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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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