About: 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

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About: 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 Goto Sponge NotDistinct Permalink

An Entity of Type : schema:ScholarlyArticle, within Data Space : wasabi.inria.fr associated with source document(s)

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type	Academic Article research paper schema:ScholarlyArticle
isDefinedBy	Covid-on-the-Web dataset
title	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
Creator	Griffiths, Gareth Little, Paul Bell, Margaret Bostock, Jennifer Butler, Chris Moore, Michael Simpson, Catherine Webley, Frances Whitehead, Amy Willcox, Merlin Wrixon, Emma Yao, Lily Hay, Alastair
source	Medline; PMC
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.
has issue date	2019-07-31(xsd:dateTime)
bibo:doi	10.1186/s40814-019-0478-6
bibo:pmid	31384480
has license	cc-by
sha1sum (hex)	69cf21ea0c191cb1ea580856df13fea7b1608b00
schema:url	https://doi.org/10.1186/s40814-019-0478-6
resource representing a document's title	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
has PubMed Central identifier	PMC6668164
has PubMed identifier	31384480
schema:publication	Pilot Feasibility Stud
resource representing a document's body	covid:69cf21ea0c191cb1ea580856df13fea7b1608b00#body_text
is schema:about of	named entity 'acute infection' named entity 'Pelargonium' covid:arg/69cf21ea0c191cb1ea580856df13fea7b1608b00 named entity 'PELARGONIUM SIDOIDES' named entity 'IS A' named entity 'A COMMON' named entity 'SUFFICIENT' named entity 'MANAGEMENT' named entity 'CLINICAL TRIAL' named entity 'PATIENTS' named entity 'STRATEGIES' named entity 'ANTIBIOTIC RESISTANCE' named entity 'CONDUCT' named entity 'STRATEGY' named entity 'ADDRESS' named entity 'NOT SUSPECTED' named entity 'PROBLEM' named entity 'LIQUID' named entity 'RETAIN' named entity 'NEED' named entity 'DOMINANT' named entity 'PNEUMONIA' named entity 'WIDESPREAD' named entity 'SMALL' named entity 'OUR' named entity 'TRIAL' named entity 'CURRENT' named entity 'ORDER' named entity 'WHERE' named entity 'PELARGONIUM SIDOIDES ROOT EXTRACT' named entity 'ACUTE LOWER RESPIRATORY TRACT INFECTION' named entity 'USE OF' named entity 'PUBLICITY' named entity 'ACUTE INFECTION' named entity 'BENEFITS' named entity 'LOWER RESPIRATORY TRACT INFECTION' named entity 'SYMPTOM' named entity 'DO NOT' named entity 'BACKGROUND' named entity 'PRIMARY CARE' named entity 'PROVIDING' named entity 'TABLET' named entity 'EXTRACT' named entity 'FEASIBILITY STUDY' named entity 'EPS' named entity 'BURDEN' named entity 'RECOMMEND' named entity 'ANTIMICROBIAL RESISTANCE' named entity 'INCLUDED' named entity 'REDUCE' named entity 'EVIDENCE' named entity 'ALTERNATIVE' named entity 'INDEPENDENT' named entity 'ANTIBIOTICS' named entity 'MANAGED' named entity 'infection' named entity 'antibiotics' named entity 'current' named entity 'problem' named entity 'EPs' named entity 'lower respiratory tract infection' named entity 'Pelargonium sidoides' named entity 'antibiotic resistance' named entity 'clinical trials' named entity 'adverse events' named entity 'placebo' named entity 'H3N2' named entity 'CRP' named entity 'general practitioners'

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