BERRY
Research type
Research Study
Full title
A randomised, single blinded study investigating the role of ‘Sambucol® Black Elderberry Original Liquid (Sambucus nigra) in the treatment, progression and reduction of symptoms in participants with Coronavirus 19
IRAS ID
282732
Contact name
Jessica Evans
Contact email
Sponsor organisation
East Kent Hospitals University NHS Foundation Trust
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
Research Summary
SARS-CoV-2 is a readily transmissible virus that has a wide ranging incubation period of 2-14 days. The symptoms include fever, cough and loss of taste and smell. Symptoms range from mild to severe.
Pre-existing potential drug therapies are under investigation, but so far few have demonstrated any benefit and only in patients with severe symptoms. There is a scarcity of other pre-existing drug treatments that change the outcomes/symptoms in non-hospitalised patients with COVID-19
Prophylaxis and prevention is currently dependent on social distancing and isolating with vaccines remaining in development, potentially not for mass use in the near future.
Sambucus extract has well documented anti-viral properties both in vitro and in clinical trials of influenza, it has a low side effect profile so may be effective in reducing duration of symptoms and progression to more severe disease in patients with mild/ moderate COVID19. Sambucol® Black Elderberry Original Liquid (Sambucus nigra) is sold as a food supplement in heath food shops and supermarkets, does not require a prescription and has no known side effects, meaning it would be a well-tolerated treatment in early disease in comparison with other potential medications
The study will be conducted at East Kent Hospitals. Potential participants with mild or moderate confirmed COVID19 infection will be identified from the drive-through hospital test centre and accident and emergency.
Following an eligibility check and consenting they would be randomised to placebo or Sambucol® Black Elderberry (Sambucus nigra) 15ml four times daily for 14 days which they will take at home. Telephone consultations with the research team and patient daily diaries will used to document symptoms on days 1,3,7,10,14 and a follow up on day 28.
Time to clinical improvement will be compared between the 2 groups.Summary of Results
The outbreak of the coronavirus SARS-CoV-2 (COVID-19) in China in 2019 rapidly progressed to pandemic status of global importance. SARS-CoV-2 (COVID-19) is a readily transmissible virus that has a wide-ranging incubation period of 2-14 days (US Centers for Disease Control and Prevention). The symptoms are often non-specific and include fever, cough, fatigue, diarrhoea and loss of sense of taste and smell. Clinical features range from mild to severe. Black Elderberry- Sambucus nigra extract has well documented anti-viral properties and has been successful in treating influenza viruses in patients. There is evidence that Sambucus nigra has antiviral action against coronavirus in laboratory experiments. The aim of this randomised control trial was to determine whether Sambucol(r) Black Elderberry Original Liquid (Sambucus nigra) is effective in reducing the severity of symptoms of COVID-19. Between January 2021 and March 2022, a total of 204 patents were recruited into the trial and randomised to either receive Sambucol(r) Black Elderberry Original Liquid or a placebo. The placebo looked and tasted the same as the Sambucol(r) Black Elderberry Original Liquid but contained no elderberry extract. The treatment (Sambucol(r) Black Elderberry Original Liquid or placebo) was taken at a dose of 15ml, 4 times a day. The Sambucol(r) Black Elderberry Original Liquid was well tolerated by people who took part in the study. There were no serious side effects. To find out if Sambucol(r) Black Elderberry Original Liquid reduced the severity of COVID-19 symptoms we asked participants to record 'how well they felt overall' (wellness score) and how severe their individual symptoms were at regular intervals for 28 days. At the time it was acknowledged that in most people symptoms lasted for 1-2 weeks, so we hypothesised that if Sambucol(r) Black Elderberry Original Liquid had an effect we would see this by Day 10. When compared to wellness scores at the start of the study, there was no statistical difference between those in the group that received Sambucol(r) Black Elderberry Original Liquid and those that received the placebo. There was also no difference in the groups after 28 days.
REC name
Wales REC 6
REC reference
20/WA/0282
Date of REC Opinion
20 Nov 2020
REC opinion
Further Information Favourable Opinion