HATRIC: a study of Pelargonium sidoides 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

Table 3 SPIRIT figure for HATRIC trial

Observation/procedure	Person undertaking the specified event	Timings of visit/contact
Observation/procedure	Person undertaking the specified event	Screening/registration D1	D2-3	D14	D28	D35
Informed consent	GP/nurse¹/HCA¹/CTA¹	X
Inclusion/exclusion criteria	GP/nurse prescriber¹	X
Baseline symptoms²	GP/nurse	X
Relevant medical history	GP/nurse	X
Vital signs³	GP/nurse	X
Issue trial medication	GP/nurse	X
Issue patient diary	GP/nurse	X
Completion of patient diary (days 1–28)	Patient	X	X	X	X
Phone call to patient (diary assessment)	SCTU		X	X	X	Only if diary not returned or incomplete
Completion of diary by recall	Patient/SCTU					X
Adverse event notification⁴	Patient/SCTU		X	X	X
Adverse event (AE) assessing	GP		X	X	X
AE recording/reporting⁴	GP/nurse		X	X	X
Concomitant medication (only to be recorded in the event of an SAE and specified AEs)	GP/nurse		X	X	X
SAE assessing	GP		X	X	X
SAE reporting	GP/nurse		X	X	X
Medical note review	GP/nurse				X

¹In line with local GP surgery procedures with demonstrable and appropriate level of training. Specific duties delegated by the PI
²The severity of cough, phlegm, shortness of breath, wheeze, blocked or runny nose, chest pain, muscle aches, headaches, disturbed sleep, general feeling of being unwell, fever, and interference with normal activities
³Blood pressure; heart rate; temperature; oxygen saturation levels (Sats); C-Reactive protein (CRP), if measured; and the presence of wheeze or crackles in the chest
⁴Patients will be asked to notify their GP/nurse of specified adverse events. In addition, specified adverse events that are discovered by SCTU staff during patient contact phone calls will be notified immediately to GP/nurse. Reporting and recording of all AEs is carried out by GP/nurse. NB: the Patient is free to withdraw consent at any time without providing a reason. When withdrawn, the patient will continue to receive standard clinical care. Follow-up data will continue to be collected (unless the patient has specifically stated that they do not want this to happen)

ISSN: 2055-5784