None listed
Conditions
Interventions
Drug : 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
Sponsors
Daegu Haany University
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in metabolites before and after taking Dangguijakyaksan | — |
Secondary
| Measure | Time frame |
|---|---|
| VAS, FSH, E2, Adverse event, laboratory tests, vital signs and physical examination | — |
Countries
Korea, Republic of
Contacts
Public ContactSoo-Jin Park
Daegu Haany University
Outcome results
None listed