Impact of Zao Ren An Shen (ZRAS) capsule on chronic insomnia patients' insomnia severity: A randomized-controlled trial
  • Description

    This study is a randomized-controlled-trial that aims to assess the efficacy and safety of Zao Ren An Shen (ZRAS) capsule, a Chinese herbal medicine product, for chronic insomnia. After a 1-week placebo run-in, the participants will be randomized to either the experimental group or the placebo group and asked to take three capsule of either ZRAS or placebo every day before bedtime for four weeks. The outcomes will be assessed continuously with a sleep diary and actigraphy, and at baseline, mid-treatement (week 2), post-treatment and follow-up (week 8) with questionnnaires about insomnia severity, fatigue severity, psychological status, and quality of life. The hypothesis is that ZRAS is efficient and safe for chronic insomnia. The dataset relates to the clinical trial ACTRN12619000140156 Investigation of the efficacy and safety of Zao Ren An Shen (ZRAS) capsule for chronic insomnia. This data cannot be shared publicly due to ethics approval conditions. To discuss this data, please contact the NICM Health Research Institute nicm@westernsydney.edu.au.


    • - Start
      Data publication title Impact of Zao Ren An Shen (ZRAS) capsule on chronic insomnia patients' insomnia severity: A randomized-controlled trial
    • Description

      This study is a randomized-controlled-trial that aims to assess the efficacy and safety of Zao Ren An Shen (ZRAS) capsule, a Chinese herbal medicine product, for chronic insomnia. After a 1-week placebo run-in, the participants will be randomized to either the experimental group or the placebo group and asked to take three capsule of either ZRAS or placebo every day before bedtime for four weeks. The outcomes will be assessed continuously with a sleep diary and actigraphy, and at baseline, mid-treatement (week 2), post-treatment and follow-up (week 8) with questionnnaires about insomnia severity, fatigue severity, psychological status, and quality of life. The hypothesis is that ZRAS is efficient and safe for chronic insomnia. The dataset relates to the clinical trial ACTRN12619000140156 Investigation of the efficacy and safety of Zao Ren An Shen (ZRAS) capsule for chronic insomnia. This data cannot be shared publicly due to ethics approval conditions. To discuss this data, please contact the NICM Health Research Institute nicm@westernsydney.edu.au.


      • Data type dataset
    • Keywords
      • Chinese medicine
      • ZRAS
      • herbal medicine
      • insomnia
      • sleep
      • clinical trial
      • ACTRN12619000140156
    • Funding source
    • Grant number(s)
      • -
      • FoR codes
      • 420803 - Traditional Chinese medicine and treatments
      • 420399 - Health services and systems not elsewhere classified
      SEO codes
      • 200199 - Clinical health not elsewhere classified
    - Coverage
      Temporal (time) coverage
    • Start date 2019/04/04
    • End date 2021/01/28
      • Time period
       
      Spatial (location,mapping) coverage
    • Locations
      • Australia
    - Data
      Data Locations

      Type Location Notes
      The Data Manager is: Suzannah Bourchier
      Access conditions Restricted
    - Supplements
    - License
      The data will be licensed under
    • Other license
      • Statement of rights in data Copyright Western Sydney University
    - Citation
      Citation Birling, Yoann; Zhu, Xiaoshu; Avard, Nicole; Tannous, Caterina; Fahey, Paul; Sarris, Jerome; Bensoussan, Alan (2025): Impact of Zao Ren An Shen (ZRAS) capsule on chronic insomnia patients' insomnia severity: A randomized-controlled trial. Western Sydney University. https://doi.org/10.26183/jprt-8g55

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