Premature Ovarian Insufficiency
Conditions
Interventions
Test group: Zishen Yutai Pills
Placebo group: placebo similar to Zishen Yutai Pills
Sponsors
Shuguang Hospital affiliated to Shanghai University of TCM
Eligibility
Sex/Gender
Female
Age
20 Years to 40 Years
Inclusion criteria
Inclusion criteria: (1) Meeting POI criteria according to Western medical diagnosis;(According to the Evidence-Based Guidelines: Premature Ovarian Insufficiency (2024 Edition) 1) Menstrual abnormalities: Spontaneous amenorrhea or menstrual irregularity lasting =4 months; 2) Biochemical indicators: Serum FSH level >25 IU/L (regardless of specific menstrual cycle timing).) (2) Diagnosed with spleen-kidney deficiency syndrome based on Traditional Chinese Medicine pattern differentiation; (3) Women with a history of sexual activity; (4) Voluntarily participating in this clinical trial, having provided informed consent and signed a written informed consent form.
Exclusion criteria
Exclusion criteria: (1) FSH > 40 IU/L; (2) Concurrent reproductive endocrine or metabolic/immune system disorders affecting ovarian function or drug efficacy assessment, such as poorly controlled thyroid disease or Addison's disease; (3) Menstrual cessation exceeding 6 months; (4) Use of related hormonal medications or traditional Chinese medicine/formulations for POI within the past 3 months; (5) Chromosomal abnormalities or carriers thereof, or congenital reproductive organ developmental anomalies; (6) Participation in other clinical trials within 1 month prior to randomization or ongoing participation in other trials; (7) Concurrent severe cardiovascular, cerebrovascular, hepatic, renal, malignant neoplastic, hematopoietic system, or psychiatric disorders; (8) Suspected or confirmed alcohol or substance abuse; (9) Habitual daily smoking exceeding 10 cigarettes within 3 months prior to randomization; (10) Known allergy to any component of the study drug; (11) Subjects deemed unsuitable for this clinical trial by the investigator; (12) Subjects or their spouses planning pregnancy during the trial period or unwilling to use barrier contraception exclusively (excluding hormonal contraceptives).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Modified Kupperman Score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Traditional Chinese Medicine Syndrome Score;Menstrual Score;Serum hormones:FSH LH FSH/LH E2 AMH.etc.;Ultrasound examination parameters: Number of antral follicles (AFC) in both ovaries, Volume of both ovaries, Ovarian blood flow parameters, Endometrial thickness, etc.;Self-RatingAnxietyScale; | — |
Countries
China
Contacts
Public ContactYuanyuan Wu
Shuguang Hospital affiliated to Shanghai University of TCM
Outcome results
None listed