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Table 1 A brief study schedule at every visit

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

  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   ◯ ◯ ◯   
  1. ◯ : Item need to be performed during the visit
  2. 1 Sex, date of birth, age, contact address and phone number
  3. 2 Include present illness, past history taking
  4. 3,5 Risk factors such as alcohol drinking, smoking, severe exercise and other dietary supplement intake will be managed
  5. 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))
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