Efficacy and safety of safflower Xiaoyao tablets in the treatment of Premenstrual syndrome (liver depression and qi stagnation syndrome): a multicenter, randomized, open, positive drug parallel controlled clinical trial

Peking University Third Hospital0 个研究点开始时间: 待定最近更新: 2023年2月20日

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•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.

•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.

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