A Herbal Medicine, Gongjindan, in Subjects with Chronic Dizziness (GOODNESS Study): Study Protocol for a Prospective, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Clinical Trial for Effectiveness, Safety, and Cost-Effectiveness

Table 1

Study timetable.

	Screening	Randomization	Treatment				Follow-up
Visits	V1	V2	V3	V4	V5	V6	V7	V8	V9
Timepoint	Within 14 D	Day 0	14 D ± 3 D	28 D ± 3 D	42 D ± 3 D	56 D ± 3 D	4 M ± 1 W	8 M ± 1 W	12 M ± 1 W
Enrollment:
Informed consent	×
Demographics	×
Vital sign	×	×	×	×	×	×
Electrocardiography	×					×
Lab test	×					×
Medical history	×
Concomitant medication	×	×	×	×	×	×
Pregnancy test	×
CNS examination	×
Nystagmus examination	×
Eligibility assessment	×
Random allocation		×
Interventions:
GJD (1 pill/day)
Placebo (1 pill/day)
Assessments:
DHI	×	×	×	×	×	×
MVS		×		×		×
VAS		×		×		×
Frequency		×		×		×
BBS		×		×		×
FSS		×		×		×
GPE						×
K-BDI		×		×		×
STAI		×		×		×
QBYY-Q		×		×		×
EQ-5D		×		×		×	×	×	×
Cost information			×	×	×	×	×	×	×
New BI						×
Adverse events			×	×	×	×

BBS, Berg Balance Scale; BI, Blinding Index; D, day(s); DHI, Dizziness Handicap Inventory; EQ-5D, EuroQoL five dimensions’ questionnaire; FSS, Fatigue Severity Scale; GJD, Gongjindan; GPE, global perceived effect; K-BDI, Korean version of Beck’s Depression Inventory; M, month(s); MVS, mean vertigo scale; QBYY-Q, qi blood yin yang-deficiency questionnaire; STAI, State-Trait Anxiety Inventory; VAS, visual analogue scale; W, week(s).