Chinese herbal medicine granules (PTQX) for children with moderate to severe atopic eczema: study protocol for a randomised controlled trial

Table 1 Schedule of the trial

Items	Screening/run-in period	Visit 1 (baseline)	Visit 2	Visit 3	Visit 4 (endpoint)	Visit 5 (follow-up)
Week of the trial	−2/−1	0	4	8	12	16
Demographic information-taking	+
Informed consent form (PICF)	+
General medical history-taking	+
Severity of AE for inclusion and exclusion of the participants (NESS)	+
Blood tests	+		+		+
Clinical sign of AE (EASI)		+	+	+	+	+
Symptoms (POEM)		+	+	+	+	+
QoL score (CDLQI)		+	+	+	+	+
Distributions of treatment or placebo products		+	+	+
Daily medical record	+	+	+	+	+	+
Monitor of adverse event		+	+	+	+	+
Compliance check		+	+	+	+	+
Survey of participation						+

Abbreviations: AE atopic eczema, CDLQI Children’s Dermatology Life Quality Index, EASI Eczema Area and Severity Index, NESS Nottingham Eczema Severity Score, PICF participant information and consent form, POEM Patient-Oriented Eczema Measure, QoL quality of life

ISSN: 1745-6215