-controlled trial aiming to evaluate the effectiveness of a Indian traditional herb, Ashwagandha, for promoting recovery in people experiencing on-going symptoms of COVID-19 (long COVID).
‘Ashwagandha’ (Withania somnifera) has been used for centuries as part of the traditional Indian Ayurvedic system of medicine for promoting energy and vitality, reducing stress and boosting the immune system. Recently, a number of small and medium randomised trials in humans have demonstrated its potential effectiveness for reducing a number the symptoms characteristic of long COVID. Ashwagandha has a well accepted safety profile as is available over the counter as a herbal supplement in the UK.
For this trial, we propose to recruit up to 2500 patients with long COVID and offer them the herbal supplement (or placebo) tablets to be taken daily for 3 months. After three months we will collect patient-reported data on functional status, quality of time, symptom burden, work status and adverse events.
The trial will be conducted remotely (by phone, email/web and/or post). It will be advertised online, followed by a recruitment phone call, written informed consent process, and postage of trial medication to participants. Follow-up data will be collected by monthly online or postal questionnaires.REC name
Wales REC 3
REC reference
22/WA/0004
Date of REC Opinion
20 Jan 2022
REC opinion
Unfavourable Opinion