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Table 4 Study schedule for the trial

From: The efficacy and safety of Sipjeondaebo-tang in Korean patients with cold hypersensitivity in the hands and feet: a protocol for a pilot, randomized, double-blind, placebo-controlled, parallel-group clinical trial

 

Screening

Treatment period

Follow-up

Visit 1

(day − 7 to − 2)

Visit 2

(day 0)

Visit 3

(day 28 ± 3)

Visit 4

(day 56 ± 3)

Visit 5

(day 84 ± 3)

Informed consent

    

Inclusion/exclusion criteria

    

Randomization

 

   

Drug compliance

  

 

Vital signs

Body measurementa

Demographic, sociological, and gynecological informationb

    

Medical historyc

General physical examination

Thermometer measurementd

Visual Analogue Scale

Adverse event monitoring

  

Pattern Identification Questionnaire

    

WHOQOL-BREF

 

 

Laboratory testse

  

 

Chest X-ray scan and ECG

    

Medication

 

  

Blindness test

   

 
  1. ECG electrocardiogram, WHOQOL-BREF World Health Organization Quality of Life Scale Abbreviated Version
  2. aHeight and weight, but only weight for visit 2 and follow-up
  3. bAge, job, digestion, exercise, smoking habit, drinking habit, sleep pattern, etc.
  4. cIncluding general medical history and history related to cold hypersensitivity in the hands and feet
  5. dTemperature measurement of both PC8 and LU4 at every visit and both ST32 and LR3 at visit 2
  6. eScreening: hematological examination (white blood cells, red blood cells, hemoglobin, platelet), blood chemistry test (blood urea nitrogen, creatinine, aspartate aminotransferase, alanine aminotransferase, gamma-glutamyl transpeptidase, glucose), thyroid function test (free thyroxine, thyroid-stimulating hormone), urine test, pregnancy test (urine human chorionic gonadotropin). Visit 4: hematological examination (white blood cells, red blood cells, hemoglobin, platelet), blood chemistry test (blood urea nitrogen, creatinine, aspartate aminotransferase, alanine aminotransferase, gamma-glutamyl transpeptidase)