Study on urinary metabolomics of premenstrual dysphoric disorder patients with liver-qi depression syndrome treated with Xiaoyaosan: Study Protocol Clinical Trial (SPIRIT Compliant)

INTRODUCTION: Premenstrual dysphoric disorder (PMDD) is a serious form of premenstrual syndrome with mental symptoms as its main manifestation, which seriously affects women's health and daily life. Some basic research and clinical studies have shown that the Chinese herbal medicine of Xiaoyaosan can relieve the symptoms of mental disorders with few side effects. The aim of this study is to evaluate the clinical efficacy of Xiaoyaosan for treating PMDD with liver-qi depression syndrome. In addition, metabonomics and small molecular marker compounds closely related to the pathogenesis of PMDD are expected to be found, and mechanism of Xiaoyaosan is further explored from the metabolic level. METHODS AND ANALYSIS: This study is a clinical pilot trial. Thirty PMDD patients with liver-qi depression syndrome and thirty healthy participants will be recruited. Study participants will be assigned in a 1:1 ratio to 2 groups: a normal control group and Xiaoyaosan treatment group. The treatment group will receive the Chinese patent medicine of Xiaoyaosan for 3 menstrual cycles. The primary outcome is the syndrome change in the Daily Record of Severity of Problems (DRSP). The secondary outcome is improvement in TCM syndrome, which will be measured with TCM symptom score scale. Urine metabolism profiles of participants by liquid chromatograph-mass spectrometer (LC-MS) method will be measured to explore the mechanism of PMDD pathogenesis and action of Xiaoyaosan on PMDD. DISCUSSION: This trial will evaluate the effectiveness and the therapeutic mechanism from the metabolomics level of Xiaoyaosan in individuals with PMDD. If successful, the outcome of this trial will provide a viable treatment option for PMDD patients and objective evidence on the efficacy of Xiaoyaosan for PMDD. ETHICS AND DISSEMINATION: The trial has been approved by the Institutional Ethics Committee of Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine (file number: DZMEC-KY-2019-73). Written informed consent will be obtained from all participants. The results of the study will be published in peer-reviewed journals or communicated via yearly reports to funding bodies. TRIAL REGISTRATION: Chinese Clinical Trial Registry, ChiCTR1900026296.