Efficacy and safety of Ojeok-san in Korean female patients with cold hypersensitivity in the hands and feet: study protocol for a randomized, double-blinded, placebo-controlled, multicenter pilot study

Table 1 The detailed trial schedule

		Study period
		Screening	Treatment period			Follow-up period
Visit		visit 1 (D − 7~ − 2)	visit 2 (D 1)	visit 3 (D 28)	visit 4 (D 56)	FU1 (D 84)
Informed consent		●
Eligibility assessment		●
Random allocation			●
Socio-demographic investigation^a		●
Medical and drug history^b		●
IP distribution	OJS		●	●
IP distribution	Placebo		●	●
Assessment
General physical examination		●	●	●	●	●
Severity of CHHF (VAS)		●	●	●	●	●
Skin temperature measurement^c		●	●	●	●	●
Quality of life (WHOQOL-BREF)			●	●	●	●
Cold stress test			●		●
Vital signs		●	●	●	●	●
Anthropometric variables		●	●	●	●
Chest x-ray and EKG		●
Clinical pathological laboratory test		●			●
Medical and drug history check-up			●	●	●	●
Adverse event check-up				●	●	●
Compliance check-up				●	●
Blind assessment					●

^aSex, date of birth, age, level of education, occupation, marital status, diet, exercise, smoking, drinking, sleeping condition, motivation of participation, etc.
^bIncluding medical and drug history of CHHF
^cSkin temperature of palm (PC9) and anterior upper arm (LU4) will be measured at the screening visit; skin temperature of thigh (ST32) and instep of foot (LR3) will also be collected additionally at visit 2
Abbreviations: CHHF cold hypersensitivity in the hands and feet, EKG electrocardiogram, IP investigational products, OJS ojeok-san, VAS Visual Analog Scale, WHOQOL-BREF WHO Quality of Life abbreviated version

ISSN: 1745-6215