Effectiveness of modified Buzhong Yiqi decoction in treating myasthenia gravis: study protocol for a series of N-of-1 trials

Table 1 Schedule of enrolment, interventions, outcomes, and safety assessments

Time point		Enrolment	Allocation	Cycle1		Cycle2		Cycle3		Close-out
Time point		Enrolment	Allocation	Weeks 1–4	Weeks 6–9	Weeks 11–14	Weeks 16–19	Weeks 21–24	Weeks 26–29
Enrolment	Eligibility screen	√
	Informed consent	√
	Allocation		√
Intervention	MBYD granules or placebo with the conventional western medicine			√	√	√	√	√	√
Outcome	QMG score	√		√	√	√	√	√	√	√
	TCM syndrome score; MGC; MG-ADL; MG-QOL	√		√	√	√	√	√	√	√
	The level of CD4+ Foxp3+ Treg cells and cytokines (IL-4, IL-17A, INF-γ, TGF-β)	√		√	√	√	√	√	√
	Gut microbiota	√		√	√	√	√	√	√
Safety assessment	Laboratory tests	√		√	√	√	√	√	√	√
	Vital signs	√		√	√	√	√	√	√	√
	Adverse events	√		√	√	√	√	√	√	√

ISSN: 1745-6215