premenstrual syndrome
Conditions
Interventions
Experimental group:Jiawei Xiaoyao Wan
Sponsors
Dongzhimen Hospital Beijing Univercity of Chinese Medicine
Eligibility
Sex/Gender
Female
Age
18 Years to 40 Years
Inclusion criteria
Inclusion criteria: 1. Both the two menstrual cycles during the induction period are consistent with the diagnostic criteria of Western medicine for premenstrual syndrome, ie, DRSP of luteal phase is >50 points, and the luteal phase DRSP score increased =30% with the follicular phase, and at least 3 symptom scores of DRSP were >3 points; 2. Mild to moderate PMS (mild PMS definition: PMS psychological/physical symptoms do not affect personal, social and work, ie the dysfunction score in the DRSP scale is 0 points; moderate PMS definition: PMS psychology / Physical symptoms affect personal, social, and work, that is, the dysfunction score in the DRSP scale is =1, but there is no withdrawal symptom after stopping the drug); 3. Meet the liver depression, spleen deficiency and blood heat TCM syndrome; 4. Menstrual regularity, cycle frequency are normal(= 21 and = 35 days); 5. female aged 18 to 40 years; 6. HAMD17 scores 7 to 17; 7. voluntarily to participate in the trial and have signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Any medication for the treatment of PMS is used within 3 months prior to the screening period, including but not limited to hormones, bromocriptine, gonadotropin-releasing hormone agonists, vitamin B (>100 mg/d), calcium (>1500 mg/ d), neuroleptics, anti-anxiety and antidepressants, serotonin reuptake inhibitors and other drugs; 2. Depreesion was more than 3 in HAMD17; 3. Suiside was more than 2 in HAMD17; 4. Planned gynecological or breast surgery recently; 5. Patients with genital tract inflammation and need to take treatment measures, or gynecological tumors, or breast disease with abnormal mass (ie, non-blocky breast diseases such as breast lobular hyperplasia, breast nodules, etc.); 6. Patients with severe primary diseases such as heart, brain, liver, kidney and hematopoietic system, including ALT, AST > 1.5 times the upper limit of normal, Cr > normal upper limit; 7. Patients with a history of mental illness; 8. Pregnant, lactating women or those who have a birth plan during the trial; 9. Those who are allergic to the test drug composition are known; 10. Those who have participated in other clinical trials within 3 months before this trial; 11. Researchers recognized anyone who not suitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The luteal phase DRSP scores reduced value with the baseline after 3 menstrual cycle,;The changes of TCM syndrome scores and single TCM symptoms at the end of 1, 2, 3 menstrual cycles.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Compare the luteal phase DRSP decline value with the baseline at the end of 1, 2 menstrual cycles.;Compare the changes of DRSP scores between luteal phase and follicular phase at the end of 1, 2, and 3 menstrual cycles.;Return to normal patient percentage at the end of 1,2,3 menstrual cycles.;The psychological/physical symptom scores in DRSP decreased from baseline at the end of 1, 2, 3 menstrual cycles.;The dysfunction scores in DRSP decreased from baseline at the end of 1, 2, 3 menstrual cycles.; | — |
Countries
China
Contacts
Public ContactHongkai Li
Dongzhimen Hospital Beijing Univercity of Chinese Medicine
Outcome results
None listed