Gyejigachulbutang (Gui-Zhi-Jia-Shu-Fu-Tang, Keishikajutsubuto, TJ-18) in Degenerative Knee Osteoarthritis Patients: Lessons and Responders from a Multicenter Randomized Placebo-Controlled Double-Blind Clinical Trial

Table 1

Study design.

Assessment	Enrollment	Treatment phase			Follow-up phase
	Screening (−2 weeks∼day 0)	Visit 1 (0 weeks)	Visit 2 (2 weeks)	Visit 3 (4 weeks)	Visit 4 (8 weeks)
Informed consent	○
Inclusion/exclusion criteria	○
Vital signs and physical examination	○	○	○	○	○
Demographic characteristics	○
Medical history	○
Treatment expectancy questionnaire	○
Blood test	○			○
EKG	○			○
Radiography of both knee	○
Randomization		○
VAS	○	○	○	○	○
K-WOMAC		○	○	○	○
EQ-5D		○	○	○	○
PGIC		○	○	○	○
Medication compliance			○	○
Check rescue medicine and concomitant treatment			○	○	○
Safety assessment		○	○	○	○
Blinding test				○
Medication administration		○	○
Participants education	○	○	○	○

VAS, visual analogue scale; K-WOMAC, Korean Western Ontario and Mcmaster Universities Osteoarthritis Index; EQ-5D, European Quality of life Five Dimensions questionnaire; PGIC, Patient Global Impression of Change. Blood 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), total bilirubin, blood urea nitrogen (BUN), creatinine, and electrolytes (Na, K, and Cl).