The efficacy and safety of Fufangdanshen tablets (Radix Salviae miltiorrhizae formula tablets) for mild to moderate vascular dementia: a study protocol for a randomized controlled trial

Table 1 Study timeline and endpoints

Items	−2 weeks (run-in)	0 week (baseline)	12 weeks (mid-term follow-up)	24 weeks (endpoint)	36 weeks (follow-up)
Inclusion criteria		√
Exclusion criteria		√
MRI scan	√
Informed consent	√
General information	√
Vital signs	√	√	√	√	√
MMSE	√	√	√	√	√
HAMD	√
HIS	√
ADAS-cog		√	√	√	√
CIBIS		√
CIBIC-plus			√	√	√
ADL		√	√	√	√
Safety measure		√	√	√
Adverse event		√	√	√
Concomitant drugs		√	√	√	√

CIBIS Clinician Interview-Based Impression of Severity, CIBIC-plus Clinician Interview-Based Impression of Change

ISSN: 1745-6215