New insomnia clinical trial underway at NICM Health Research Institute
A herbal remedy may offer relief to the millions of modern-day Australians who are not getting the sleep they need.
During Sleep Awareness Week (5-11 August), researchers from NICM Health Research Institute, Western Sydney University are inviting volunteers to participate in a new clinical trial examining the effectiveness of a herbal formula to treat chronic insomnia. Participants in the study, must be over 18 and have experienced difficulty sleeping at least three times a week and for at least three months.
Insomnia is defined as difficulty falling asleep or staying asleep. It affects one-third of Australians and can have severe consequences on physical health, mental health and daily performance. Causes include stress, anxiety and depression, and some medications. Digital gadgets and long working hours have also been blamed.
A recent inquiry into sleep awareness in Australia has called for the issue to be made a national priority, and for sleep to be recognised as the “third pillar” of a healthy lifestyle alongside diet and exercise. It estimated the financial cost of poor sleep at $26.2 billion a year.
Lead researcher, Yoann Birling from NICM Health Research Institute says he hoped the trial would offer a safe, effective alternative to patients who did not experience relief using current treatments.
“Chronic insomnia – which occurs when a person experiences disrupted sleep at least three nights per week and lasts at least three months - is a multi-dimensional condition with long-term impacts including cardiovascular problems, depression and anxiety,” Mr Birling said.
“Current treatments include hypnotic drugs, which can have side effects and lead to possible dependency, or psychotherapy, which can be difficult to access and demands a long-term commitment including behaviour change.”
“In addition, previous studies suggest people are looking for a non pharmacological treatments for insomnia, which our study will also explore through qualitative methods.”
The double-blind, randomised-controlled trial will assess 90 study participants - ingesting either the herbal capsule or a placebo - in key areas including: insomnia severity, sleep parameters, fatigue levels, psychological status, quality of life, and adverse events before treatment, mid-treatment, post-treatment, and at a one-month follow up.
The traditional Chinese herbal formula includes Spine Date Seed, Danshen Root and Chinese Magnoliavine Fruit, and has been widely use in hospitals in China for over 30 years.
Mr Birling says some early clinical trials in China have so far delivered promising results, however more research is needed to obtain conclusive results.
“Our study will look for evidence of the safety and effectiveness of this formula and determine whether its benefit continues after an initial five-week treatment regime.”
If you have experienced trouble sleeping you may be eligible to join the study, for more information visit www.nicm.edu.au/insomniastudy
This study has been approved by the Western Sydney University Human Research Ethics Committee, approval number H12990.This research is funded by Western Sydney University. ZRAS capsules and placebos were provided by Global Therapeutics Pty Ltd. The lead investigator, Yoann Birling is a recipient of a NICMHRI-Blackmores Institute Scholarship.