None listed
Conditions
Interventions
Drug : 1. Experimental group: Gamisoyo-san (Orally administered, 1 packet (3g) twice a day, for 3 menstrual cycles (approximately 12 weeks) + Usual Care
2. Control group: Usual Care
Sponsors
Daejeon Korean Medicine Hospital of Daejeon University
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) Female aged 19 to 45 years. 2) Participants who have consistently experienced primary dysmenorrhea (menstrual pain) in the past three months, with a Visual Analogue Scale (VAS) score of 40 mm or higher. 3) Participants who have consistently experienced premenstrual syndrome over the past three months and meet the following criteria during the most recent menstrual cycle at the time of Visit 1 and one menstrual cycle during the screening period: -Meet the diagnostic criteria for premenstrual syndrome by the American College of Obstetricians and Gynecologists (ACOG). -Score at or above the threshold for moderate to severe PMS on the Premenstrual Symptoms Screening Tool (PSST). 4) Participants with a regular menstrual cycle ranging from 21 to 35 days (28±7 days) over the past three months. 5) Participants who have voluntarily given written consent to participate in the clinical trial.
Exclusion criteria
Exclusion criteria: 1) Participants with a history of major psychiatric disorders within the past two years, those currently taking psychotropic medications such as antidepressants, or those suspected of having major depressive disorder, panic disorder, generalized anxiety disorder, bulimia nervosa, binge-eating disorder, or alcohol use disorder based on the Patient Health Questionnaire (PHQ). 2) Those who have taken oral contraceptives or undergone female hormone therapy within the last three months, or those who have taken products containing Agnus Castus or traditional herbal medicines for menstrual pain and premenstrual syndrome within one month prior to screening. 3) Participants diagnosed with intra-pelvic lesions such as uterine fibroids, adenomyosis, endometriosis, or pelvic inflammatory disease. 4) Those with thyroid diseases or abnormal thyroid function test results at screening (TSH = 0.6 µIU/ml or TSH = 6.8 µIU/ml). 5) Participants currently using an intrauterine device. 6) Pregnant or breastfeeding participants, or those not using a medically acceptable method of contraception during the trial. 7) Participants with severe liver or kidney disorders, or those with AST, ALT = twice the upper limit of normal, BUN = twice the upper limit of normal, or Creatinine = 2.0 mg/dl at screening. 8) Those diagnosed with a malignant tumor within the past five years. 9) Participants with a hemoglobin level less than 11 g/dL at screening or diagnosed with and treated for anemia. 10) Those with uncontrolled hypertension (systolic blood pressure = 180 mmHg or diastolic blood pressure = 110 mmHg at screening). 11) Participants with uncontrolled diabetes (HbA1c = 9% or fasting glucose = 160 mg/dL at screening). 12) Those with uncontrolled serious systemic diseases including cardiovascular, respiratory, gastrointestinal, genitourinary, neurological/psychiatric, hematological disorders, endocrine disorders (e.g., hyperprolactinemia), autoimmune diseases (e.g., systemic lupus erythematosus), or severe infectious diseases. 13) Participants with galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption. 14) Participants with known hypersensitivity to the investigational medicinal product. 15) Those who have participated in another clinical trial and received an investigational drug within three months prior to the screening visit. 16) Participants who don't record the dysmenorrhea symptom diary or whose menstrual pain VAS score is less than 40 mm preceding the baseline visit. 17) Participants deemed unable to participate in the clinical trial for other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in menstrual pain intensity measured by the visual analogue scale (VAS) | — |
Secondary
| Measure | Time frame |
|---|---|
| Pain duration for one menstrual cycle;Consumption of painkiller for one menstrual cycle;Daily Record of Severity of Problems (DRSP);Premenstrual Symptoms Screening Tool (PSST);EQ-5D-5L;Patients’ Global Impression of Change, PGIC | — |
Countries
Korea, Republic of
Contacts
Public ContactPyung-Wha Kim
Korea Institute of Oriental Medicine
Outcome results
None listed