Polycystic Ovary Syndrome
Conditions
Interventions
Treatment group (Kidney-yang deficiency and phlegm obstruction type):Shenluo Tiaojing pills 12 g/dose, twice daily, taken with warm water at half an hour after meal for 6 months in total
Control group (Kidney-yang deficiency and phlegm obstruction type):Drospirenone and ethinylestradioltablets, from the fifth day of menstruation, one tablet at the same time every day for 21 consecutiv
Treatment group (Kidney-yin deficiency and phlegm-stasis type):Shenluo Yunchun pills 15 g/dose, twice daily, taken with warm water at half an hour after meal for 6 months in total
Control group (Kidney-yin deficiency and phlegm-stasis type):Metformin hydrochloride tablets, taken orally with meals starting from the first day of menstruation, 500mg/dose, three times a day, for 6
Sponsors
Shanghai Taikuntang Hospital of TCM
Eligibility
Sex/Gender
Female
Age
16 Years to 40 Years
Inclusion criteria
Inclusion criteria: 1) Patients aged 16~40 (included); 2) Those conforming to PCOS diagnostic criteria, with duration of disease =6 months 3) Those with PCOS of kidney-yang deficiency and phlegm obstruction type or kidney-yin deficiency and phlegm-stasis type in TCM syndrome differentiation; 4) Those who have not received medication or those who have taken medication but stopped it for more than 3 months; 5) Those who have ability to cooperate in observing efficacy and adverse events, as well as recording in the subject diary; 6) Those who voluntarily participate in this clinical study and sign relevant informed consent forms.
Exclusion criteria
Exclusion criteria: 1) Patients with diseases similar to PCOS in clinical and/or endocrine signs caused by other reasons, such as small follicle syndrome, organic lesions of reproductive organs, Cushing's syndrome, hyperhtelosis, adrenal cortical hyperplasia, 21 hydroxylase deficiency, ovarian or adrenal tumors, hyperprolactinemia, thyroid dysfunction, primary diabetes and other metabolic disorders; 2) Those complicated with serious primary diseases such as cardiovascular disease, liver disease, kidney disease and disease of the hematopoietic system, and those diagnosed with diabetes and requiring medication, and those with malignant tumors; 3) Those with intellectual disability or mental illness; 4) Those with suspected or confirmed history of smoking or alcohol or drug abuse; 5) Women who are pregnancy test positive, pregnant or lactating; 6) Those with allergic constitution, allergic to known drugs in this prescription, or having potential discomfort reactions; 7) Those with incomplete data or indeterminate efficacy, which may affect efficacy or safety evaluation; 8) Those who have participated in other clinical trials within 3 months before screening; 9) Those with contraindications to estrogen use that other investigators consider it unsuitable to participate in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Basal Body Temperature;Ultrasound follicle monitoring; | — |
Secondary
| Measure | Time frame |
|---|---|
| BMI;WHR;Acne score;Melanosis (pseudoacanthosis nigricans) score;Determination of sexual hormone levels;OGTT;Insulin release test;Blood lipid; | — |
Countries
China
Contacts
Public ContactLei Zhou
Shanghai Taikuntang Hospital of TCM
Outcome results
None listed