Modified Sijunzi decoction in the treatment of ulcerative colitis in the remission phase: study protocol for a series of N-of-1 double-blind, randomised controlled trials

Table 1 Schedule of enrolment, interventions, and assessments

Time point		Enrolment	Allocation	Cycle1		Cycle2		Cycle3		Close-out
Time point		Enrolment	Allocation	Weeks1–8	Weeks9–16	Weeks17–24	Weeks25–32	Weeks33–40	Weeks41–48	Close-out
Enrolment	Eligibility screen	X
	Informed consent	X
	Allocation		X
Intervention	Modified Sijunzi decoction combined with mesalazine placebo or mesalazine combined with modified Sijunzi decoction placebo			X	X	X	X	X	X
Assessment	Laboratory tests	X		X	X	X	X	X	X	X
	Vital signs	X		X	X	X	X	X	X	X
	Adverse events			X	X	X	X	X	X
	VAS (abdominal pain, diarrhoea, bloody stool, mucus stool), stool frequency, SIBDQ, RFIPC, SHS, and TCM syndrome scale	X		X	X	X	X	X	X

RFIPC Rating Form of Inflammatory Bowel Disease Patient Concerns, SHS Short Health Scale, SIBDQ Short Inflammatory disease Patient Concerns, TCM traditional Chinese medicine, VAS visual analogue scale

ISSN: 1745-6215