HATRIC
Research type
Research Study
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.
IRAS ID
230883
Contact name
Michael Moore
Contact email
Sponsor organisation
University of Southampton
Eudract number
2016-004598-42
Duration of Study in the UK
1 years, 1 months, 28 days
Research summary
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 pelargonium, a herbal product extracted from the root of P. Sidoides in either liquid or tablet formulation, has some benefit in treating cough symptoms. The objective of this trial 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. GP practices will be cluster-randomised to give liquid or tablet preparation, and within each practice, eligible patients (adults presenting with an acute cough (≤21 days’ duration) associated with a lower respiratory infection, where pneumonia is not suspected) will be randomised to Pelargonium sidoides root extract EPs ®7630 or placebo. The use of a delayed prescription for antibiotics will be encouraged, but GPs will also be able to offer either an immediate prescription for antibiotics or no prescription. Patients will be asked to take the trial medication 3 times a day, 30 minutes before meals, until 2-3 days after symptom resolution. Patients will be asked to complete a daily symptom diary for up to 28 days after presentation. Patients can stop completing the diary 2 days after complete resolution of symptoms. A notes review will be undertaken 28 days after randomisation to document return visits to the GP with a lower respiratory tract infection.
REC name
South Central - Berkshire B Research Ethics Committee
REC reference
17/SC/0653
Date of REC Opinion
18 Dec 2017
REC opinion
Favourable Opinion