premature ovarian insufficiency
Conditions
Interventions
Experimental group:2/10 mg Fenmetone + Chinese herbal granule Tian Jing formula
Control group:2/10 mg Fenmetone + placebo
Sponsors
Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Eligibility
Sex/Gender
Female
Age
18 Years to 40 Years
Inclusion criteria
Inclusion criteria: (1) Complies with the diagnosis of early-onset ovarian insufficiency; (2) Complies with the traditional Chinese medicine differentiation of kidney deficiency type; (3) Age range: 18-40 years old (including 18 and 40 years old) (4) At baseline serum follicle stimulating hormone levels were greater than 15U/L; (5) Contraception during medication period; (6) Voluntarily participate in this clinical trial provide informed consent and sign the informed consent form.
Exclusion criteria
Exclusion criteria: (1) Amenorrhea or infrequent menstruation caused by various diseases such as congenital reproductive organ developmental abnormalities acquired organic lesions and injuries of reproductive organs hypothalamic/pituitary lesions etc; (2) Merge other endocrine or metabolic immune system diseases that affect ovarian function such as polycystic ovary syndrome hyperprolactinemia hyperandrogenism thyroid dysfunction functional hypothalamic amenorrhea ovarian resistance syndrome etc; (3) Early onset ovarian dysfunction caused by chromosomal abnormalities or gene mutations iatrogenic factors (radiotherapy chemotherapy); (4) Have received relevant hormone or traditional Chinese medicine treatment non hormone drugs and non drug treatment (such as acupuncture and moxibustion external application enema etc.) that have therapeutic effects on the disease in the last month; (5) Pregnant and lactating women or those with fertility plans within six months; (6) ALT or AST = 1.5 times the upper limit of normal reference value or Scr>the upper limit of normal reference value; (7) Having intellectual disabilities or mental illnesses or neurosis; (8) Merge severe primary diseases such as heart brain lung liver kidney endocrine nervous system and hematopoietic system; (9) Merge known breast ultrasound BI-RADS ratings = 3 and uterine fibroids>4 cm; (10) Combination of estrogen dependent tumors (such as breast cancer endometrial cancer etc.); (11) There are contraindications for the use of estrogen and progesterone; (12) Known or suspected risk of arterial thrombosis; (13) Suspect or have a history of alcohol or drug abuse; (14) Known or suspected history of allergies to the components of the investigational drug; (15) Participated in other clinical trials in the past 3 months; (16) The researchers believe that it is not suitable to participate in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| follicle stimulating hormone; | — |
Secondary
| Measure | Time frame |
|---|---|
| Interleukin-1ß;Tongue image;anti-Müllerian hormone;tumor necrosis factor;Improved Kuperman rating;Traditional Chinese Medicine Syndrome Score;Ovulation rate;estradiol;Serum omics testing: genomics and metabolomics testing;luteinizing hormone;Number of antral follicles;Ovarian arterial/venous blood flow; | — |
Countries
China
Contacts
Public ContactLianwei Xu
Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Outcome results
None listed