None listed
Conditions
Brief summary
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.
Interventions
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 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.
Sponsors
Western Sydney University, NICM Health Research Institute
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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.
Exclusion criteria
1. Imminent need of psychiatric (e.g., suicide risk) or medical care (e.g., stroke). 2. Abnormal blood tests, including Full Blood Count (FBC), Liver Function Test (LFT), and Electrolytes-Urea-Creatinine (EUC), within the last six months, if not approved by a general practitioner. 3. No evidence that substance use (e.g., caffeine or a medication), coexisting medical conditions or mental disorders, including sleep-wake disorder, do not adequately explain the predominant complaint of insomnia. 4. Use of any treatment for insomnia less than 14 days prior to randomization. 5. Any psychotic disorder or bipolar disorder if not appropriately treated or stable for less than two years. 6. Alcohol or drug addiction. 7. Other mental disorders such as major depressive disorder or generalized anxiety disorder, if the disorder is untreated or treated for less than one month. 8. Cognitive impairment preventing the participant to understand the trial instructions, complete questionnaires or provide informed consent. 9. Allergy history to any of the ingredient of the ZRAS capsule or the placebo. 10. Taking a Warfarin-type anticoagulant, quetiapine, clozapine, or olanzapine . 11. Women being pregnant or breast-feeding. 12. Considered not suitable for the trial by the investigator.
Outcome results
None listed