Influence of the Chungkookjang on histamine-induced wheal and flare skin response: a randomized, double-blind, placebo controlled trial

Table 1 A brief study schedule at every visit

	Screening Visit 1	Baseline Visit 2	Visit 3	Visit 4	Visit 5	Follow up (Visit 6)
	D-21 ~D-1	Week 0 D0	Week 4 D28	Week 8 D56	Week 12 D84	Week 16 D112
*Informed consent form*	◯
*Demographic information taking* ¹	◯
*Medical history taking*	◯
*Inclusion/exclusion criteria check*	◯	◯
*Physician examination* ²	◯				◯
*Drinking/smoking taking status* ³	◯				◯
*Vital sign measurement*	◯	◯	◯	◯	◯
*Concomitant drugs check*	◯	◯	◯	◯	◯
*Electrocardiogram(ECG)*	◯				◯
*Histamine skin prick test*	◯				◯
*Laboratory test* ⁴	◯				◯
*Histamine & ECP*		◯			◯
*Study product distribution*		◯	◯	◯
*Compliance checking*			◯	◯	◯
*Adverse event monitoring*			◯	◯	◯	◯
*Diet, physical exercise counseling* ⁵		◯	◯	◯

◯ : Item need to be performed during the visit
¹ Sex, date of birth, age, contact address and phone number
² Include present illness, past history taking
^3,5 Risk factors such as alcohol drinking, smoking, severe exercise and other dietary supplement intake will be managed
⁴ Blood test(WBC, RBC, hemoglobin, hematocrit, platelets count, AST, ALT, ALP, gamma-GTP, albumin, BUN, creatinine, glucose, total bilirubin, total protein, total-cholesterol, triglyceride, LDL-C, HDL-C, IgE), urine test(specific gravity, pH, Protein, Ketone, Glucose, bilirubin, urobilinogen, nitrite, microscopic (RBC, WBC))