premature ovarian insufficiency
Conditions
Interventions
Trial group:Tian Jing Formula + Femoston
Control group:Tian Jing Formula simulant+ Femoston
Sponsors
Longhua Hospital,Shanghai University of Traditional Chinese Medicine
Eligibility
Sex/Gender
Female
Age
18 Years to 40 Years
Inclusion criteria
Inclusion criteria: (1) Consistent with the diagnosis of premature ovarian insufficiency; (2) Consistent with the diagnosis of kidney deficiency type of Chinese medicine; (3) Age 18 to 40 years (including 18 and 40 years) (4) Serum follicle stimulating hormone >15 U/L at baseline; (5) Contraception during drug administration; (6) Voluntarily participated in this clinical trial, gave informed consent and signed an informed consent form.
Exclusion criteria
Exclusion criteria: (1) Amenorrhea or scanty menstruation caused by congenital abnormalities of genital organ development, acquired organic lesions and injuries of the genital organs, and hypothalamic/pituitary lesions; (2) Combination of other endocrine or metabolic-immune disorders that affect ovarian function, such as polycystic ovary syndrome, hyperprolactinemia, hyperandrogenemia, thyroid dysfunction, functional hypothalamic amenorrhea, and ovarian resistance syndrome; (3) Early onset ovarian insufficiency caused by chromosomal abnormality or gene mutation, or medical factors (radiotherapy, chemotherapy); (4) Received hormonal or herbal medication, non-hormonal medication with therapeutic effect on the disease, or non-pharmacological treatment (e.g., acupuncture, external application, enema, etc.) within the past month; (5) Pregnant and lactating women or those who plan to have children within six months; (6) ALT or AST =1.5 times the upper limit of the normal reference value or Scr > upper limit of the normal reference value; (7) Mental retardation or mental illness or neurosis; (8) Combination of serious primary diseases of the heart, brain, lung, liver, kidney, endocrine, nervous system and hematopoietic system; (9) Combination of known breast ultrasound BI-RADS rating = 3 and uterine fibroids > 4 cm; (10) Combined estrogen-dependent tumors (e.g., breast cancer, endometrial cancer, etc.); (11) Contraindications to estrogen-progestin use; (12) Known or suspected risk of arterial thrombosis; (13) Suspected or confirmed history of alcohol or drug abuse; (14) Known or suspected history of allergy to components of the test drug; (15) Participation in other clinical trials in the last 3 months; (16) In the opinion of the investigator, participation in this clinical trial is inappropriate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Follicle stimulating hormone; | — |
Secondary
| Measure | Time frame |
|---|---|
| Luteinizing hormone;Estradiol; anti-Müllerian hormone;Antral follicle count; ovarian arterial/venous blood flow;ovulation rate;Improved Kupperman scores;Chinese Medicine Symptom Score;Serum tumor necrosis factor;Serum interleukin-1ß;tongue image;Serological tests; | — |
Countries
China
Contacts
Public ContactXu Lianwei
Longhua Hospital,Shanghai University of Traditional Chinese Medicine
Outcome results
None listed