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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