Therapy of replenishing Yin and regulating Yang for manic episode in bipolar disorder:study protocol for a prospective,double-blind,randomized controlled trial

作     者：YANG Yang YUAN Haining JIA Hongxiao NING Yanzhe WANG Di ZHANG Lei YAN Kaijuan GUO Yumeng WANG Fei SUN Weishuang CHEN Pei YANG Yang;YUAN Haining;JIA Hongxiao;NING Yanzhe;WANG Di;ZHANG Lei;YAN Kaijuan;GUO Yumeng;WANG Fei;SUN Weishuang;CHEN Pei

作者机构：Beijing Key Laboratory of Mental DisordersNational Clinical Research Center for Mental Disorders and National Center for Mental DisordersDepartment of integrated traditional Chinese and Western medicineBeijing Anding HospitalCapital Medical UniversityBeijingChina Advanced Innovation Center for Human Brain ProtectionCapital Medical UniversityBeijing 100088China Beijing Key Laboratory of Mental DisordersNational Clinical Research Center for Mental Disorders and National Center for Mental DisordersBeijing Anding HospitalCapital Medical UniversityBeijing 100088China Advanced Innovation Center for Human Brain ProtectionCapital Medical UniversityBeijing 100069China 

出 版 物：《Journal of Traditional Chinese Medicine》 (中医杂志（英文版）)

年 卷 期：2023年第43卷第3期

页      面：594-601页

核心收录：

学科分类：1007[医学-药学(可授医学、理学学位)] 1006[医学-中西医结合] 1005[医学-中医学] 1002[医学-临床医学] 100602[医学-中西医结合临床] 10[医学] 

基　　金：Supported by Beijing Municipal Administration of Hospitals Incubating Program(No.PZ2021031),which plays no role in the design of the study collection,analysis,and interpretation of data,and in writing the manuscript 

主　　题：bipolar disorder replenishing Yin and regulating Yang gastrointestinal microbiome inflammation clinical protocol 

摘      要：Bipolar disorder(BD) is a chronic and recurrent disorder characterized by biphasic mood episodes of mania or hypomania and *** affects more than 1% of the global population and is a leading cause of disability in young *** available treatments for BD are still fairly limited in terms of efficacy,with high rates of non-adherence,non-response,and undesirable side *** Chinese medicine(TCM) has a long history and rich experience in stabilizing mania and improving quality of *** at rebalancing Yin and Yang in BD,therapy of replenishing Yin and regulating Yang(RYRY therapy) has been in clinical use for years in *** present prospective,double-blind,randomized controlled trial is designed to investigate the efficacy and safety of RYRY therapy for bipolar mania and its possible mechanism from the point of regulating gut microbiota and anti-inflammation.A total of 60 eligible participants will be recruited from Beijing Anding *** will be randomized to either the study group or the control group in a ratio of 1∶*** allocated to the study group will receive RYRY granule,while placebo granule will be applied in the control *** in both groups will be prescribed conventional therapy for manic episode in *** scheduled visits will be conducted over 4 *** measurements include Young Mania Rating Scale,TCM Symptom Pattern Rating Scale,Treatment Emergent Symptom Scale,levels of C-reactive protein,interleukin-6 and tumor necrosis factor-α and the gut microbial community profile of stool *** outcomes and adverse events will also be *** this study,we set a number of scientific and objective assessments to evaluate the efficacy of RYRY therapy and study into its possible mechanism,hopefully offering clinicians an alternative approach to BD.