Premenstrual syndrome
Conditions
Interventions
Experimental group:Jingqianshu granules
Control group:Jingqianshu granule simulator
Sponsors
Hebei University of Traditional Chinese Medicine
Eligibility
Sex/Gender
Female
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Women aged 18-45 years (including 18 and 45); 2. Consistent with the diagnosis of premenstrual syndrome (PMS); 3. Syndrome differentiation of TCM is liver depression and qi stagnation; 4. Regular menstruation within the past 12 months, with menstrual cycles ranging from 21 to 35 days (including 21 and 35 days); 5. Subjects understand and voluntarily participate in this study and sign informed consent.
Exclusion criteria
Exclusion criteria: 1. B ultrasound (transabdominal) of the adrenal uterus suggests that it is not appropriate to participate in clinical studies, including but not limited to ovarian cyst >=5cm, uterine fibroids >=4cm, or suspected malignant tumors of the reproductive system; 2. Patients who are pregnant or plan to have a pregnancy within the first 6 months, patients who are lactating or within 3 months after the end of lactating; 3. Patients assessed by doctors to be in a state of severe anxiety, depression, or suicidal intention; 4. Patients diagnosed with schizophrenia, bipolar disorder, anxiety disorder, depression and other mental diseases or combined with somatization disorder; 5. Have injected sex hormone preparations, resistance hormone preparations and other drugs affecting sex hormones in the past 6 months or taken in the past 3 months; Used nerve blockers, antidepressants, antianxiety, antipsychotics and other psychiatric drugs in the past 3 months; Those who have certain medical conditions and need to receive the above treatment during the trial period of nearly 6 months; 6. Those who must and can only use instrumental contraception (without sex hormones) during the test period, for which they cannot accept or cannot strictly use contraception; 7. Complicated with cardiovascular and cerebrovascular diseases, liver, kidney, hematopoietic system, endocrine system and other serious primary diseases; 8. Allergic constitution, and allergy or intolerance to known ingredients and excipients of the drug in this study; 9. Suspected or confirmed history of alcohol and drug abuse; 10. Participated in or is participating in other clinical trials within the last 3 months; 11. The researcher judged that there were other conditions that were not suitable for participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change of premenstrual symptom severity scale score (DRSP score) after 3 menstrual cycles of treatment compared with that before treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes of single symptom index scores after treatment;Changes of TCM syndrome score; | — |
Countries
China
Contacts
Public ContactDu Huilan
Outcome results
None listed