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Table 3 Summary of assessments at procedures

From: Effects of Gyejibongnyeong-hwan on dysmenorrhea caused by blood stagnation: study protocol for a randomized controlled trial

 

Screening

Treatment period

Follow-up

 

Visit 1

Visit 2

Visit 3

Visit 4

Visit 5

Visit 6

Informed Consent

x

     

History Taking1

x

     

Demographic information taking2

x

     

Pregnancy Check3

 

x

x

x

x

x

Blood Stagnation Diagnosis4

x

x

x

x

  

VAS5

x

x

x

x

x

x

McGill Questionnaire

x

x

x

x

x

x

Cox Menstrual Scale

x

x

x

x

x

x

Physical Examination

x

  

x

  

Liver function test6

x

  

x

  

Blood Cell Count7

x

  

x

  

Urinalysis8

x

  

x

  

Safety Assessment9

  

x

x

x

x

HRV

x

x

x

x

  

Compliance

  

x

x

  
  1. • Visit 1; Informed consent and screening procedure
  2. •Visit 2; Randomization and outcome assessment for baseline
  3. •Visit 4; Outcome assessment for primary objective
  4. x: Item has to be carried out for the visit
  5. 1 history of drug taking for the past one month, allergy and disease history, obstetric history, menarche and menstrual period, etc.
  6. 2 date of birth, age, height, and weight.
  7. 3 medical examination by interview.
  8. 4 a scale for diagnosing blood stagnation, has not been published.
  9. 5 the 100 mm visual analogue scale. The mean and the maximum pain during the menstrual period
  10. 6 AST, ALT, BUN, creatinine, ALP
  11. 7 WBC, RBC, hemoglobin, hematocrit, Platelet
  12. 8 protein, glucose, urobilinogen, ketone, RBC, WBC squamous cell
  13. 9 medical examination and self-report of adverse event
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Trials

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