Primary dysmenorrhea
Conditions
Interventions
group 1:First menstrual cycle: Start taking medication 1–2 days before menstruation begins, one capsule every 8 hours, for 3 consecutive days.
Second menstrual cycle: Take medication immediately at th
group 2:First menstrual cycle: Take medication immediately at the first sign of menstruation (before pain occurs), one capsule every 8 hours, for 3 consecutive days.
Second menstrual cycle: Take medic
group 3:First menstrual cycle: Take medication as needed when pain becomes unbearable. May take an additional dose 4 hours after the first dose if needed. Total daily dose should not exceed 900 mg.
Se
Sponsors
Peking University
Eligibility
Sex/Gender
Female
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Age 18 years or older, non-pregnant with a natural menstrual cycle; 2. Meet the diagnostic criteria for primary dysmenorrhea; 3. Regular menstrual cycle (menstrual cycle length of 21~35 days, with fluctuations not exceeding +/-3 days over three consecutive menstrual cycles); 4. No organic lesions or reproductive tract malformations as detected by gynecological ultrasound; 5. Previously required analgesics during menstruation, and the Visual Analog Scale (VAS) pain score for the most severe pain during the last recalled menstrual period was moderate or higher (VAS score >=4); 6. The subject understands the analgesic regimen of this trial and agrees to receive three different trial regimens over three consecutive menstrual cycles; 7. The subject is capable of understanding the pain assessment method and can use VAS scoring to express the degree of pain; 8. The subject voluntarily signs a written informed consent form.
Exclusion criteria
Exclusion criteria: 1. Pain symptoms in other areas; 2. Anti-inflammatory, antiallergic, or non-steroidal drug treatment within the past 14 days; 3. History of allergy to ibuprofen or other NSAIDs, or a history of asthma induced by NSAIDs; 4. Active peptic ulcer or severe gastrointestinal diseases such as a history of gastrointestinal bleeding; 5. Severe hepatic or renal insufficiency, coagulation dysfunction, or other serious chronic diseases that make participation in the trial inappropriate; 6. Concurrent mental disorders or neurological diseases that affect subjective pain assessment (e.g., severe depression, cognitive impairment, etc.); 7. Currently participating in other clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Difference in score of VAS peak 3 days before menstruation; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of gastrointestinal adverse reactions;Average duration of pain within 72 hours after the onset of menstruation;Cox Menstrual Symptom Scale;Self-Rating Depression Scale;Self-Rating Anxiety Scale;Richards–Campbell Sleep Questionnaire; | — |
Countries
China
Contacts
Public ContactXu Beibei
Peking University
Outcome results
None listed