Polycystic Ovary Syndrome
Conditions
Interventions
Placebo group:Mulberry total alkaloid tablet placebo treatment for 24 weeks: 1 tablet, starting from three times a day, increasing to 2 tablets three times a week, taking it with the first bite of foo
Mulberry total alkaloid tablet group:Mulberry total alkaloid tablet treatment for 24 weeks: Mulberry total alkaloid tablet 50mg, starting from three times a day, increased to 100mg after a week, three
Metformin + placebo group:Metformin plus placebo treatment for 24 weeks:
Metformin: take 500mg orally after meals, starting from twice a day, and increasing to 500mg three times a week later. If the s
Mulberry total alkaloid tablet placebo: 1 tablet, starting from three times a day, increasing to 2 tablets after a week, three times a day, chewed and taken with the first bite of food.
Mulberry total alkaloid tablet + Metformin group:Mulberry total alkaloid tablet plus Metformin treatment for 24 weeks:
Mulberry total alkaloid tablet: Mulberry total alkaloid tablet 50mg, starting fro
Metformin: take 500mg orally after meals, starting from twice a day, and increasing to 500mg three times a week later. If the subject has intolerable gastrointestinal reactions such as abdominal diste
Follow up study group of Mulberry total alkaloid ta
Sponsors
Wuxi People's Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Women of childbearing age aged 18-45 years; 2. Diagnosed with PCOS according to the diagnostic criteria of the 2018 edition of "Chinese Guidelines for Diagnosis and Treatment of Polycystic Ovary Syndrome"; 3. Have no birth plan within one year and be able to strictly implement contraceptive measures as required; 4. The subjects agreed to participate in the clinical trial and signed the informed consent form voluntarily.
Exclusion criteria
Exclusion criteria: 1. Received a-glucosidase inhibitor, metformin (limited to study 2) or other estrogen and progesterone, lipid-lowering, and hypoglycemic drugs within 12 weeks before the first screening assessment; 2. Those who used glucocorticoids, flora regulators and spironolactone within 12 weeks before the first screening assessment; 3. Suffering from congenital adrenal hyperplasia/hypercortisolism/androgen-secreting tumor/Cushing's syndrome/thyroid dysfunction/hypogonadotropin/hyperprolactinemia disease/premature ovarian insufficiency/function Sexual hypothalamic-pituitary amenorrhea; 4. Liver function ALT and AST > 2 times the upper limit of laboratory normal value; 5. Those who are known to be allergic or intolerant to metformin (limited to study 2), mulberry total alkaloid tablets or any of its components; 6. Women who are pregnant, breastfeeding, or unable to take effective contraceptive measures; 7. According to the medical history, physical examination and routine laboratory examination, the subject has unstable medical conditions, or the investigator considers unstable for other reasons; 8. History of malignant tumor; 9. Those who are deemed unsuitable to participate in clinical trials by the investigator for other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Testosterone;Sex hormone binding globulin; | — |
Secondary
| Measure | Time frame |
|---|---|
| Body Mass Index;Blood lipids;Glycated hemoglobin;Luteinizing Hormone/Follicular Stimulating Hormone;Anti-mullerian hormone;Psychological scale;Menstrual cycle; | — |
Countries
China
Contacts
Public ContactXu Lan
Wuxi People's Hospital
Outcome results
None listed