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Table 1 Study process treatment and outcome measurements

From: Effects of herbal medicine for dysmenorrhea treatment on accompanied acne vulgaris: a study protocol for a randomized controlled trial

Activity

Visit 1

Visit 2

Visit 3

Visit 4

Visit 5

Visit 6

Visit 7

Visit 8

Time Schedule

Week 1

Baseline

Week 2

Week 4

Week 6

Week 8

Week 12

Week 16

Window visit

 

±3 days

±3 days

±3 days

±3 days

±3 days

±3 days

±3 days

Demographic information-taking

X

       

Informed consent form

X

       

General medical history-taking

X

       

Photographing the patient’s face Count of inflammatory/non-inflammatory lesions

X

X

X

X

X

X

  

Blood tests (liver function test, renal function test)

X

    

X

  

Blood tests

 

X

   

X

  

Urine pregnancy test

X

    

X

  

Randomization & allocation

 

X

      

Investigational Produce

 

X

X

X

X

   

Numeric rating scale (menstrual pain)

 

X

 

X

 

X

X

X

Verbal multidemensional scoring system grade

X

X

 

X

 

X

X

X

Investigator’s Static Global Assessment Scale of Facial Acne Vulgaris

 

X

X

X

X

X

  

Numeric rating scale (acne)

 

X

X

X

X

X

X

X

Monitoring adverse events

  

X

X

X

X

X

X

Compliance check

  

X

X

X

X

  

Blinding check

     

X

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