Efficacy and safety of gyejigachulbutang (Gui-Zhi-Jia-Shu-Fu-Tang, Keishikajutsubuto, TJ-18) for knee pain in patients with degenerative knee osteoarthritis: a randomized, placebo-controlled, patient and assessor blinded clinical trial

Table 1 Study schedule

Assessment	Enrollment	Treatment phase			Follow-up phase
Assessment	Screening (−2 weeks ~ day 0)	Visit 1 (0 weeks)	Visit 2 (2 weeks)	Visit 3 (4 weeks)	Visit 4 (8 weeks)
Informed consent	X
Inclusion/exclusion criteria	X
Vital signs and physical examination	X	X	X	X	X
Demographic characteristics	X
Medical history	X
Treatment expectancy questionnaire	X
Blood test^a	X			X
Electrocardiogram	X			X
Urine hCG (only women)	X
Radiography of both knees	X
Randomization		X
VAS	X	X	X	X	X
K-WOMAC		X	X	X	X
EQ-5D		X	X	X	X
PGIC		X	X	X	X
Medication compliance			X	X
Check rescue medicine and concomitant treatment			X	X	X
Safety assessment		X	X	X	X
Blinding test				X
Medication administration		X	X
Participant education	X	X	X	X

If necessary unscheduled visits are allowed and are recorded in the medical record and case report form
EQ-5D EuroQoL-5D, hCG human chorionic gonadotrophin, K-WOMAC Korean Western Ontario and McMaster Universities Osteoarthritis Index, PGIC patient global impression of change, VAS visual analogue scale
^aBlood test consists of red blood cell count (RBC), white blood cell count (WBC), 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, Cl); rheumatoid factor will be checked only at the screening visit for screening purposes; women of childbearing age are further tested for urine hCG to identify pregnancy before the first treatment; each visit allows a window of 3 days

ISSN: 1745-6215