PMS
Conditions
Interventions
experimental group:safflower Xiaoyao tablets
comparison group:Xiaoyao Pill
Sponsors
Peking University Third Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: Inclusive criteria for a qualified subject, the answer to all inclusion criteria must be "yes". (1) Those who meet the diagnostic criteria of PMS western medicine; (2) Those who meet the diagnostic criteria of liver depression and qi stagnation syndrome in traditional Chinese medicine; (3) The total score of daily record scale (DRSP) of symptom severity 5 days before menstruation (luteal phase) is more than 50, and the scores of at least three symptoms in DRSP are more than 3; (4) 22 days = menstrual cycle = 42 days; (5) 18 years = age < 45 years; (6) The patient gave informed consent and signed the informed consent form.
Exclusion criteria
Exclusion criteria: For a qualified subject, the answer to all exclusion criteria must be "no": (1) patients with previously diagnosed diseases such as breast tumor, malignant tumor of reproductive system, polycystic ovary syndrome, hyperprolactinemia, ovarian hypofunction, ovarian cyst, early-onset ovarian insufficiency, premature ovarian failure, hyperthyroidism or hypothyroidism; (2) Previously diagnosed with schizophrenia, anxiety disorder, depression and other mental diseases; (3) Patients with sleep disorders requiring medication; (4) Patients with severe primary diseases such as heart, brain, liver, kidney and hematopoietic system, in which ALT and AST > 2.0 times the upper limit of normal value and Cr > the upper limit of normal value; (5) Patients with hemorrhagic diseases; (6) Pregnant or planned pregnancy, lactating women; (7) Those who are allergic to the drug components in the known test drug; (8) Participate in other relevant clinical studies within 1 month before enrollment; (9) The researchers did not consider it suitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| DRSP score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes of five items of sex hormones (FSH, LH, E2, PRL, t) ;Curative effect of single TCM symptom ;PBAC score change value of menstrual blood loss map ;Effective rate of TCM Syndrome ; | — |
Countries
China
Contacts
Public ContactRong Li
Outcome results
None listed