primary dysmenorrhea
Conditions
Interventions
Experimental group:Take 3g of the new prepared Guizhi Fuling Pill extract without decoction one week before menstruation and three days before the onset of menstruation. Continue for 10 consecutive da
Control group:Placebo granules were taken for 10 consecutive days each menstrual cycle, starting from one week before menstruation and the first three days of menstruation, for three consecutive menst
Sponsors
Yichang Maternal and Child Health Care Hospital
Eligibility
Sex/Gender
Female
Age
15 Years to 35 Years
Inclusion criteria
Inclusion criteria: (1) Meets the diagnostic criteria for PDM and the type of damp-heat and blood stasis syndrome; (2) Age 15-35 years old; (3) Menstrual cycle (28±7) days; (4) In the 1-month menstrual cycle prior to receiving this therapy no other treatment was received and within 2 weeks before the treatment no sedative drugs analgesics or hormone drugs were taken; (5) Signed the informed consent form and voluntarily participated in this study. Note: Only patients who meet all 5 of the above criteria can be included in this study.
Exclusion criteria
Exclusion criteria: Patients cannot be enrolled in the study if any of the following conditions apply: (1) Patients with secondary dysmenorrhea due to uterine fibroids, adenomyosis, endometriosis, pelvic inflammatory disease, etc. (2) Women in the preconception period, pregnancy, or lactation. (3) Patients currently using drugs with similar effects to the investigational drug. (4) Patients with a history of low back pain. (5) Patients with severe primary diseases such as cardiovascular, cerebrovascular, liver, kidney, and hematopoietic system diseases. (6) Patients with mental disorders or intellectual disabilities who cannot cooperate with the questionnaire survey. (7) Patients with severe claustrophobia, pacemakers, or ferromagnetic implants in the body, which are contraindications for MRI. (8) Patients with a score of = 50 on the Self-Rating Anxiety Scale [28] or the Self-Rating Depression Scale [29]. (9) Patients who have used analgesics or sedatives within 2 weeks before enrollment. (10) Patients participating in multiple clinical trials simultaneously. (11) Patients who refuse to sign the informed consent form.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain intensity; | — |
Secondary
| Measure | Time frame |
|---|---|
| Emotional state;Symptoms of dysmenorrhea and associated symptoms; | — |
Countries
China
Contacts
Public ContactNie Chen
Yichang Maternal and Child Health Care Hospital
Outcome results
None listed