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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Dr
Manisha
Joshi
+44 7510 382 984
manisha.joshi@lshtm.ac.uk
Dr
Poppy
Mallinson
+44 7510 382 984
poppy.mallinson1@lshtm.ac.uk
Prof
Sanjay
Kinra
+44(0)20 7927 2088
sanjay.kinra@lshtm.ac.uk
More information about this study, what is involved and how to take part can be found on the study website.
Long COVID
This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.
This study is a double-blind randomised placebo-controlled trial aiming to evaluate the effectiveness of an Indian traditional herb, Ashwagandha, for promoting recovery in people experiencing ongoing symptoms of 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 many of 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.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
You can take part if:
You may not be able to take part if:
1. Self-diagnosed Long COVID in the absence of a clinical diagnosis as per the NICE Guidelines2. Any medical condition or suspected medical condition which, in the opinion of the Investigator may present an unreasonable risk to the study participant as a result of his/her participation in this clinical study (this may involve conduct of any clinical assessment deemed necessary by the study investigator to confirm that this criterion is met, such as (but not limited to) validated psychiatric scales, ECGs, and laboratory tests for clinical chemistry, haematology, urinalysis, kidney function, etc).3. Previous clinical diagnosis of severe psychiatric disorders4. Abnormal liver function test results, as indicated by alanine aminotransferase or aspartate aminotransferase or total bilirubin >2 x ULN, either measured as part of routine care within past 3 months or conducted for the purposes of the clinical trial (if a recent test result is not available).5. Previous clinical diagnosis of chronic kidney disease or other medical condition associated with impaired kidney function6. Previous clinical diagnosis of heart disease or other cardiac problems7. Use of any investigational products within 5 elimination half-lives after the last dose or at screening8. History of malignancy unless resolved by adequate treatment with no evidence of recurrence9. Hypersensitivity to the active substance or to any of the excipients10. Women breastfeeding or with a positive urine pregnancy test at screening11. Women planning to become pregnant for the duration of the participation in the study12. Men and women of childbearing potential unwilling to adhere to the relevant contraception requirements for the duration of the study (until at least 24 hours after the final dose of trial medication is taken). Women of childbearing potential (WOCBP) are defined as all women who are: “fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy (HRT). However, in the absence of 12 months of amenorrhea, confirmation with more than one FSH measurement is required.” Acceptable contraception methods for WOCBP in this trial include: combined hormonal contraception, progestogen-only hormonal contraception, intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion, vasectomised partner, sexual abstinence, or condom use. Sexual abstinence is defined as: “refraining from heterosexual intercourse during the entire period of risk associated with the study treatments. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the subject”. Male participants are required to use condoms. All participants are required to inform investigator immediately if these contraception requirements are not met or if pregnancy is suspected.13. Participants taking benzodiazepines, anticonvulsants, barbiturates or any other CNS depressants
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
Dr
Manisha
Joshi
+44 7510 382 984
manisha.joshi@lshtm.ac.uk
Prof
Sanjay
Kinra
+44(0)20 7927 2088
sanjay.kinra@lshtm.ac.uk
Dr
Poppy
Mallinson
+44 7510 382 984
poppy.mallinson1@lshtm.ac.uk
More information about this study, what is involved and how to take part can be found on the study website.
The study is sponsored by London School of Hygiene & Tropical Medicine and funded by Ministry of AYUSH, Government of India (through the All India Institute of Ayurveda (AIIA), an autonomous institution under the Ministry of AYUSH).
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
You can print or share the study information with your GP/healthcare provider or contact the research team directly.
