Table 2.
Schedule for enrollment, interventions, and assessment
| STUDY PERIOD | |||||
|---|---|---|---|---|---|
| Enrollment | Allocation | Post-allocation | Close-out | ||
| Time point | −t1 | 0 | day 1 | day 8 (±1d) | day 36 (±7d) |
| ENROLMENT: | |||||
| Informed consent | x | ||||
| Eligibility screen | x | ||||
| Random allocation | x | ||||
| INTERVENTIONS: | |||||
| Take medications |
|
||||
| ASSESSMENTS: | |||||
| Demographic data | x | ||||
| Medical history | x | ||||
| Vital signs | x | ||||
| Laboratory test | x | ||||
| Hwa-byung diagnosis | x | ||||
| PHQ-15 | x | x | x | ||
| ISI | x | x | x | ||
| SRI | x | x | x | ||
| VAS-HS | x | x | x | ||
| STAXI-S | x | x | x | ||
| EQ-5D | x | x | x | ||
| EQ-VAS | x | x | x | ||
| SF-36 | x | x | x | ||
| HRV | x | x | x | ||
| DITI | x | x | x | ||
| EEG | x | x | |||
| Adverse events | x | x | x | ||
PHQ-15: Patient health questionnaire-physical symptoms; ISI: Insomnia severity index; SRI: Stress response inventory; VAS-HS: Visual analogue scale for Hwa-byung symptoms; STAXI-S: State trait anger expression inventory-state anger; EQ-5D: EuroQol 5 dimensions questionnaire; EQ-VAS: EuroQol-visual analogue scales; SF-36: 36-item short form survey; HRV: Heart rate variability; DITI: Digital infrared thermal imaging; EEG: Electroencephalogram