Feasibility study of Pelargonium sidoides root extract EPs®7630 (Kaloba®) for lower respiratory tract infection in adults

Acute cough and respiratory infection is common and therefore distressing and costly both for individuals and the NHS. Antibiotics have limited benefits and cough mixtures are unhelpful.

A herbal medicine called Pelargonium is a promising candidate to treat cough.  In a review of research studies it resulted in 34% more patients being symptom free after a week compared to a placebo.  Seven studies giving pelargonium to adults were found and all showed improvement in cough symptoms.

We propose to evaluate the feasibility of using pelargonium tablets or liquid in adults who visit their GP with an acute cough as their main symptom and where the GP thinks the symptoms are caused by an infection  (bacterial or viral) but NOT pneumonia. The doctor will be able to prescribe antibiotics if needed either taken immediately or delayed for a few days.

Interventions

Pelargonium root extract is derived from the plant Pelargonium sidoides.  We will compare two weeks of active treatment using tablet or liquid pelargonium with patients taking a placebo (a tablet or liquid that looks the same but has no active ingredients). Treatments will be allocated in a random way and no one, including the doctor and the patient, will know which patient is getting which treatment.

How do we know if it is feasible?

The main outcomes will be whether patients find it acceptable to take either the liquid and tablet pelargonium, whether we can recruit enough patients into the study, whether the people involved complete the study documents, and how many of the patients complete the study questionnaires after the treatments have been given.

We will complete interviews with participants and with the GPs recruiting the patients in order to understand the issues around herbal medicines for acute cough so that later we may design a bigger more definitive study.

Summary

We will investigate whether a full trial of pelargonium is feasible in general practice.

Michael Moore (Southampton) with co-applicants George Lewith and Paul Little (Southampton), Alastair Hay (Bristol), Merlin Willcox and Chris Butler (Oxford), Andrew Flower, Caroline Eyles, Lily Yao, Gareth Griffiths (Southampton) and Jennifer Bostock and Margaret Bell (Patient and Public participants).

Amount awarded: £604,977