Jiao-tai-wan for insomnia symptoms caused by the disharmony of the heart and kidney: a study protocol for a randomized, double-blind, placebo-controlled trial

doi:10.1186/s13063-020-04299-x

科研成果详情

题名	Jiao-tai-wan for insomnia symptoms caused by the disharmony of the heart and kidney: a study protocol for a randomized, double-blind, placebo-controlled trial
作者	Zeng, Congcong 1; Liu, Xi 2; Hu, Lufeng3; Feng, Yuan 4; Xia, Nengzhi5; Zeng, Haihuan 6; Luo, Lin 7; Ye, Ren1; Yuan, Zhengzhong1
发表日期	2020-05-15
发表期刊	TRIALS 影响因子和分区
语种	英语
原始文献类型	Article
关键词	Jiao-tai-wan Insomnia Traditional herbal medicine Randomized controlled trial Study protocol Pattern identification
其他关键词	MAGNETIC-RESONANCE SPECTROSCOPY ; PRACTICE PARAMETERS ; SLEEP ; ADENOSINE ; MEDICINE ; UPDATE ; BRAIN ; CARE ; GABA
摘要	Background Insomnia seriously affects people's normal lives and work. However, effective treatment strategies are scarce. The purpose of this study is to explore the efficacy and safety of Jiao-tai-wan (JTW) for ameliorating insomnia symptoms caused by disharmony of the heart and kidney. Design This is a randomized, double-blind, placebo-controlled pilot clinical trial. A total of 124 participants suffering from insomnia symptoms will be randomly assigned to the JTW or placebo group in an equal ratio. The participants will be asked to take JTW or placebo granules twice a day for 1 week. All data will be gathered at baseline and at the end of the drug intervention. The primary outcome measures will be the mean change in the Pittsburgh Sleep Quality Index (PSQI) from baseline to the end of the drug intervention. Secondary outcome measures will include the altered sleep parameters in polysomnography, H-1-magnetic resonance spectroscopy (H-1-MRS) evaluation, the Disharmony of Heart and Kidney Scoring System score, and blood tests, including the levels of serum adenosine and melatonin. A laboratory test will be taken before and after treatment to assess the safety of JTW. Discussion The outcomes of this study will confirm the efficacy of JTW for the treatment of insomnia symptoms and will also be used to monitor the safety of JTW.
资助项目	National Natural Science Foundation of ChinaNational Natural Science Foundation of China (NSFC) [81673733]
出版者	BMC
出版地	LONDON
ISSN	1745-6215
EISSN	1745-6215
卷号	21 期号:1 页码:408
DOI	10.1186/s13063-020-04299-x
页数	9
WOS类目	Medicine, Research & Experimental
WOS研究方向	Research & Experimental Medicine
WOS记录号	WOS:000536190400001
收录类别	SCIE ; PUBMED ; SCOPUS
URL	查看原文
PubMed ID	32414414
PMC记录号	PMC7227231
SCOPUSEID	2-s2.0-85084787812
通讯作者地址	[Ye, Ren;Yuan, Zhengzhong]Wenzhou Med Univ, Dept Tradit Chinese Med, Affiliated Hosp 1, Wenzhou 325035, Zhejiang, Peoples R China.
Scopus学科分类	Medicine (miscellaneous);Pharmacology (medical)
引用统计	被引频次：4[WOS] [WOS记录] [WOS相关记录]
文献类型	期刊论文
条目标识符	https://kms.wmu.edu.cn/handle/3ETUA0LF/7183
专题	附属第一医院_中医科第二临床医学院、附属第二医院、育英儿童医院附属第一医院_药学部药学部
通讯作者	Ye, Ren; Yuan, Zhengzhong
作者单位	1.Wenzhou Med Univ, Dept Tradit Chinese Med, Affiliated Hosp 1, Wenzhou 325035, Zhejiang, Peoples R China; 2.Zhejiang Chinese Med Univ, Binwen Rd, Hangzhou 310053, Zhejiang, Peoples R China; 3.Wenzhou Med Univ, Dept Pharm, Affiliated Hosp 1, Wenzhou 325035, Zhejiang, Peoples R China; 4.Wenzhou Med Univ, 2nd Clin Coll, Chashan Higher Educ Pk, Wenzhou 325035, Zhejiang, Peoples R China; 5.Wenzhou Med Univ, Xray Dept, Affiliated Hosp 1, Wenzhou 325035, Zhejiang, Peoples R China; 6.Wenzhou Med Univ, Sleep Monitoring Ctr, Affiliated Hosp 1, Wenzhou 325035, Zhejiang, Peoples R China; 7.China Acad Chinese Med Sci, Res Inst, 16 Nanxiao St, Beijing 100700, Peoples R China
第一作者单位	附属第一医院; 中医科
通讯作者单位	附属第一医院; 中医科
第一作者的第一单位	附属第一医院
推荐引用方式 GB/T 7714	Zeng, Congcong,Liu, Xi,Hu, Lufeng,et al. Jiao-tai-wan for insomnia symptoms caused by the disharmony of the heart and kidney: a study protocol for a randomized, double-blind, placebo-controlled trial[J]. TRIALS,2020,21(1):408.
APA	Zeng, Congcong., Liu, Xi., Hu, Lufeng., Feng, Yuan., Xia, Nengzhi., ... & Yuan, Zhengzhong. (2020). Jiao-tai-wan for insomnia symptoms caused by the disharmony of the heart and kidney: a study protocol for a randomized, double-blind, placebo-controlled trial. TRIALS, 21(1), 408.
MLA	Zeng, Congcong,et al."Jiao-tai-wan for insomnia symptoms caused by the disharmony of the heart and kidney: a study protocol for a randomized, double-blind, placebo-controlled trial".TRIALS 21.1(2020):408.