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Table 4 Study schedule for the Onkyeong-tang (OKT) clinical trial

From: Efficacy and safety of Onkyeong-tang in treating cold hypersensitivity in the feet of Korean women: protocol for a double-blind, randomized, placebo-controlled, parallel-group, multicenter clinical study

 

Screening

Treatment period

Follow-up

Visit 1

(day − 7 through − 2)

Visit 2

(day 0)

Visit 3

(day 28 ± 3)

Visit 4

(day 56 ± 3)

Visit 5

(day 84 ± 3)

Informed consent

    

Eligibility criteria

    

Randomization

 

   

Medication compliance

  

 

Vital signs

Body measurementsa

Collection of demographic, sociological,b and gynecological information

    

Medical history

General physical examination

Thermometer measurementc

VAS

Monitoring of AE

  

Questionnaire of Pattern Identification

    

Questionnaire of Cold Hypersensitivity

 

   

Cold stress test

 

 

 

WHOQOL-BREF

 

 

 

Laboratory testsd

  

 

Chest X-ray & ECG

    

Medication

 

  

Test of blindness

   

 
  1. a Height, weight, and BMI, but only weight for visits 2, 3, 4, and 5
  2. b Age, occupation, digestion, exercise, smoking, drinking, sleep, etc.
  3. c Thermometer measurement of ST32, LR3, PC8, and LU4 at every visit
  4. d Screening: Hematological examination (WBCs, RBCs, Hb, platelets), blood chemistry test (BUN, Cr, AST, ALT, r-GTP, glucose), thyroid function test (free T4, TSH), urine test, pregnancy test (urine hCG)
  5. Visit 4: Hematological examination (WBCs, RBCs, Hb, platelets), blood chemistry test (BUN, Cr, AST, ALT, r-GTP)
  6. Abbreviations: AE adverse event, ALT alanine aminotransferase, AST aspartate aminotransferase, BMI body mass index, BUN blood urea nitrogen, Cr creatinine, ECG electrocardiogram, r-GTP gamma-glutamyl transpeptidase, Hb hemoglobin, hCG human chorionic gonadotropin, RBC red blood cell, TSH thyroid-stimulating hormone, VAS Visual Analog scale, WBC white blood cell, WHOQOL-BREF World Health Organization Quality of Life Scale-abbreviated version