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

Table 1 Study process treatment and outcome measurements

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