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

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 [email protected].