To evaluate the efficacy and safety of Kuntai capsule alone or combined with hormone therapy in improving ovarian function in POI patients (including subclinical stage).

The study is expected to be conducted between 2021.08 and 2023.12.120 subjects with early-onset ovarian insufficiency will be randomly assigned to trial, control, or combination groups using a computer-generated randomization table.By comparing the data of primary efficacy indexes, secondary efficacy indexes and safety indexes before and after medication, The principal investigator will write and publish the paper.

Inclusion Criteria:

1. The women aged <40 years old.
2. 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.
3. Individuals meeting the above criteria who voluntarily consented to study participation.

Exclusion Criteria:

1. Pregnant and lactating patients;
2. Patients with endometriosis, adenomyosis, endometrial lesions (submucous fibroids, endometrial polyps, etc.), hysteromyoma > 4cm or hysterectomy;
3. Patients with known or suspected breast cancer history and estrogen-dependent malignant tumor;
4. 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);
5. Patients with porphyria;
6. Patients with serious primary diseases or mental illness such as cardiovascular, liver, kidney and hematopoietic system;
7. Patients who are participating in other clinical trials or have participated in other clinical trials in the past three months;
8. Patients who suspect or have a history of alcohol and drug abuse;
9. Patients who are known to be allergic to the test drugs or their components;
10. The researchers determined that patients are not suitable for this trial.

Not planning sharing at present.

blind experiment