Ashwagandha (<i>Withania somnifera (L.) Dunal</i>) for promoting recovery in long covid: protocol for a randomised placebo-controlled clinical trial (APRIL Trial)
Mallinson PAC, Joshi M, Mathpathi M, Perkins A, Clayton T, Shah AS, Mathur R, Birk N, Dhillon A, Lieber J, Beg SS, Hopkins L, Khan A, Allaham S, Kam VT, Sutaria S, R G, Rajagopala S, Bhamra A, Pillai GKG, Khunti K, Nesari T, Kinra S
BMJ open · 4 citas
Cómo se estudió
- Diseño
- Ensayo controlado aleatorizado (clasificado por nuestro filtro de IA)
- Estudiado en
- Personas
- Resultado principal
- Marcadores de salud y funcionamiento
Quién lo pagó
- Financiación
- Financiación independiente
- Gobierno
- World Health Organization
- Universidad u hospital
- University of Pittsburgh
- Universidad u hospital
- London School of Hygiene and Tropical Medicine
- Gobierno
- Ministry of AYUSH, Government of India
- Gobierno
- National Institute for Health and Care Research
- Universidad u hospital
- Royal Botanical Gardens, Kew
- Gobierno
- Ministry of Ayurveda, Yoga and Naturopathy, Unani, Siddha and Homoeopathy
- Gobierno
- National Medicinal Plants Board, Ministry of AYUSH, Government of India
- Universidad u hospital
- NIHR Leicester Biomedical Research Centre
- Subvenciones
- Ministry of AYUSH, Government of India (CD No. 190 dated 13/08/2021)
Según 9 financiadores declarados.
Publicación
- Publicado
- 2025-04-01 · BMJ Open · vol. 15 · número 4 · pág. e094526
- Editorial
- BMJ
- Citado
- 3 citas · más que el 91% de estudios similares · 3.4× el promedio de su campo
- Impacto
- Entre el 10 % más citado de su campo
- Referencias
- 34 trabajos
- Acceso
- Acceso abierto (revista) · CC-BY
- Áreas de investigación
- Phytochemicals and Medicinal Plants · Diverse Scientific Research Studies · Long-Term Effects of COVID-19
- Palabras clave
- Medicine, Withania somnifera, Placebo, Adverse effect, Clinical trial, Randomized controlled trial, Traditional medicine, Alternative medicine, Internal medicine, Pathology
- MeSH
- humans, withania, plant extracts, treatment outcome, phytotherapy, double-blind method, quality of life, adult, female, male, randomized controlled trials as topic, withanolides, covid-19, sars-cov-2, post-acute covid-19 syndrome, covid-19 drug treatment
23 autores
- Poppy Alice Carson Mallinson🇬🇧London School of Hygiene & Tropical Medicine
- Manisha Joshi🇬🇧London School of Hygiene & Tropical Medicine
- Mahesh Mathpathi🇬🇧London School of Hygiene & Tropical Medicine
- Alexander Perkins🇬🇧London School of Hygiene & Tropical Medicine
- Tim C. Clayton🇬🇧London School of Hygiene & Tropical Medicine
- Anoop S.V. Shah🇬🇧London School of Hygiene & Tropical Medicine
- Rohini Mathur🇬🇧Queen Mary University of London
- Nick W. Birk🇬🇧London School of Hygiene & Tropical Medicine
- Arandeep Dhillon🇬🇧London School of Hygiene & Tropical Medicine
- Judith Lieber🇬🇧London School of Hygiene & Tropical Medicine
- Sidra S Beg🇺🇸The University of Texas Health Science Center at Houston
- Lily Hopkins🇬🇧London School of Hygiene & Tropical Medicine
- Archie Khan🇬🇧London School of Hygiene & Tropical Medicine
- Shereen Allaham🇬🇧University College London
- Vanessa Tw Kam🇬🇧London School of Hygiene & Tropical Medicine
- Shailen Sutaria🇬🇧Queen Mary University of London; London School of Hygiene & Tropical Medicine
- Raihan Kamal Galib🇮🇳National Institute of Ayurveda; Ministry of AYUSH; All India Institute of Ayurveda, New Delhi
- S Rajagopala🇮🇳National Institute of Ayurveda; Ministry of AYUSH; All India Institute of Ayurveda, New Delhi
- Amarjeet Bhamra🇬🇧Parliament of United Kingdom
- Geetha Krishnan Gopalakrishna Pillai🇨🇭World Health Organization
- Kamlesh K. Khunti🇬🇧University of Leicester
- Tanuja Manoj Nesari🇮🇳National Institute of Ayurveda; Ministry of AYUSH; All India Institute of Ayurveda, New Delhi
- Sanjay Kinra🇬🇧London School of Hygiene & Tropical Medicine
Resumen
El texto original del estudio, en el idioma en que se publicó.
Background
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 (Withania somnifera (L.) Dunal) 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.
Methods
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.
Discussion
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.
Trial registration number
This trial was pre-registered on 15/08/2022: ISRCTN12368131.
Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial (CC BY).
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