Premature ovarian insufficiency and diminished ovarian reserve
Conditions
Interventions
High-dose group:Wubie Huaiwei Granules, dissolve in boiling water. Take 2 bags each time, twice a day.
Low-dose group:Wubeihuan gui Granules, dissolve in boiling water. Take 2 sachets (1 sachet of Wubeihuan gui Granules + 1 sachet of placebo (simulator of Wubeihuan gui Granules)) per dose, twice daily.
Placebo group:Placebo (Wubie Huangu Granules simulant), dissolve in boiling water. Take 2 sachets once, 2 times daily.
Sponsors
Guang'anmen Hospital of the Chinese Academy of Traditional Medicine
Eligibility
Sex/Gender
Female
Age
20 Years to 40 Years
Inclusion criteria
Inclusion criteria: (1) Meets the diagnostic criteria for early-onset ovarian insufficiency in Western medicine, with oligomenorrhea (cycle frequency >35 days) for =4 months or amenorrhea for 4-6 months, and serum basal FSH levels between 25 U/L and 40 U/L (two measurements, with an interval >4 weeks); or meets the diagnostic criteria for diminished ovarian reserve in Western medicine; (2) Meets the diagnostic criteria for kidney yin deficiency syndrome in Traditional Chinese Medicine; (3) Age between 20 and 40 years (inclusive); (4) Participants who do not plan to conceive within 1 year after enrollment; fertile female participants must use effective contraceptive measures during the study and for 6 months after the last dose of study medication (e.g., complete abstinence, condom, cervical cap with spermicide, or intrauterine device [IUD]); (5) Provides written informed consent after full understanding of the study.
Exclusion criteria
Exclusion criteria: (1) Congenital abnormalities of reproductive organ development; chromosomal abnormalities; acquired organic lesions or injuries of reproductive organs; other endocrine diseases (such as polycystic ovary syndrome, hyperprolactinemia, hyperandrogenism, thyroid dysfunction, adrenal dysfunction, hypothalamic-pituitary disorders, ovarian resistance syndrome) causing amenorrhea or oligomenorrhea; iatrogenic POI (including chemotherapy, radiotherapy, surgery, excluding POI caused by ovarian stimulation drugs for IVF); ovarian reserve function decline caused by iatrogenic factors such as surgery, radiotherapy, or chemotherapy. (2) Uterine fibroids with the largest single diameter =4 cm; endometrial polyps with the largest single diameter >1.5 cm; adnexal masses with the largest single diameter =4 cm; severe endometriosis (ASRM stage IV). (3) Breast ultrasound BI-RADS rating =4. (4) Severe primary diseases of cardiovascular, hepatic, renal, endocrine, nervous, or hematopoietic systems; patients with malignant tumors; patients with mental illness. (5) BMI =30 kg/m². (6) Allergic constitution (e.g., allergy to two or more drugs or foods) or allergy to components of the investigational drug. (7) Patients with a personal history of liver damage caused by the use of Polygonum multiflorum (He Shou Wu) or its formulated preparations. (8) Suspected or confirmed history of alcohol or substance abuse. (9) Red blood cell count and hemoglobin below the lower limit of normal; reticulocyte count > upper limit of normal (ULN); alanine aminotransferase (ALT) or aspartate aminotransferase (AST), total bilirubin (TBIL) > upper limit of normal (ULN); serum creatinine (Scr) > upper limit of normal (ULN); creatinine clearance rate 1 mg) related to this condition within 4 weeks prior to screening; or received progesterone therapy (equivalent to dydrogesterone >10 mg) related to this condition within 4 weeks prior to screening; or used long-acting gonadotropin-releasing hormone (GnRH) agonists within 3 months prior to screening. (11) Received non-hormonal drugs or non-drug therapies (e.g., acupuncture, topical application, etc.) with therapeutic effects on this condition within 4 weeks prior to enrollment. (12) Participants in other clinical trials within the past 3 months. (13) Other situations deemed unsuitable for participation in this clinical trial by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of patients with normal menstrual.; | — |
Secondary
| Measure | Time frame |
|---|---|
| The proportion of patients with a normal menstrual cycle.;The proportion of patients with a normal menstrual cycle.;The proportion of patients with normal menstrual flow;Evaluate the proportion of patients with spontaneous menstruation in the menopausal subgroup.;the proportion of patients with Follicle Stimulating Hormone (FSH) returning to normal;The proportion of patients whose Anti-Müllerian Hormone (AMH) has returned to normal;Recurrence rate of oligomenorrhea or amenorrhea (evaluated based on cases where menstrual cycles returned to normal after 24 weeks of medication).;Follicle Stimulating Hormone(FSH) Abnormality Recurrence Rate (evaluated in cases where FSH returned to normal after 24 weeks of treatment);Anti-Müllerian Hormone(AMH) Abnormality Recurrence Rate (Assessed in cases where AMH returned to normal after 24 weeks of treatment);Changes in sex hormone indicators (Follicle Stimulating Hormone, Luteinizing hormone,, Estradiol, Proglsterone) from baseline values.;Anti-Müllerian Hormone change from baseline;Gynecological B-mode ultrasound (endometrial thickness, antral follicle count, uterine volume, ovarian volume) improvement compared to baseline.;TCM symptom score improvement rate compared to baseline; | — |
Countries
China
Contacts
Public ContactZhao Ruihua
Guang'anmen Hospital of the Chinese Academy of Traditional Medicine
Outcome results
None listed