Female menopause-related diseases
Conditions
Interventions
Sponsors
Guangdong Provincial Hospital of Chinese Medicine
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Patients who meet the following diagnostic criteria: Premature ovarian insufficiency (POI) (1) Aged 25U / L (interval > 4 weeks); (4) In subclinical stage, the level of POI: FSH is 15-25 U / L, which is a high-risk group. Diagnostic criteria of Western medicine for menopausal syndrome (PMS) (1) 40 = 7 days, or the menstrual cycle >= 60 days, and the blood FSH >= 25U / L. TCM syndrome standard: (1) Main symptoms: delayed menstrual cycle, sore waist and knees, abnormal emotions (emotional depression, irritability); (2) Secondary symptoms: sweating, chest distress and sigh, poor sleep; (3) The tongue is dull with thin yellow coating and thin vein. 2. The score of SAS and SDS was >= 62 (standard score). 3. According to DSM-V, patients with depression and / or anxiety disorders were diagnosed, and the symptoms lasted for at least 30 days before screening; the depression / anxiety symptoms appeared in the menopausal transition period; and the depression / anxiety symptoms could not be explained by other physical and mental diseases. 4. Patients who have not used hormone therapy, selective estrogen receptor modulator or aromatase inhibitor, soybean extract or herbal medicine in the past three months; 5.18 < BMI< 24; 6. Patients who are willing and able to sign informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients with the following history of gynecological pelvic surgery: ovarian cyst exfoliation, ovarian perforation, ovarian wedge resection, appendectomy, salpingectomy, tubal ligation, pelvic abscess surgery, uterine artery embolization, etc.; or those who have used reproductive toxic drugs, such as Lei gongteng, Kunming Begonia, torch flower root tablet, chemotherapy drugs, etc. 2. Patients with a family history of premature ovarian failure or premature ovarian failure or other endocrine disorders such as hyperprolactinemia, polycystic ovarian syndrome and thyroid disease; 3. Those who have a history of habitual use of antibiotics or have used antibiotics, probiotics, prebiotics, microecological live bacteria preparations, cathartic or other drugs that affect gastrointestinal function in the past 1 month; 4. Patients with breast, digestive tract, reproductive tract cancer and gastrointestinal dysfunction (such as acute and chronic enteritis, constipation, diarrhea, Crohn's syndrome); 5. Patients who have recently had fertility requirements or pregnant or lactating women; 6. Patients with severe liver, kidney, heart and brain diseases; patients with uncontrolled or untreated hypertension (systolic blood pressure > 160mmhg and / or diastolic blood pressure > 100mmhg), uncontrolled or untreated diabetes mellitus; or patients with PTH abnormalities that may cause similar symptoms to POI; 7. Those with suicidal tendencies; 8. Patients with some allergic diseases such as asthma.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Greene scale;SDS scale;SAS scale;HAMA scale;HAMD scale; | — |
Secondary
| Measure | Time frame |
|---|---|
| Plasma metabonomics;Fecal metabonomics;Cranial fMRI; | — |
Countries
China
Contacts
Public ContactXiaoyun Wang
Guangdong Hospital of Traditional Chinese Medicine
Outcome results
None listed