Chinese Herbal Formula Huoxiang Zhengqi for Dampness Pattern in Atopic Dermatitis and Diarrhea-Predominant Irritable Bowel Syndrome: Rationale and Design of a Master Protocol

Table 3

Study schedule.

		RCTs				Observational studies
		Baseline	Treatment period		Follow-up	Baseline	Follow-up
		0 week	2^nd week (AD only)	4^th week	8^th week	0 week	4^th week	8^th week	12^th week
Patient	Informed consent	×				×
	Demographics	×				×
	Medical history	×				×
	Clinical manifestations	×		×	×	×	×	×	×
	CM pattern differentiation	×		×	×	×	×	×	×
Interventions	Randomization	×
	HXZQ or placebo
	Medical record					×	×	×	×
	Concomitant medications		×	×	×
Outcome measurements
AD patients (only)	EASI	×	×	×	×	×	×	×	×
	BSA	×	×	×	×	×	×	×	×
	NRS、 IGA	×	×	×	×	×	×	×	×
	Skindex-29、EQ-5L-5D	×	×	×	×	×	×	×	×
	EASI-50、EASI-75		×	×	×		×	×	×
IBS-Dpatients (only)	Adequate relieve
	IBS-SSS	×		×	×	×	×	×	×
	IBS-QOL	×		×	×	×	×	×	×
	EQ-5D-5L	×		×	×	×	×	×	×
Safety assessment	Vital signs	×		×	×	×	×	×	×
	Laboratory tests and ECG	×		×		×
	Adverse events		×	×	×		×	×	×

EASI, Eczema area and severity index; BSA, body surface area; NRS, numerical rating scale; IGA, investigator’s global assessment; Skindex-29, a dermatology-specific quality of life instrument; EQ-5D-5L, euroQol-5-dimensions-5-level; IBS-SSS, irritable bowel syndromes symptom severity score; IBS-QOL, the irritable bowel syndrome-quality of life questionnaire.