Ayurveda for promoting recovery in long COVID

INTERVENTION: Trial design: Randomised double‐blind placebo‐controlled trial. Interested adults who are diagnosed with long COVID (defined as per NICE guidelines ‐ NG188) that affect and limit their everyday activities will be randomised to take Ashwagandha or placebo for 3 months (delivered at home by post). Participants will be recruited through participating GP practices based across the UK. Eligible participants will be approached by the participating GP's team and trial discussed in detail. Participant Information Sheet (PIS) will be emailed/posted to them or handed to them (if seen face‐to‐face) at least 1‐2 days before signing the informed consent form (ICF). Participants will be able to go through the PIS and ask questions and discuss the trial information with research staff, their family and friends before taking a decision. Participants will be able to sign the ICF online or a paper copy will be posted to them. All ICFs will be verified and stored safely in the Investigator Site File (ISF) by the recruiting GP sites. After signing ICF, participants will have a consultation with the recruiting doctor (study investigator) for clinical assessment and eligibility. This may be in‐person or by phone/video call. Participants will have a blood test to assess their liver function at screening. All WOCBP will have urine pregnancy done before taking trial medication to rule out pregnancy. All participants will follow contraception methods as described in the protocol. Once the participant is confirmed eligible, the trial team will formally enrol them into the study and baseline questionnaires will be sent out. On receiving completed baseline questionnaires, participants will be randomised in the trial. CONDITION: Long COVID ; Infections and Infestations PRIMARY OUTCOME: Self‐reported functional status measured using the Post‐COVID‐19 Functional Status Scale (PCFS), at 3 months SECONDARY OUTCOME: ; Measured at baseline, 1 month, 2 months and 3 months; 1. Quality of life by PROMIS 29+2 summary score; 2. Self‐reported fatigue, pain, sleep, anxiety, depression and social, physical and cognitive function by PROMIS 29+2 individual dimensions; 3. Self‐reported breathlessness by modified MRC Dyspnoea Scale; 4. Health utility by EQ 5D‐5L utility score; 5. Self‐reported work status and productivity; 6. Other self‐reported symptoms; 7. Number of adverse events (3 months); INCLUSION CRITERIA: 1. Adults (18 years or older) with the capacity to provide informed consent, and 2. Have been diagnosed with Long COVID as per the NICE Guidelines (NG188) – that is, either one of “Ongoing symptomatic COVID‐19; signs and symptoms of COVID‐19 from 4 weeks up to 12 weeks”, or “Post‐COVID‐19 syndrome; Signs and symptoms that develop during or after an infection consistent with COVID‐19, continue for more than 12 weeks and are not explained by an alternative diagnosis. It usually presents with clusters of symptoms, often overlapping, which can fluctuate and change over time and can affect any system in the body. Post‐COVID‐19 syndrome may be considered before 12 weeks while the possibility of an alternative underlying disease is also being assessed”. The diagnosis will be confirmed by the participant’s GP and/or 3. medical records. 4. Report that their Long COVID has reduced their ability to carry out day‐to‐day activities compared with the