Polycystic Ovary Syndrome
Conditions
Interventions
Combined Chinese and Western medicine treatment group:OCs containing EE 20 µg+Drospirenone 3 mg and Gui Zhu Yi Kun Fang
Western medicine treatment group:OCs containing EE 20 µg+Drospirenone 3 mg and Gui Zhu Yi Kun Fang Placebo
Sponsors
Beijing Hospital of Traditional Chinese Medicine Capital Medical University
Eligibility
Sex/Gender
Female
Age
20 Years to 40 Years
Inclusion criteria
Inclusion criteria: 1. 20 years old = 40 years old; 2. Meet the diagnostic criteria for PCOS; 3. Meet the diagnostic criteria of abnormal total cholesterol and the risk stratification for the development of atherosclerotic cardiovascular disease (ASCVD) is medium-low risk; 4. Chinese medicine diagnosis in accordance with the spleen and kidney deficiency dampness and turbidity agglomeration evidence; 5. Those who voluntarily participate and sign the informed consent and are willing to accept the information collection.
Exclusion criteria
Exclusion criteria: 1. Combination of other endocrine or metabolic-immune system disorders that affect ovulation or influence the evaluation of drug efficacy such as early onset ovarian insufficiency hyperprolactinemia (e.g. pituitary microadenomas) due to non-polycystic ovary syndrome poorly controlled thyroid disease hypothalamic amenorrhea and pelvic tuberculosis; 2. Pregnant or lactating women or history of miscarriage within 3 months; 3. The presence of contraindications to short-acting oral contraceptives; 4. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 1.5 times the upper limit of the normal reference value or blood creatinine (Cr) > upper limit of the normal reference value; 5. Combined cardiovascular cerebrovascular hepatic renal hematologic and other serious primary diseases oncological diseases psychiatric disorders or mental retardation; 6. Those who have been treated with estrogen and progesterone drugs such as Daying 35 and Yosuyo in the last 3 months and those who have been treated with drugs affecting lipid metabolism and traditional Chinese medicine in the last 1 month; 7. Gynecological examination or B-ultrasound or other examinations confirm that there are organic diseases of the reproductive organs such as endometriosis uterine smooth muscle tumors (average diameter of >4cm) and reproductive organs deformities; 8. Known hypersensitivity to the components of the test drug; 9. Other conditions that the investigator considers inappropriate for participation in this clinical trial; 10. Undergoing research in other clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| total cholesterol; | — |
Secondary
| Measure | Time frame |
|---|---|
| low density lipoprotein,triglyceride,high density lipoprotein ;liver ultrasound,Liver elastography;pelvic ultrasound;Pregnancy;Body Mass Index,waist measurement,hip measurement;basal body temperature;Chinese Medicine Symptom Score;sex hormone,fasting blood glucose; | — |
Countries
China
Contacts
Public ContactQing Tong
Beijing Hospital of Traditional Chinese Medicine Capital Medical University
Outcome results
None listed