The Chinese herbal formula Huoxiang Zhengqi for diarrhea-predominant irritable bowel syndrome (CHAIRS): a study protocol for a double-blinded randomized controlled trial

Table 1 Content for the schedule of enrollment, interventions and assessments

Items	Study phase	Screening	Baseline	Treatment period				Follow-up period
Items	Time	-1W	0W	1W	2W	3W	4W	5W	6W	7W	8W
Subjects selection	Enrolment	√
	Eligibility screen	√
	Informed consent	√
	Randomization		√
Intervention	HXZQ group			√	√	√	√
Intervention	Placebo group			√	√	√	√
Outcome assessments	Baseline assessments		√
	AR		√	√	√	√	√	√	√	√	√
	IBS-SSS, IBS-QOL, EQ-5D-5L, CM symptoms questionnaire		√				√				√
Safety assessment	Laboratory tests		√				√
Safety assessment	Adverse events

CM Chinese medicine, IBS-D Diarrhea-predominant irritable bowel syndrome, HXZQ Huoxiang Zhengqi oral liquid, AR Adequate relief, IBS-SSS Irritable Bowel Syndromes Symptom Severity Score, IBS-QOL Irritable Bowel Syndrome-Quality of Life Questionnaire, EQ-5D-5L EuroQol-5-Dimensions-5-Level

ISSN: 1745-6215