Table 1.
Study schedule.
| Assessment | Enrollment | Treatment phase |
Follow-up phase | ||
|---|---|---|---|---|---|
| Screening |
Before V1 (0 weeks) |
After V8 (4 weeks) |
After V16 (8 weeks) |
V17 (12 weeks) |
|
| Informed consent | X | ||||
| Demographic characteristics | X | ||||
| Medical history | X | ||||
| Vital signs and physical examination | X | Every visit before intervention | |||
| EKG and X-ray | X | ||||
| Blooda and urine test | X | ||||
| SCID-5 | X | ||||
| Inclusion / exclusion criteria | X | ||||
| Jing Ji and Zheng Chong | X | ||||
| Mibyeong | X | ||||
| KS-15 | X | ||||
| KSRI-SF | X | ||||
| PCL-5-K | X | X | X | X | |
| IES-R-K | X | X | X | X | |
| CGI-I | X | X | X | X | |
| BAI | X | X | X | X | |
| BDI | X | X | X | X | |
| ISI | X | X | X | X | |
| Hwa-byung | X | X | X | X | |
| SF-36 | X | X | X | X | |
| EQ-5D, EQ-VAS | X | X | X | X | |
| Cost | X | X | X | X | |
| CSEI-S | Every visit before and after intervention | ||||
| MRM | Every visit before and after intervention | ||||
| QEEG | X | X | X | ||
| Safety assessment | During trial, including waiting and follow-up period | ||||
aBlood test: red blood cells (RBCs), white blood cell (WBCs), hemoglobin, hematocrit, platelets, erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), aspartate aminotransferase (AST), alanine aminotransferase (ALT), Gamma-glutamyl transferase (γ-GTP), alkaline phosphatase (ALP), total bilirubin, glucose, blood urea nitrogen (BUN), creatinine, electrolytes (Na, K, Cl), total protein, albumin, and thyroid function test (T3, TSH, Free T4).
Women of childbearing age will be further tested for urine hCG to identify pregnancy before the first treatment. A 3-day window will be allowed for each visit.
If necessary, unscheduled visits will be allowed and recorded in the medical record and care report form.
Abbreviations: EKG, electrocardiogram; KS-15, Korea Sa sang Constitutional Diagnostic Questionnaire-15; KSRI-SF, Korean Sex Role Inventory-Short Form; PCL-5-K, The Posttraumatic Stress Disorder Checklist for DSM-5; IES-R-K, Impact of Event Scale-Revised; CGI-I, The Clinical Global Impression–Improvement scale; BAI, Beck Anxiety Inventory; BDI, Beck Depression Inventory; ISI, Insomnia Severity Index; SF-36, Short Form Health Survey-36; EQ-5D, EuroQoL-5 Dimension; EQ-VAS, EuroQoL-visual analog scale; CSEI-S, The Core Seven-Emotions Inventory Short Form; MRM, Mentalizing the Rooms of Mind; QEEG, Quantitative Encephalogram.