Safety and efficacy of Jiaotai Wan in patients with depression: study protocol for a randomised controlled trial

Background: Depression is a common affective disorder characterised by marked and lasting melancholia, with corresponding thought and behaviour changes. Due to an accelerated pace of life and increased work pressure, the incidence of depression has risen sharply, causing great harm to family and social life. Jiaotai Wan (JTW) is a Chinese herbal formula that is commonly prescribed for depression and insomnia in clinical treatment, and animal experimental research shows that it exhibits antidepressant effects. However, there are no standard clinical trials to confirm its efficacy in treating depression and insomnia. Therefore, this study aims to assess the efficacy and safety of JTW in the treatment of depression. Methods: This study is designed as a randomised, multicentre clinical trial with parallel groups. A total of 40 patients with depression will be recruited and randomly allocated to either the treatment or the control group (in a 1:1 ratio). The patients will receive JTW plus fluoxetine or fluoxetine alone once a day for eight weeks. The primary outcome is the Hamilton Depression Rating Scale score for patients in the treatment group compared with that in the control group. The secondary outcomes include Traditional Chinese medicine syndrome integral scale scores, Wisconsin Card Sorting Test, blood metabonomics, urine metabonomics, brain structure and function on functional magnetic resonance imaging. Discussion: This randomised clinical trial was designed as a standardised method to assess the efficacy and safety of JTW in the treatment of depression and provide evidence for the clinical application of JTW. Trial registration: Chinese Clinical Trial Registry,ChiCTR-IOR-17010748.Registered on 28 Feb 2017.