Primary Dysmenorrhea
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1) Nulliparous women aged 15 to 30 years with primary dysmenorrhea (PD);2) Meeting the Western medical diagnostic criteria for primary dysmenorrhea;3) Conforming to the TCM diagnostic criteria for dysmenorrhea of the cold congelation and blood stasis pattern;4) Having a regular menstrual cycle (28±7 days);5) No organic pelvic lesions identified by pelvic examination, pelvic ultrasonography or laparoscopy;6) Suffering from persistent menstrual pain with a Visual Analogue Scale (VAS) score of =4;7) No analgesics taken within 24 hours prior to magnetic resonance imaging (MRI) scanning, no analgesics, sedatives or hormonal drugs administered within one week before treatment, and no oral contraceptives used within three months;8) Voluntarily participating in the clinical study and providing signed informed consent.
Exclusion criteria
Exclusion criteria: 1) Diagnosed with secondary dysmenorrhea or dysmenorrhea induced by intrauterine device (IUD) use;2) Pregnant or preconception women;3) A history of cardiovascular and cerebrovascular diseases or psychiatric disorders;4) With contraindications to functional magnetic resonance imaging (fMRI) scans;5) Hypersensitive to ibuprofen sustained-release capsules or with a history of severe adverse reactions to the drug;6) Alcohol or drug dependence.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Visual Analogue Scale; | — |
Secondary
| Measure | Time frame |
|---|---|
| Cox Menstrual Symptom Scale;Pittsburgh Sleep Quality Index;Brain Magnetic Resonance Imaging;Self-Rating Anxiety Scale;Self-Rating Depression Scale;TCM Syndrome Score; | — |
Countries
China
Contacts
Rehabilitation Hospital Affiliated to Fujian University of Traditional Chinese Medicine