None listed
Conditions
Interventions
Medical Device : Local acupoint and distal acupoint light therapy, self-administered for 20 minutes daily over the 7 days preceding the onset of menstruation.
Sponsors
Korea Institute of Oriental Medicine
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) Women aged between 19 and 45 years. 2) Individuals who have consistently experienced primary dysmenorrhea (menstrual pain) over the past 3 months, with a menstrual pain VAS score of 40 mm or higher. 3) Individuals with a regular menstrual cycle ranging from 21 to 35 days (28 ± 7 days) over the past 3 months. 4) Individuals who have voluntarily provided written informed consent to participate in the clinical trial.
Exclusion criteria
Exclusion criteria: 1) History of major psychiatric disorders within the past 2 years, current use of psychotropic medications such as antidepressants, or suspected to have moderate-to-severe depression based on a Korean version of the Beck Depression Inventory-II (score = 23). 2) Use of oral contraceptives or other forms of hormone therapy within 3 months prior to the screening visit. 3) Presence of structural abnormalities that may cause dysmenorrhea (e.g., uterine fibroids, ovarian cysts, endometriosis, cervical stenosis). 4) History of treatment for uterine inflammatory conditions such as endometritis or cervicitis within 2 months prior to screening. 5) Known thyroid disease or abnormal thyroid function test at screening (TSH = 0.6 µIU/ml or TSH = 6.8 µIU/ml). 6) Use of an intrauterine contraceptive device (IUD). 7) Currently pregnant or breastfeeding, planning to become pregnant, or likely to become pregnant without use of medically acceptable contraception during the study period. 8) Severe hepatic or renal impairment, or abnormal laboratory findings at screening (AST or ALT = 2× the upper limit of normal [ULN]; BUN = 2× ULN; Creatinine = 2.0 mg/dL). 9) Diagnosis of malignancy within the past 5 years. 10) Hemoglobin level < 11 g/dL at screening, or currently undergoing treatment for anemia. 11) Uncontrolled hypertension (systolic BP = 180 mmHg or diastolic BP = 110 mmHg at screening). 12) Uncontrolled diabetes mellitus (HbA1c = 9% at screening). 13) Any uncontrolled serious systemic disorder or infectious disease, including but not limited to cardiovascular, respiratory, gastrointestinal, genitourinary, neurological/psychiatric, hematological, endocrine (e.g., hyperprolactinemia), or autoimmune diseases (e.g., systemic lupus erythematosus). 14) Known hypersensitivity or allergic reaction to the investigational medical device. 15) Inability to self-administer the investigational device as required due to compliance issues or other limitations. 16) Participation in another clinical trial involving investigational medical devices or drugs for pain relief within 3 months prior to the screening visit. 17) Deemed by the investigator to be unsuitable for the study for any other reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Visual analogue scale (VAS) of pain severity | — |
Secondary
| Measure | Time frame |
|---|---|
| Korean-Beck Depression Inventory-II (K-BDI-II);EQ-5D-5L (5-level EuroQol 5-dimensional questionnaire);Stress Response Inventory-Short Form (SRI-SF);State-Trait Anxiety Inventory (STAI);Patient Global Impression of Change (PGIC) | — |
Countries
Korea, Republic of
Contacts
Public ContactEun-Hee Lee
Woosuk University
Outcome results
None listed