Clinical study on the effect of Jinhong Wuji Baifeng Soft Capsule on the level of estrogen in patients with premature ovarian failure and climacteric syndrome

Phase 1

• Conditions: premature ovarian failure and climacteric syndrome

• Registration Number: ITMCTR2100005200
• Lead Sponsor: nion Hospital TongJi Medical College HuaZhong University Of Science And Technology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Pending
• Sex: Female
• Target Recruitment: Not specified

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 <185pmol/L, and at least 6 months of amenorrhea; patients with menopausal syndrome: menstrual disorders or Menopause for more than 3 months, FSH>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

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.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Serum estradiol (E2);

Secondary Outcome Measures

Name	Time	Method
uteinizing 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);