premenstrual syndrome
Conditions
Interventions
experimental group:Honghua Xiaoyao tablets, taken orally, 4 tablets/time, 3 times/day, half an hour after meals
Xiaoyao Pill Simulator, 9g/time, twice a day, taken half an hour after breakfast and dinner.Take it continuously for 14 days (oral administration is started on the 14th day of menstrual cramps until t
control group:Honghua Xiaoyao Tablet Simulator, 4 tablets/time, 3 times/day, taken half an hour after meals
Xiaoyao Pill, 9g/time, twice a day, taken half an hour after breakfast and dinner.Take it continuously for 14 days (oral administration is started on the 14th day of menstrual cramps until the next me
Sponsors
Oriental Hospital of Beijing University of Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: (1)18 years old =45 years old; (2)22 days = menstrual cycle =42 days; (3) those who meet the diagnostic criteria of western medicine for premenstrual syndrome; (4) those who meet the diagnostic criteria of syndrome differentiation of liver depression and qi stagnation in traditional Chinese medicine; (5) The total score of the Daily Record Scale for Symptom Severity (DRSP) is more than 50, and at least 3 symptoms in DRSP are all more than 3.
Exclusion criteria
Exclusion criteria: (1) Patients with serious primary diseases such as heart, brain, liver, kidney and hematopoietic system, among which ALT, AST>2.0 times the upper limit of normal value and Scr>1.2 times the upper limit of normal value; Or previously diagnosed as schizophrenia, anxiety, depression and other mental illness patients; (2) Patients who have been diagnosed with breast tumor, malignant tumor of reproductive system, polycystic ovary syndrome, hysteromyoma (diameter =5cm), adenomyosis (moderate or severe), hyperprolactinemia, ovarian cyst (moderate or severe), early ovarian insufficiency, premature ovarian failure, hyperthyroidism or hypothyroidism; (3) Those who have taken oral contraceptives, hormones, vitamins and other drugs for PMS or dysfunctional uterine bleeding in the past month; (4) Pregnant women, pregnant women or lactating women; (5) Patients who are known to be allergic to the drugs used in this study and their related components; (6) Those who are participating in clinical trials of other drugs; (7) The researcher thinks it is not suitable for clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| After three menstrual cycles of treatment (visit 4), the changes of symptom severity daily record scale (DRSP) compared with the baseline period.; | — |
Secondary
| Measure | Time frame |
|---|---|
| After three menstrual cycles (visit 4), the effective rate of TCM syndrome was improved.;After three menstrual cycles of treatment (visit 4), the changes of curative effect index of single symptom compared with baseline period;Changes of five sex hormones (FSH, LH, E2, PRL, T) after three menstrual cycles (visit 4) compared with the baseline period.; | — |
Countries
China
Contacts
Public ContactQing Tong
Oriental Hospital of Beijing University of Chinese Medicine
Outcome results
None listed