Menopausal Syndrome
Conditions
Interventions
experimental group:Fenomentone tablet+ Baoqing granules
control group:Fenmortone tablet + Baoqing granules placeb
Sponsors
The Affiliated Traditional Chinese Medicine Hospital of Southwest Medical University
Eligibility
Sex/Gender
Female
Age
40 Years to 55 Years
Inclusion criteria
Inclusion criteria: (1) meeting the Western diagnostic criteria for menopausal syndrome; (2) The Traditional Chinese Medicine diagnosis is kidney yin deficiency syndrome; (3) 40 years old = age = 55 years old; (4) Modified Kupperman scores >15; (5) Follicle stimulating hormone (FSH) >10 U/L and endometrial thickness on ultrasound <5mm (single layer); (6) No contraindications to fenomentone treatment; (7) The study subjects voluntarily signed the informed consent form.
Exclusion criteria
Exclusion criteria: (1) Those who are allergic to any of the components of this trial drug; (2) Those who have participated in other clinical studies within three months and are taking medication; (3) have used sex hormone drugs or drugs for menopausal syndrome or health care products (such as antidepressants, sleep improvement drugs, etc.) within the last three months; (4) have serious diseases of the cardiovascular, cerebrovascular, hematopoietic system and internal organs such as liver and kidney; (5) People with mental illness and alcohol or drug dependence (sex hormone dependence); (6) Bilateral oophorectomy (except for patients under 40 years old after removal of benign ovarian tumors), ovarian tumors and premature ovarian failure; (7) Patients with malignant tumors or related medical history, such as breast cancer, endometrial cancer, meningioma; (8) Patients with hyperthyroidism and porphyria; (9) Patients with spinal disorders; (10) Patients with hepatic or renal insufficiency, unexplained vaginal bleeding, and untreated hyperplasia of the endometrium; (11) Patients with previous idiopathic or existing venous thromboembolism (deep vein embolism, pulmonary embolism); active or recent arterial thromboembolic disease (e.g., angina pectoris, myocardial infarction); (13) Other factors that, in the judgment of the investigator, make them unsuitable for participation in this clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Modified Kupperman score ;Traditional Chinese Medicine Symptom Score ; | — |
Secondary
| Measure | Time frame |
|---|---|
| Sex hormone levels (estradiol E2, follicle stimulating hormone FSH, luteinizing hormone LH) ;Safety indicators (vital signs, blood count, liver and kidney function, blood lipids, ECG,Adverse event rate) ;Menopausal Quality of Survival Scale (MENQOL) ;Depression Self-Rating Scale (SDS) ;Self-Assessment Scale for Anxiety ;Pittsburgh Sleep Quality Scale; | — |
Countries
China
Contacts
Public ContactYuan Yuan
The Affiliated Traditional Chinese Medicine Hospital of Southwest Medical University
Outcome results
None listed