Efficacy and Safety of Sipjeondaebo-Tang (Shi-Quan-Da-Bu-Tang) for Chronic Fatigue Syndrome: Study Protocol for a Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial
Table 1
Schedule of enrollment, intervention, and assessments.
Screening
Treatment period
Follow-up
Visit 1
Visit 2
Visit 3
(By phone)
Timepoint∼14 d
Day 1
Day 28 (±7)
Day 56 (±7)
Day 84–98
Patients
Informed consent
●
Demographics
●
Medical history
●
Physical examinations
●
●
●
Vital signs
●
●
●
●
Laboratory examination
●
●
Pregnancy test
●
HRV measurement
●
●
Body composition measurement
●
Confirmation of inclusion/exclusion criteria
●
●
Randomization
●
Intervention
Medication
●
●
Trial evaluation
Investigation of drug compliance
●
●
Investigation of concomitant medication
●
●
●
●
Adverse reactions
●
●
●
Outcomes
CIS
●
●
●
VAS for fatigue, happiness, and CDC criteria
●
●
●
FSS
●
●
●
EQ-5D-5L
●
●
●
PSQI-K
●
●
ChFI
●
●
●
QBYY-Q
●
●
●
Original symptom questionnaire
●
Abbreviations: HRV, heart rate variability; CIS, Checklist Individual Strength; VAS, visual analogue scale; CDC, center for disease control and prevention; FSS, fatigue severity scale; EQ-5D-5L, EuroQol 5-dimensions, 5-level questionnaire; PSQI-K, the Korean version of Pittsburgh Sleep Quality Index; ChFI, Chalder fatigue scale; QBYY-Q, Qi blood Yin Yang deficiency questionnaire.
