The primary purpose of this study is to administer Dangguijakyaksan repeatedly to a woman with mild menstruation, and analyzed by non-targeted profiling of endogenous metabolites in plasma and urine before and after administration to find out about metabolic changes due to Dangguijakyaksan. Secondary purpose is to look at the effectiveness and safety of the Dangguijakyaksan. Through this, it is confirmed as a biomarker (biomarker) associated with the effect and safety of Dangguijakyaksan, and to find a specific evidence for the mechanism of Dangguijakyaksan action.

Basic Science

1) Information on investigational drugs
Kracie Dangguijakyaksan, 3g/1pack

2) schedule
[Visit 1]
Subjects visit Hospital on the 3rd day of their first menstruation after screening, receive and take 40 days of Dangguijakyaksan.
[Visit 2]
Subjects visit Hospital on the 3rd day of the second menstruation, and return the remaining Dangguijakyaksan, provided at visit 1, along with the packaging, and receive another 40-day supply of Dangguijakyaksan. 
[Visit 3]
Subjects visit Hospital on the 3rd day of their third menstruation, and perform the examination and sample collection scheduled for visit 3. 

3) Dose, Dosing regimen, Dosing period
(1) Dose, Dosing regimen
Subjects take Dangguijakyaksan provided twice a day, one packet at a time, orally before meals in the morning and at night.

(2) Dosing period
The dosing period is from the evening of Visit 1 to the morning of Visit 3, and since the visit is determined according to the menstrual cycle of each subject, the period may be different.

Arm Label

Target Number of Participant

Arm Type

Arm Description

1) Information on investigational drugs
Kracie Dangguijakyaksan, 3g/1pack

2) schedule
[Visit 1]
Subjects visit Hospital on the 3rd day of their first menstruation after screening, receive and take 40 days of Dangguijakyaksan.
[Visit 2]
Subjects visit Hospital on the 3rd day of the second menstruation, and return the remaining Dangguijakyaksan, provided at visit 1, along with the packaging, and receive another 40-day supply of Dangguijakyaksan. 
[Visit 3]
Subjects visit Hospital on the 3rd day of their third menstruation, and perform the examination and sample collection scheduled for visit 3. 

3) Dose, Dosing regimen, Dosing period
(1) Dose, Dosing regimen
Subjects take Dangguijakyaksan provided twice a day, one packet at a time, orally before meals in the morning and at night.

(2) Dosing period
The dosing period is from the evening of Visit 1 to the morning of Visit 3, and since the visit is determined according to the menstrual cycle of each subject, the period may be different.

Gender

Age

Description

1) Women of childbearing age over 19
2) Those who are within 20% of the ideal weight calculated by Broca's formula
3) Those with regular menstrual cycles (within 28 days ± 7 days)
4) Those who complain of primary dysmenorrhea with mild (visual analog scale (VAS) less than 40mm) for at least 6 months during screening
5) Medically without congenital or chronic disease
6) Those who are judged to be suitable for the subject through medical examination (typical items such as interview, blood pressure, physical examination, blood test, blood chemistry test, urine test, serum test, etc.)
7) Among applicants who are highly likely to become pregnant, those who are not pregnant by the pregnancy test at the time of medical examination, and those who use medically acceptable contraception other than hormonal contraception until the end of the study
8) Applicants who can participate in the entire clinical trial process
9) A person who has fully explained the purpose, content, and drug of the clinical trial for this clinical trial, and a person who decides to participate in the clinical trial and gives written consent.

1) Those who refuse written consent or do not have the ability to consent in writing
2) Pregnant or lactating women
3) Persons who use hormonal contraception among medically acceptable birth control methods (e.g., implanon, intrauterine device insertion (e.g., mirena), oral contraceptives)
4) Those who have undergone gastric acid secretion suppression surgery or gastric or esophageal surgery that may affect the absorption of clinical trial drugs (except for simple perforation, appendectomy, and cholecystectomy)
5) Those with gastrointestinal diseases (Crohn's disease, ulcers, acute/chronic pancreatitis) that may affect the absorption of investigational drugs
6) Those who have been diagnosed with clinically significant systemic diseases (liver, kidney, nervous system, respiratory system, cardiovascular system, urinary system, endocrine system), malignant tumor, or mental illness.
7) Those who fall under frequent menstruation (period less than 21 days) or rare menstruation (period exceeding 35 days)
8) Those who showed clinical abnormalities in the screening test, especially those who showed the following test results
Hemoglobin <11.0 g/dL
AST or ALT value exceeds 1.5 times the upper limit of the laboratory's normal range
Total bilirubin value exceeds 1.5 times the upper limit of the normal range of the laboratory
Serum creatinine level exceeds the upper limit of the laboratory's normal range
9) Those who took specialty medicines or herbal medicines within 10 days before screening, or who took general medicines or vitamin preparations within one week
10) Smokers (However, those who quit smoking at least 3 months before the start of the test are allowed)
11) Those who consume excessive alcohol (alcohol> 30g/day)
12) Those who have hypersensitivity to or a history of any medicinal materials or herbal medicines composed of Dangguijakyak-san
13) Those with genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.
14) Those who participated in other clinical trials within 3 months before screening and administered investigational drugs (participation is based on the last administration date of the investigational drug)
15) Those who received blood transfusion within 1 month before screening
16) When the investigator judges that the subject is not suitable for administration of Dangguijakyaksan due to Korean medicine theory
17) Those who have clinical findings other than the above, which the investigator considers to be medically inappropriate for this study

Changes in metabolites before and after taking Dangguijakyaksan

Visit 1, Visit 2, Visit 3

VAS, FSH, E2, Adverse event, laboratory tests, vital signs and physical examination

Visit 1, Visit 2, Visit 3