Skip to main content

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

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

Time point Enrolment Allocation Cycle1 Cycle2 Cycle3 Close-out
Weeks 1–4 Weeks 6–9 Weeks 11–14 Weeks 16–19 Weeks 21–24 Weeks 26–29  
Enrolment Eligibility screen         
Informed consent         
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