premature ovarian failure and climacteric syndrome
Conditions
Interventions
single group:The selected subjects take the study drug Jinhong Wuji Baifeng Soft Capsule every day, 3 capsules (0.6g/capsule) each time, 3 times a day (1 time each in the morning, noon, and evening) f
Sponsors
Union Hospital TongJi Medical College HuaZhong University Of Science And Technology
Eligibility
Sex/Gender
Female
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: Subjects who meet all the following selection criteria can be included in this study: 1) Women aged 18-40 (including 18 years old) who are diagnosed with premature ovarian failure, or women aged 40-55 (including 40 and 55 years old) who are diagnosed with menopausal syndrome; 2) Patients with premature ovarian failure: In two tests with an interval of more than 1 month, serum FSH> 40 IU/L, E2 10 IU/L, and modified Kupperman score =16 points; 3) Have a detailed understanding of the nature, significance, possible benefits and possible inconvenience and potential dangers of the trial before the trial, and voluntarily participate in this clinical trial, can communicate well with the investigator, comply with the requirements of the entire study, and sign A written informed consent form was obtained.
Exclusion criteria
Exclusion criteria: Subjects who meet one or more of the following criteria will be excluded: 1) Participated in other drug clinical trials within 3 months; 2) (Inquiry) Diseases with abnormal clinical manifestations that need to be excluded, including but not limited to nervous system, cardiovascular system, blood and lymphatic system, immune system, kidney, liver, gastrointestinal tract, respiratory system, metabolism and bone systems People with diseases, and the investigator believes that these diseases may affect the results or safety of subjects participating in the study; 3) (Inquiry) Those with thrombotic disease, severe liver and kidney dysfunction; 4) (Inquiry) Patients with estrogen-dependent malignant tumors such as breast cancer, ovarian cancer, and endometrial cancer; 5) (Inquiry) Patients with bilateral ovarian resection and gynecological organic disease (hysteromyoma tumors larger than 2cm) and severe breast hyperplasia; 6) The results of vaginal B-ultrasound and breast B-ultrasonography are judged by clinicians as abnormal and clinically significant; 7) (Inquiry) Those who have received hormone replacement therapy (HRT) medications within 3 months, or health products with estrogen effects, Chinese patent medicines, Chinese medicines (royal jelly, soybean isoflavones, motherwort granules, Wuji Baifeng pills, Ziheche, Xiaoyao Pills, Kunbao Pills, Eucommia, Pueraria lobata, Angelica, Motherwort, Houttuynia cordata, Lysimachia, Scutellaria, etc.) healer; 8) (Inquiry) Those who have a history of specific allergies (asthma, urticaria, eczema, etc.), or those who are allergic to any medicine, food or pollen, or who are known to be allergic to Jinhong? Wuji Baifeng Soft Capsules; 9) (Inquiry) Subjects who have a childbirth plan or egg donation plan during the trial period to 3 months after the last dose, and are unwilling or fail to take effective contraceptive measures; 10) General physical examination, laboratory examination (blood routine, urine routine, liver and kidney function, pregnancy test, etc.) within 7 days before the test, ECG within 14 days before the test, and chest X-ray results within 6 months before the test are judged to be abnormal by the clinician Have clinical significance; 11) (Inquiry) Those who cannot eat or have difficulty swallowing; 12) (Inquiry) Those who have a history of asthma, epileptic seizures, or mental illness; 13) The investigator believes that the compliance is poor, or subjects who have any factors that are not suitable for participating in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum estradiol (E2); | — |
Secondary
| Measure | Time frame |
|---|---|
| Luteinizing hormone (LH);Serum Follicle Stimulating Hormone (FSH);Ovarian size and follicle number on both sides;Endometrial thickness;Improvement of the severity of clinical symptoms in patients (compared with modified Kupperman score); | — |
Countries
China
Contacts
Public ContactLi Weiyong
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Outcome results
None listed