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.

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  • Additional Information
    • Source:
      Publisher: BioMed Central Country of Publication: England NLM ID: 101263253 Publication Model: Electronic Cited Medium: Internet ISSN: 1745-6215 (Electronic) Linking ISSN: 17456215 NLM ISO Abbreviation: Trials Subsets: MEDLINE
    • Publication Information:
      Original Publication: [London] : BioMed Central, 2006-
    • Subject Terms:
      Drugs, Chinese Herbal/*adverse effects ; Heart Diseases/*complications ; Kidney Diseases/*complications ; Phytotherapy/*methods ; Sleep Initiation and Maintenance Disorders/*etiology ; Sleep Initiation and Maintenance Disorders/*therapy; Adolescent ; Adult ; Double-Blind Method ; Female ; Humans ; Male ; Middle Aged ; Polysomnography ; Randomized Controlled Trials as Topic ; Sleep/drug effects ; Treatment Outcome ; Young Adult
    • Abstract:
      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, 1 H-magnetic resonance spectroscopy ( 1 H-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.
      Trial Registration: Chinese Clinical Trial Registry, ChiCTR1800019239. Registered on 1st November 2018.
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    • Grant Information:
      81673733 National Natural Science Foundation of China
    • Contributed Indexing:
      Keywords: Insomnia; Jiao-tai-wan; Pattern identification; Randomized controlled trial; Study protocol; Traditional herbal medicine
    • Accession Number:
      0 (Drugs, Chinese Herbal)
      0 (jiao tai wan)
    • Publication Date:
      Date Created: 20200517 Date Completed: 20210125 Latest Revision: 20210125
    • Publication Date:
      20231215
    • Accession Number:
      PMC7227231
    • Accession Number:
      10.1186/s13063-020-04299-x
    • Accession Number:
      32414414