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
- Conditions
- PMS
- Registration Number
- ITMCTR2200005676
- Lead Sponsor
- Peking University Third Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Female
- Target Recruitment
- Not specified
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.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method DRSP score;
- Secondary Outcome Measures
Name Time Method 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 ;