Dysmenorrhea (menstrual pain) caused by blood stagnation Urological and Genital Diseases Pain and other conditions associated with female genital organs and menstrual cycle
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Female aged 18 to 35 years 2. Women with a period cycle of 30 ± 3 days during last 3 months 3. Women who have menstrual pain (dysmenorrhea) over 6 degrees by Visual Analogue Scale (VAS) 4. Women who are diagnosed with blood stagnation by two oriental medical gynaecologic specialists 5. Given written informed consent form 6. Given written informed consent form of genetic study
Exclusion criteria
Exclusion criteria: 1. Women who have major neuro-psychiatric disorder or have history of major neuro-psychiatric disorder (schizophrenia, epilepsy, alcohol abuse, anorexia etc) 2. Women who are planning to have baby or do not agree to use appropriate contraception (oral pill, hormone contraception, intrauterine device, condom etc) 3. Women who are taking anti-depressant, anti-serotonin barbiturate, psychotropic drugs
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain, assessed by Visual Analogue Scale (VAS), measured at screening, baseline and weeks 4, 8, 12 and 20 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Blood Stagnation Scale (based on Korean Medicine), measured at screening, baseline and weeks 4 and 8 2. Quantity of pain killer pills during period, recorded at screening, baseline and weeks 4, 8, 12 and 20 3. Short Form McGill Pain Questionnaire, measured at screening, baseline and weeks 4, 8, 12 and 20 4. Cox Menstrual Symptom Scale, measured at screening, baseline and weeks 4, 8, 12 and 20 5. Heart rate variability (HRV) outcome, measured at screening, baseline and weeks 4 and 8 | — |
Countries
Korea, South