Pelargonium sidoides root extract for the treatment of acute cough due to lower respiratory tract infection in adults: a feasibility double-blind, placebo-controlled randomised trial

Table 4 Patient-reported Adverse events

Characteristic	Liquid Kaloba® (n = 42)	Liquid Placebo (n = 40)	Tablet Kaloba® (n = 26)	Tablet Placebo (n = 26)	Total (n = 134)
Number of patients that experienced at least one Side-effect – n (%)¹	7 (16.7%)	3 (7.5%)	2 (8.0%)	2 (7.7%)	14 (10.5%)
Total number of Side-effects – n²	28 (68.3%)	8 (19.5%)	3 (7.3%)	2 (4.9%)	41 (100.0%)
Summary of Side-effects – n (%)²
Frequent bouts of Vomiting³	1 (3.6%)	0 (0.0%)	0 (0.0%)	0 (0.0%)	1 (2.4%)
Bad taste in mouth	0 (0.0%)	0 (0.0%)	0 (0.0%)	1 (50.0%)	1 (2.4%)
Burping	0 (0.0%)	3 (37.5%)	0 (0.0%)	0 (0.0%)	3 (7.3%)
Cough	4 (14.3%)	0 (0.0%)	0 (0.0%)	0 (0.0%)	4 (9.8%)
Diarrhoea	1 (3.6%)	0 (0.0%)	1 (33.3%)	0 (0.0%)	2 (4.9%)
Disturbed Sleep	1 (3.6%)	0 (0.0%)	0 (0.0%)	0 (0.0%)	1 (2.4%)
Drowsiness	1 (3.6%)	0 (0.0%)	0 (0.0%)	0 (0.0%)	1 (2.4%)
Feeling Bloated	0 (0.0%)	3 (37.5%)	0 (0.0%)	0 (0.0%)	3 (7.3%)
Feeling Unwell	3 (10.7%)	0 (0.0%)	0 (0.0%)	0 (0.0%)	3 (7.3%)
Headaches	3 (10.7%)	1 (12.5%)	0 (0.0%)	0 (0.0%)	4 (9.8%)
Phlegm	5 (17.9%)	0 (0.0%)	0 (0.0%)	0 (0.0%)	5 (12.2%)
Muscle Aches	2 (7.1%)	0 (0.0%)	0 (0.0%)	0 (0.0%)	2 (4.9%)
Nausea⁴	2 (7.1%)	0 (0.0%)	0 (0.0%)	0 (0.0%)	2 (4.9%)
Runny Nose	3 (10.7%)	0 (0.0%)	0 (0.0%)	0 (0.0%)	3 (7.3%)
Stomach Pain	0 (0.0%)	0 (0.0%)	2 (66.6%)	1 (50.0%)	3 (7.3%)
Upset Stomach	0 (0.0%)	1 (12.5%)	0 (0.0%)	0 (0.0%)	1 (2.4%)
Wheeze	2 (7.1%)	0 (0.0%)	0 (0.0%)	0 (0.0%)	2 (4.9%)

¹ Denominator is the number of patients randomised in the study
² Denominator is number of Side-effects on study
³ Patient initially recorded this over all 4 weeks, however related AE only covers period of first week
⁴ One patient recorded nausea in Week 1 diary and Week 2 diary, unsure if this is the same event

ISSN: 2662-7671