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The University of Southampton
Southampton Clinical Trials Unit

HATRIC

Title

Short title: Herbal Alternative Treatment (Pelargonium) for lower Respiratory tract Infections with Cough in adults.

Full title: Feasibility study of Pelargonium sidoides root extract, EPs®7630 (Kaloba®), for the treatment of acute cough due to lower respiratory tract infection in adults: a double blind, placebo controlled randomised trial.

Description

Acute lower respiratory infection is common and despite the lack of evidence of benefit antibiotics are often prescribed. Identifying a safe and effective method of symptom control would likely further reduce antibiotic uptake. A Cochrane review suggests that Pelargonium sidoides root extract (Kaloba®) has some benefit. HATRIC is a Phase II feasibility study of Pelargonium sidoides root extract EPs®7630 (Kaloba®) for the treatment of lower respiratory tract infection in adults.

Objectives

The objective is to determine the feasibility of conducting a fully powered trial of Pelargonium sidoides root extract as an alternative to antibiotics for lower respiratory tract infections in UK primary care.

Trial Design

Hatric is a mixed methods double blind, placebo controlled, cluster randomised feasibility study with four arms. Practices will be randomised to tablet or liquid formulation. Patients will be randomised to active or placebo.

160 patients will be randomised to one of four groups:

1) Liquid Pelargonium sidoides root extract EPs®7630 - 30 drops 3x daily

2) Liquid placebo - 30 drops 3x daily

3) Tablet Pelargonium sidoides root extract EPs®7630 – one 20mg tablet 3x daily

4) Tablet placebo - one 20mg tablet 3x daily

 

Patients will take the trial medication daily until 2 – 3 days after symptoms have resolved but treatment duration should not exceed 2 weeks. The use of the delayed prescription strategy for antibiotics will be encouraged but clinicians will be able to offer one of three following antibiotic strategies in addition to the randomised intervention:

1) Immediate antibiotics

2) Delayed antibiotics

3) No antibiotics

Patients will complete a symptom diary for up to four weeks. A notes review will be undertaken at one month.

Trial Status

 Open to recruitment.

Population

Adults 18 years and over presenting to their GP with an acute cough (≤21 days' duration) as their main symptom and with symptoms localising to the lower tract (e.g. sputum, chest pain, dyspnoea wheeze), for which an infective diagnoses is judged very likely. 

Trial Team:

Senior Trial Manager:

Fran Webley (023 8120 3866)

Trial Manager:

Catherine Simpson (023 8120 5171)

Clinical Data Coordinator:

Emma Wrixon (023 8120 5687)

Contact information

Email: hatric@soton.ac.uk

Fax: 0844 7740 621

SAE Reporting:

Email: ctu@soton.ac.uk 

Fax: 0844 7740 621

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