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The University of Southampton
Global Network for Anti-Microbial Resistance and Infection Prevention

Pelargonium feasibility study

ctu
delivering high quality trials that will directly influence routine clinical practice

In a new study at the University of Southampton's NIHR Clinicall Trials Unit, team will investigate the use of a herbal remedy using pelargonium to treat acute cough and respiratory infection. This is a common and distressing condition and treatments are costly both for individuals and the NHS. To help reduce antibiotic use, this study is looking at the feasibility of treatment using Pelargonium sidoides root extract EPs®7630 (Kaloba®) for lower respiratory tract infection in adults.

 

Pelargonium root extract is derived from the plant Pelargonium sidoides. Tablets, liquid and matching placebos will be prepared by Schwabe who currently manufacture and market the product in Germany. 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.

The research proposes 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 pneumonia is not suspected. Participants will be identified in primary care when presenting with acute cough illness. Use of a delayed prescription will be encouraged, but GPs will also be able to offer immediate prescriptions where advisable to maximise recruitment and generalisability. Participants will complete a validated daily diary of symptoms until symptom resolution or for 28 days.

This will be a mixed methods feasibility study with a double blind placebo controlled cluster randomised trial with four groups. Whether patients receive tablet or liquid formation will be randomised. Whether patients receive the active medicine or a placebo will also be randomised. Researchers will compare two weeks of active treatment with tablet or liquid pelargonium with patients taking a placebo. No one, including the GPs and patients, will know which patient is getting which treatment.

 

Some expected outcomes:

  1. will patients find it acceptable to take pelargonium - either the liquid or the tablet form?
  2. can  enough patients be recruited into the study?
  3. will the patients involved be willing to complete the study documents?
  4. how many of the patients will complete the final study questionnaires after the treatments are complete?

Researchers will conduct interviews with patients and with participating GPs. It is hoped that the study will give a greater understanding of patient/GP reactions to herbal medicines in treating acute cough and that the data collected will allow the team to design a larger and more definitive study.

 

NAMRIP members:

Jacqui Nuttall, Senior Clinical Trials Manager, Group Lead

Fran Webley, Senior Clinical Trials Manager

 

 

 

 

 

 

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