perimenopausal syndrome
Conditions
Interventions
Control group: Fufang Muniziqi Keli placebo + Gengnian'an Jiaonang:Fufang Muniziqi Keli placebo:6 g/dose, 3 times/day, orally
Gengnian'an Jiaonang:3 capsules/dose, 3 times/day, orally
Trial group: Fufang Muniziqi Keli + Gengnian'an Jiaonang placebo:Fufang Muniziqi Keli:6 g/dose, 3 times/day, orally
Gengnian'an Jiaonang placebo:3 capsules/dose, 3 times/day, orally
Sponsors
Beijing Hospital of Traditional Chinese Medicine, Capital Medical University
Eligibility
Sex/Gender
Female
Age
40 Years to 60 Years
Inclusion criteria
Inclusion criteria: Subjects must meet all of the following enrollment criteria to be enrolled in this trial: (1) Compliance with the Western medical diagnosis of perimenopausal syndrome; (2) Compliance with the Chinese medical diagnosis of kidney yin deficiency; (3) A modified Kupperman scale score of 7 to 30 (including boundary values); (4) Women aged 40 to 60 years (both ends included); (5) Voluntarily participated in this clinical trial, gave informed consent and signed a written informed consent form.
Exclusion criteria
Exclusion criteria: Subjects with any of the following are not eligible for enrollment in this study: (1) Being in late menopause (from last menstrual period) for more than 2 years; (2) Have used sex hormone analogs affecting ovarian function prior to screening and have not reached the washout period since discontinuation: (1) Discontinued transvaginal hormonal products (rings, creams or gels) for less than 1 week; 2) Discontinuation of transdermal estrogen or estrogen/progesterone-based preparations for less than 4 weeks; 3) Cessation of oral estrogen and/or progestin therapy for less than 8 weeks; 4) Cessation of intrauterine progestin therapy for less than 8 weeks; 5) Cessation of progestin implants and estrogen injection therapy alone for less than 3 months; (6) Cessation of estrogen burial or progestin injection therapy for less than 6 months. (3) Have taken herbal or botanical medications (e.g.,Xiangshao Keli, livermint, etc., or similar medications), or psychotropic medications (selective 5-hydroxytryptamine reuptake inhibitors, 5-hydroxytryptamine norepinephrine reuptake inhibitors, and monoamine oxidase inhibitors) that may affect the evaluation of efficacy within 4 weeks prior to the screening visit or have used tamoxifen, toremifene, raloxifene, or any other selective estrogen receptor modulators or aromatase inhibitors; (4) Artificial menopause (bilateral oophorectomy, hysterectomy, destruction of ovarian function by radiotherapy, etc.), untreated unexplained irregular vaginal bleeding, endometrial polyps > 1.5 cm, endometrial (double-layer) thickness = 0.5 cm on ultrasound in the late menopausal stage (except for those without endometrial pathology detected by diagnostic curettage or hysteroscopy), uterine fibroids with a diameter of the largest uterine fibroid > 3.0 cm, or submucosal fibroid, or diagnosed or suspected sub-mucous uterine fibroid. Fibroid, confirmed or suspected pre-cancerous lesions (e.g. endometrial atypical hyperplasia/endometrial intraepithelial neoplasia, etc.) or malignant tumors of the uterus and its adnexa; (5) Predisposition to breast malignancy (BI-RADS rating = grade 4), or confirmed breast malignancy; (6) Pelvic tuberculosis or purulent pelvic inflammatory disease, or planned pelvic surgery during the trial; (7) Comorbidities with severe cardiovascular, hepatic, renal, neurological, hematopoietic, or malignant neoplastic diseases, or psychiatric disorders that, in the judgment of the investigator, require the administration of medication for antidepressant or anxiolytic treatment, which may affect the judgment of efficacy and safety; (8) Combined hypertension but poorly controlled blood pressure (systolic blood pressure =160 mmHg and/or diastolic blood pressure =100 mmHg) despite standardized treatment with medication and possible hypertensive crisis, or poorly controlled hypotension (systolic blood pressure =90 mmHg and/or diastolic blood pressure =60 mmHg); (9) Combined diabetes mellitus or poor glycemic control with glycated hemoglobin (HbA1c) = 7.0%; (10) Combined hyperthyroidism, hepatitis or history of pharmacologic liver injury; (11) Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) exceeding 1.5 times the upper limit of normal reference value, or blood creatinine (Scr) exceeding the upper limit of normal reference value; (12) Women who are pregnant, breastfeeding, or have a request for childbearing from the Screening Period to 3 months after discontinuation of the drug, or
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| At week 8 post-treatment,Modified Kupperman scale scores; | — |
Secondary
| Measure | Time frame |
|---|---|
| MENQOL scale scores;Zung Self-Assessment Scale for Anxiety (SAS);At week 4 week 8 and week 4 of follow-up after treatmentModified Kupperman scale scores;Hot flashes and sweating episodes;Chinese Medicine Symptom Score; | — |
Countries
China
Contacts
Public ContactXiu Xiang Teng
Beijing Hospital of Traditional Chinese Medicine Capital Medical University
Outcome results
None listed