Efficacy and Safety of Dingkundan Combined With Combination Oral Contraceptives in the Treatment of PCOS: an Open-label, Non-randomized Controlled Clinical Study

In this study, the decreased level of serum androgen was used as the main outcome index. It was assumed that PCOS patients treated with Dingkundan combined with compound oral contraceptives for 3 menstrual cycles had decreased serum androgen by 0.53nmol/L. It was assumed that the serum androgen decreased by 0.21nmol/L after 3 menstrual cycles of combined oral contraceptives alone. If α = 0.05, the test degree was 80%, and the dropout rate of 20%, considering that the sample size ratio between the experimental group and control group was 1, the sample size of experimental group and control group were 60 cases each, and 120 cases in total. All the samples were recruited from the Department of Gynecology and Women's Health Care of Guangdong Women and Children's Health Hospital.

This study was approved by the Ethics Committee of the hospital, and all participants are required to sign informed consent.

Before the study, researchers should be trained in a unified and standardized manner, including medication methods, observation indicators, judgment and treatment of adverse reactions/events, and reporting of serious adverse events.

The researcher must adequately and accurately record the research process so that the research data can be verified. These records can be divided into two categories: study documents and raw patient data. Study documents include protocols and amendments, sample informed consent forms, researcher resumes and authorization forms, and other required documents and correspondence. Original documents of patients' include patient inpatient/outpatient records, doctor's and nurse's orders, appointment dates, original laboratory reports, ultrasound, signed informed consent forms, patient screening forms, etc.

During the study period, if the subject withdraws the informed consent, or refuses the further follow-up, or loses follow-up, or dies, the sample will be disqualified.