Table 3.

Summary of assessments at procedures

	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

• Visit 1; Informed consent and screening procedure

•Visit 2; Randomization and outcome assessment for baseline

•Visit 4; Outcome assessment for primary objective

x: Item has to be carried out for the visit

¹ history of drug taking for the past one month, allergy and disease history, obstetric history, menarche and menstrual period, etc.

² date of birth, age, height, and weight.

³ medical examination by interview.

⁴ a scale for diagnosing blood stagnation, has not been published.

⁵ the 100 mm visual analogue scale. The mean and the maximum pain during the menstrual period

⁶ AST, ALT, BUN, creatinine, ALP

⁷ WBC, RBC, hemoglobin, hematocrit, Platelet

⁸ protein, glucose, urobilinogen, ketone, RBC, WBC squamous cell

⁹ medical examination and self-report of adverse event