Clinical Observation on Kuntai Capsule in Treating Early-onset Ovarian Hypofunction
Primary Ovarian Insufficiency
About this trial
This is an interventional treatment trial for Primary Ovarian Insufficiency
Eligibility Criteria
Inclusion Criteria:
- The women aged <40 years old.
- Serum basal follicle stimulating hormone (FSH) level ≥15 IU/L at least twice inspection (two occasions >4 weeks apart). Rare menstruation or menopause for at least 4 months.
- Individuals meeting the above criteria who voluntarily consented to study participation.
Exclusion Criteria:
- Pregnant and lactating patients;
- Patients with endometriosis, adenomyosis, endometrial lesions (submucous fibroids, endometrial polyps, etc.), hysteromyoma > 4cm or hysterectomy;
- Patients with known or suspected breast cancer history and estrogen-dependent malignant tumor;
- Patients with personal history of venous thromboembolism (VTE) or high risk of VTE (including body mass index > 30 kg/m2, smoking and family history of thrombosis);
- Patients with porphyria;
- Patients with serious primary diseases or mental illness such as cardiovascular, liver, kidney and hematopoietic system;
- Patients who are participating in other clinical trials or have participated in other clinical trials in the past three months;
- Patients who suspect or have a history of alcohol and drug abuse;
- Patients who are known to be allergic to the test drugs or their components;
- The researchers determined that patients are not suitable for this trial.
Sites / Locations
- Hai'an People's HospitalRecruiting
- Hai'an Hospital of traditional Chinese MedicineRecruiting
- Nantong First People's HospitalRecruiting
- Nantong Hospital of Traditional Chinese MedicineRecruiting
- Affiliated Hospital of Nantong UniversityRecruiting
- Rugao Boai HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Active Comparator
Experimental
Experimental
POI patients who taking Kuntai capsule
POI patients who accepting hormone therapy
POI patients who taking Kuntai capsule combined with hormone therapy
Subclinical POI patients who taking Kuntai capsule
Patients in this group will take Kuntai capsule orally, 4 capsules each time, 3 times a day, and take the medicine for 3 courses.
The estrogen and progesterone sequential regimen was adopted. The drug was estradiol tablets/estradiol didroxyprogesterone tablets (Femoston). Red tablets (estradiol, 2mg/d) were taken in the first 14 days, and gray tablets (estradiol, 2mg/d, dydrogesterone,10 mg/d) were taken in the last 14 days. 28 days was a course of treatment, and 3 courses of treatment were taken.
Kuntai capsule was taken at the same dose as Kuntai group on the basis of hormone therapy for 3 courses.
Subclinical POI patients in this group which with Kuntai capsule intervention. This group is a self-controlled experiment before and after treatment