The eastern and western medicine have different thinking mode under different philosophy. This article discussed on special ethical issues which were encountered in the clinical research of traditional Chinese medicine (TCM) and different from western medicine. The connotation of ethical review should also be adapted to the characteristics of TCM. This paper discussed these problems, and put forward the idea that ethical review system should be built according to TCM characteristics. Standards for TCM ethical review should be established in order to promote the research progress of TCM and maintain the legitimate rights of TCM subjects.

Objective To assess effectiveness of ketogenic diet on improving polycystic ovary syndrome (PCOS) patients accompanying with overweight and obesity. Methods A total of 72 PCOS patients planned to recruit in our study from December 29, 2018 to June 2019 were selected, and were randomly divided into experimental group and control group. The control group was given routine treatment and suggestions of life style, while the experimental group carried out ketogenic diet intervention alone for three months. All patients were followed up every day and rechecked monthly. The safety and effectiveness indexes of the two groups were observed. Results A total of fifty patients had been recruited until March 30, 2019, but one patient was lost in the follow-up. As a result, there were totally twenty-five patients in the experimental group with one patient lost in follow-up. In the remaining twenty-four patients, 75％ of these patients had recovered spontaneous menstruation in good condition. Ten patients who have been intervened over one month accepted the first re-examination. The results showed that the patient's weight, the body fat rate and the level of androgen detected in venous blood were all reduced after ketogenic diet after the intervention (P ＜ 0. 01), which revealed that the effect of ketogenic diet's intervention for PCOS was significant in the short term. Conclusion Ketogenic diet intervene in PCOS effectively restore spontaneous menstruation in patients for one month, the state of hyperandrogenism is significantly improved. Other hormones show improvement trends, but no significant difference compared with baseline. The mid-term and final reports of KIDs-001 are worthy of the wait.

Objective To assess effectiveness of ketogenic diet on improving polycystic ovary syndrome (PCOS) patients accompanying with overweight and obesity. Methods A total of 72 PCOS patients planned to recruit in our study from December 29, 2018 to June 2019 were selected, and were randomly divided into experimental group and control group. The control group was given routine treatment and suggestions of life style, while the experimental group carried out ketogenic diet intervention alone for three months. All patients were followed up every day and rechecked monthly. The safety and effectiveness indexes of the two groups were observed. Results A total of fifty patients had been recruited until March 30, 2019, but one patient was lost in the follow-up. As a result, there were totally twenty-five patients in the experimental group with one patient lost in follow-up. In the remaining twenty-four patients, 75％ of these patients had recovered spontaneous menstruation in good condition. Ten patients who have been intervened over one month accepted the first re-examination. The results showed that the patient's weight, the body fat rate and the level of androgen detected in venous blood were all reduced after ketogenic diet after the intervention (P ＜ 0. 01), which revealed that the effect of ketogenic diet's intervention for PCOS was significant in the short term. Conclusion Ketogenic diet intervene in PCOS effectively restore spontaneous menstruation in patients for one month, the state of hyperandrogenism is significantly improved. Other hormones show improvement trends, but no significant difference compared with baseline. The mid-term and final reports of KIDs-001 are worthy of the wait.