Polycystic ovary syndrome
Conditions
Interventions
Chinese medicine group:Bu-Shen-Hua-Tan+LE
Control group:Bu-Shen-Hua-Tan placebo+LE
Sponsors
First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Eligibility
Sex/Gender
Female
Age
18 Years to 40 Years
Inclusion criteria
Inclusion criteria: 1. Age 18–40 years; 2. Meets the diagnostic criteria for PCOS as outlined in the Recommendations from the 2023 International Evidence-based Guideline for the Assessment and Management of Polycystic Ovary Syndrome; 3. Meets TCM pattern differentiation criteria for spleen-kidney yang deficiency with phlegm-damp obstruction; 4. Has not used contraception and has not conceived for =12 months; 5. Volunteers for participation and agrees to sign an informed consent form.
Exclusion criteria
Exclusion criteria: 1. Individuals with severe concomitant diseases involving vital organs such as the heart, kidneys, or liver, as well as those with cognitive impairment or psychiatric disorders; 2. Individuals with concomitant endocrine disorders other than PCOS (e.g., thyroid disease, hyperprolactinemia, adrenal tumors) or organic lesions of the reproductive organs; 3. Individuals who have used hormonal medications or drugs affecting reproductive endocrine function and metabolism within the past 12 weeks; 4. Individuals who have undergone PCOS-related drug or supplement therapy (including acupuncture, traditional Chinese medicine, Chinese patent medicines, and other complementary and alternative therapies) within the past 8 weeks; 5. Individuals experiencing infertility due to other causes such as tubal factors or male-related factors.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Live birth rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical pregnancy rate;Biochemical pregnancy rate;Ongoing pregnancy rate;Abortion rate;Fasting plasma glucose;Fasting insulin;Homeostasis model assessment of insulin resistance;2 - hour postprandial blood glucose;2 - hour postprandial Insulin;Cholesterol total;Triglyceride;Low-density lipoprotein cholesterol;High-density lipoprotein cholesterol;Follicle stimulating hormone;Luteinizing hormone;Estradial;Progesterone Prog;Prolactin;Testosterone;Androstenedione;Sex hormone-binding globulin;Dehydroepiandrosterone;Fatty acid metabolism levels;Peripheral blood DNA methylation levels;Placental DNA methylation levels;DNA Methylation Levels in Umbilical Cord Blood from Newborns;TETs;DNMTs;5mc;5hmc; | — |
Countries
China
Contacts
Public ContactWu Linling
First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Outcome results
None listed