HATRIC - Herbal Alternative Treatment (Pelargonium) for lower Respiratory tract Infections with Cough in adults

Conditions

Specialty: Primary Care, Primary sub-specialty: Infectious diseases and microbiology

Merlin Willcox, Catherine Simpson, Sam Wilding, Beth Stuart, Dia Soilemezi et al. (20 authors)

BMC Complementary Medicine and Therapies2021-01-2912 citations

HATRIC: a study of <i>Pelargonium sidoides</i> 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.

Whitehead A, Simpson C, Willcox M, Webley F, Hay AD, Butler C, Yao L, Wrixon E, Bell M, Bostock J, Little P, Griffiths G, Moore M.

2019-07-315 citations

10.1186/s40814-019-0478-6

Interventions

This is a multicentre, double-blind placebo-controlled feasibility trial of Pelargonium sidoides root extract EPs®7630 (Kaloba®). The trialists aim to recruit 160 adults, 18 years and

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Adults 18 years and over 2. Presenting with an acute cough (=21 days' duration) as their main symptom 3. Presenting with symptoms localising to the lower tract (e.g. sputum, chest pain, dyspnoea, wheeze), for which an infective diagnosis is judged very likely 4. Willing and able to give written informed consent

Exclusion criteria

Exclusion criteria: 1. Suspected pneumonia (i.e., complicated lower-respiratory-tract infection) on the basis of focal chest signs (focal crepitations, bronchial breathing) and systemic features (severe breathlessness, high fever, vomiting, severe diarrhoea) 2. Signs of severity which may warrant hospital admission (e.g. SpO2 130) 3. Exacerbation of COPD 4. Serious chronic disorders where immediate antibiotics are needed (e.g. cystic fibrosis, valvular heart disease) 5. Unable to give informed consent or complete trial paperwork (including the patient diary) 6. Difficulty reading and understanding English and therefore unable to give informed consent or complete the trial paperwork (including the patient diary) 7. Known or suspected pregnancy 8. Women at risk of pregnancy (i.e. not on effective contraception – combined oral contraceptive pill, an intrauterine hormonal device or subcutaneous hormonal implant) 9. Currently breastfeeding 10. Known immunodeficiency state or chemotherapy 11. Currently taking oral steroids 12. Using a Pelargonium sidoides / Kaloba® preparation and unwilling or unable to discontinue for the study period. 13. Hypersensitivity to pelargonium sidoides preparations or to the Kaloba brand 14. Increased tendency to bleeding or is taking coagulation-inhibiting drugs (e.g. warfarin) 15. Severe hepatic and renal diseases (Chronic Kidney Disease Stage 4, GFR < 30), as no adequate data are available in these areas 16. Rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption (tablet formulation only) 17. Previously entered the HATRIC trial 18. Recruited to another interventional trial in the previous 6 weeks

Design outcomes

Primary

Measure	Time frame
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. Feasibility objectives and endpoints used to evaluate are detailed below: 1. Eligibility: Number of patients included in and number excluded, with reasons, from the trial from on-site screening logs 2. Recruitment: Ability to recruit patients into the intervention from those attending primary care settings from on-site enrolment records – monthly rate/site adjusted for site list size 3. Randomisation: Willingness to be randomised from the proportion of eligible patients recruited 4. Retention: Across the duration of the intervention and return of a fully completed diary from quantitative data from enrolment, withdrawal rate from study and completion of outcome measures 5. Intervention compliance from diary data and returned medication 6. Patient preference for liquid/tablet formulation from diary data, returned medication and recruitment data 7. Acceptability of the patient diaries, patients’ willingness to complete them and the importance of telephone/text contact from quantitative data collection - percentage of patients returning completed diaries 8. Success of delayed antibiotic strategy from diary data on day antibiotics commenced 9. Need for stratification by antibiotic strategy in main study from proportion allocated to immediate and delayed antibiotic strategy 10. To inform sample size for future trials from rate of outcome measures in the control group. 11. To identify the key resource items to be collected and how often to collect EQ-5D-5L questionnaires in the main trial from data collected in patient diaries and case note reviews	—

Measure

Time frame

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. Feasibility objectives and endpoints used to evaluate are detailed below: 1. Eligibility: Number of patients included in and number excluded, with reasons, from the trial from on-site screening logs 2. Recruitment: Ability to recruit patients into the intervention from those attending primary care settings from on-site enrolment records – monthly rate/site adjusted for site list size 3. Randomisation: Willingness to be randomised from the proportion of eligible patients recruited 4. Retention: Across the duration of the intervention and return of a fully completed diary from quantitative data from enrolment, withdrawal rate from study and completion of outcome measures 5. Intervention compliance from diary data and returned medication 6. Patient preference for liquid/tablet formulation from diary data, returned medication and recruitment data 7. Acceptability of the patient diaries, patients’ willingness to complete them and the importance of telephone/text contact from quantitative data collection - percentage of patients returning completed diaries 8. Success of delayed antibiotic strategy from diary data on day antibiotics commenced 9. Need for stratification by antibiotic strategy in main study from proportion allocated to immediate and delayed antibiotic strategy 10. To inform sample size for future trials from rate of outcome measures in the control group. 11. To identify the key resource items to be collected and how often to collect EQ-5D-5L questionnaires in the main trial from data collected in patient diaries and case note reviews

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Secondary

Measure	Time frame
There are no secondary outcome measures	—

Countries

United Kingdom

Outcome results

None listed