POI
Conditions
Interventions
Sponsors
Beijing Obstetrics and Gynecology Hospital, Capital Medical University
Eligibility
Sex/Gender
Female
Age
20 Years to 40 Years
Inclusion criteria
Inclusion criteria: 84/5000 (1) Meet the diagnostic criteria of early onset ovarian insufficiency in Western medicine; (2) Meet the TCM syndrome differentiation standards of deficiency of qi and blood and deficiency of liver and kidney; (3)20 = age < 40; (4) The patient shall give informed consent and sign the informed consent.
Exclusion criteria
Exclusion criteria: (1) Patients with primary POI (no spontaneous menstruation in the past) and iatrogenic POI were clearly diagnosed; Patients with ovarian resistance syndrome, abnormal reproductive tract development, polycystic ovary syndrome, hyperprolactinemia, ovarian endometriosis, central nervous system tumors, functional hypothalamic amenorrhea, thyroid dysfunction, adrenal cortex dysfunction and other related symptoms; (2) women who are pregnant or breastfeeding or have a history of abortion in the last 1 month; (3) patients with serious primary diseases of heart, brain, liver, kidney, hematopoietic and immune systems, blood-borne infectious diseases and mental disorders; (4) Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) were more than 2 times of the upper limit of normal value, and serum creatinine (Cr) was more than the upper limit of normal value; (5) Those who had received hormone supplement therapy (HRT) and/or had taken Traditional Chinese medicines such as supplementing qi and blood, regulating liver and kidney in 1 month before enrollment, and the efficacy of drugs was difficult to judge; (6) with mental disorders, including anxiety disorder (HAMA=14 points), depression (HAMD=17 points), etc.; (7) allergic to the drug ingredients in the known experimental drug; (8) Participate in other clinical studies within 1 month prior to screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| FSH; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disappearance rate of single symptom;AMH;HAMD;TCM syndrome is efficient;AFC;HAMA;Sex hormone change value;Modified Kupperman score; | — |
Countries
china
Contacts
Public Contactruanxiangyan
Outcome results
None listed