HATRIC: a study of Pelargonium sidoides root extract EPs®7630 (Kaloba®) for the treatment of acute cough due to lower respiratory tract infection in adults—study protocol for a double blind, placebo-controlled randomised feasibility trial

Abstract

Background Acute lower respiratory tract infection is a common acute infection managed in primary care. The current dominant management strategy in the UK is antibiotics, despite widespread publicity regarding antimicrobial resistance and evidence that the small benefits of antibiotics do not outweigh the harms. There is a need to address the rising problem of antibiotic resistance by providing credible alternative strategies, which reduce symptom burden. There is sufficient evidence to recommend the use of Pelargonium sidoides root extract in order to warrant undertaking an independent clinical trial. We propose a feasibility study to demonstrate our ability to recruit and retain patients and conduct a placebo-controlled trial of Pelargonium sidoides extract EPs®7630 in lower respiratory tract infection where pneumonia is not suspected. Both the tablet and liquid formulations will be included. Methods The HATRIC trial is a double-blind randomised placebo-controlled feasibility study aiming to determine the potential to conduct a fully powered trial of Pelargonium sidoides root extract as an alternative to the inappropriate use of antibiotics for acute bronchitis in UK primary care. Primary care sites will be equally randomised to one of two formulation groups (tablet or liquid preparation). Additionally, within each site, patients will be evenly randomised to active or placebo treatment. Antibiotic consumption will be monitored during the trial, but the use of a delayed prescription strategy is encouraged. The target sample size for this study is 160 patients overall or 40 per arm, recruited from approximately 20 primary care sites. The analysis will be descriptive focusing on estimation with no formal comparison of groups taking place. Discussion If this trial demonstrates the feasibility of recruitment and delivery, we will seek funding for a fully powered placebo-controlled trial of Pelargonium sidoides root extract for the treatment of lower respiratory tract infections in primary care. Trial registration HATRIC was registered on the ISRCTN registry ( ISRCTN17672884 ) on 16 August 2018.

Therapeutic potential of medicinal plants against COVID-19: The role of antiviral medicinal metabolites

“…There is a whole list of herbs assessed for their activity against SARS-CoV viruses ( Table 2 ). Most notable among them are the Lycoris radiata (Li et al, 2005c) , Artemisia annua , Lindera aggregate , Isatis indigotica ( Lin et al, 2005 ) , Torreya nucifera ( Ryu et al, 2010 ), Houttuynia cordata ( Lau et al, 2008 ), Pelargonium sidoides ( Whitehead et al, 2019 ), and Glychirrhiza spp. ( Fiore et al, 2008 ).…”

“…It was also revealed through flow cytometry-based analysis that extracts of H. chordata boosted immune response against SARS-CoV through increasing the proportion of cluster of differentiation (CD4 + and CD8 + ) T cells. Similarly, root extract of P. sidoides has been shown to interfere with replication of human coronaviruses ( Whitehead et al, 2019 ). Currently, there are numerous studies available on plant-based compounds from limited number of plants against coronaviruses.…”

Pelargonium sidoides root extract for the treatment of acute cough due to lower respiratory tract infection in adults: a feasibility double-blind, placebo-controlled randomised trial

“…We conducted a phase II double-blind feasibility trial with UK GP practices cluster-randomised to give liquid or tablet preparation (for logistical reasons), and within each practice, eligible patients were individually randomised to Pelargonium sidoides root extract (EPs®7630 – Kaloba®) or matched placebo. The detailed protocol for this trial has already been published [ 33 ]. This trial adheres to CONSORT guidelines.…”