Investigation of the efficacy and safety of Zao Ren An Shen (ZRAS) capsule for chronic insomnia

INTERVENTION: The investigational product is Zao Ren An Shen (ZRAS) capsule, a Chinese herbal medicine manufactured product. This product is listed in the ARTG under "Zaoren Anshen" with the approval number 301484. In this trial, ZRAS capsule will be provided by a PhD student trained in Chinese medicine to the participant individually in a face‐to‐face fashion at the trial site. The participant will be asked to take orally 3 capsules (2.28g) of ZRAS capsule once daily one hour before bedtime, for 4 weeks. At the end of the intervention, the participants will be asked to return the drug bottles in order to assess adherence to treatment. CONDITION: Alternative and Complementary Medicine ‐ Herbal remedies chronic insomnia; ; chronic insomnia Mental Health ‐ Other mental health disorders PRIMARY OUTCOME: Insomnia severity assessed with the Insomina Severity Scale[Post‐treatment (week 4)] SECONDARY OUTCOME: adverse events will be assessed with interviews and recorded in an Adverse Event Forms designed for this study. INCLUSION CRITERIA: 1. 18 years old or older. 2. Complaint of difficulty initiating or maintaining sleep occurring at least three times per week for at least three months despite adequate opportunity to sleep, and resulting in distress or impaired daytime functioning. 3. ISI score greater than or equal to 10. 4. Willing to abstain from any other treatment for insomnia, including pharmaceutical treatment, CAM, and psychotherapy, during the baseline and intervention periods. 5. Willing to use birth control methods and to not donate sperm during the baseline and intervention periods, or sterile. 6. Ability to understand and speak English. ; Adverse events recorded during previous clinical trials are fatigue, stomach discomfort, diarrhoea, acid reflux, and lips numbness.[mid‐treatment (week 2), post‐treatment (week 4) and follow‐up (week 8)] Depression, anxiety and stress levels measured with the Depression, Anxiety and Stress Scale (DASS)[mid‐treatment (week 2), post‐treatment (week 4) and follow‐up (week 8)] fatigue severity measured with the Fatigue Severity Scale (FSS)[mid‐treatment (week 2), post‐treatment (week 4) and follow‐up (week 8)] Insomnia severity assessed with the Insomnia Severity Scale[mid‐treatment (week 2) and follow‐up (week 8)] Number of awakenings measured with actigraphy[mid‐treatment (week 1, week 2, week 3), post‐treatment (week 4) and follow‐up (week 7)] Number of awakenings measured with the sleep diary[mid‐treatment (week 1, week 2, week 3), post‐treatment (week 4) and follow‐up (week 7)] Quality of life measured with the Assessment of Quality of Life (AQoL)[mid‐treatment (week 2), post‐treatment (week 4) and follow‐up (week 8)] Sleep efficency measured with the sleep diary[mid‐treatment (week 1, week 2, week 3), post‐treatment (week 4) and follow‐up (week 7)] Sleep efficiency measured with actigraphy[mid‐treatment (week 1, week 2, week 3), post‐treatment (week 4) and follow‐up (week 7)] Sleep onset latency measured with actigraphy[mid‐treatment (week 1, week 2, week 3), post‐treatment (week 4) and follow‐up (week 7)] Sleep onset latency measured with the sleep diary[mid‐treatment (week 1, week 2, week 3), post‐treatment (week 4) and follow‐up (week 7)] Total sleep time measured with actigraphy[mid‐treatment (week 1, week 2, week 3), post‐treatment (week 4) and follow‐up (week 7)] Total sleep time measured with the sleep diary[mid‐treatment (week 1, week 2, week 3), post‐treatment (week 4) and follow‐up (week 7)] Wake after sleep onset measured with actigraphy[mid‐treatment (week 1, week 2, week 3), post‐treatment (week 4) and follow‐up (week 7)] Wake after sleep onset measured with the sleep diary[mid‐treatment (week 1, week 2, week 3), post‐treatment (week 4) and follow‐up (week 7)]