Efficacy and safety of Dengyinnaotong Capsule in patients with Cognitive impairment caused by cerebral Small Vessel Disease: study protocol of a multicenter, randomized, open-label, controlled trial (De-CSVD trial)

Table 1 Schedule of data collection

Visits	Screening and baseline	Treatment period
Visits	0	1	2
Time points (weeks)	− 1 to 0	4	12
Time windows (days)	-	±7	±7
Informed consent	×
Inclusion and exclusion criteria	×
History of diagnosis and treatment	×
Vital signs and physical examinations	×	×	×
General biochemical examinations	×	×	×
12-lead electrocardiogram examination	×	×^a	×
CT or MRI examination	×	×^a	×^a
MoCA score	×		×
CDR score	×		×
Shape Trail Test	×	×^a	×
ADL score	×		×
DHI score	×^a	×^a	×^a
Tinetti POMA score	×^a	×^a	×^a
GDS score	×^a	×^a	×^a
Serum levels of Hcy, HS-CRP, and D-dimer	×	×	×
Audiological examination	×^a	×^a	×^a
Drug combination	×	×	×

MoCA Montreal Cognitive Assessment, CDR Clinical Dementia Rating, CT Computed tomography, MRI Magnetic resonance imaging, ADL Activities Of Daily Living, DH Dizziness Handicap Inventory, Tinetti POMA Tinetti performance-oriented mobility assessment, GDS Geriatric Depression Scale, Hcy homocysteine, HS-CRP High-sensitivity C-reactive protein
^aFor patients with relevant clinical manifestations or willing to be examined

ISSN: 1745-6215