Effects of a saffron extract (affron) on adults experiencing mild-to-moderate stress and burnout: a randomised, double-blind, placebo-controlled study

Clinical Research Australia0 个研究点目标入组 80 人开始时间: 2022年4月4日最近更新: 2023年2月20日

试验速览

暂无简介。

•1)Healthy adults (male and female) 18 to 65 years
•2)Engaged in paid work for at least 30 hours a week
•3)Currently experiencing high stress (as determined by a Perceived Stress Scale score of 14 or more)
•4)Currently experiencing low energy/ fatigue as determined by a rating of 5 or more on an 11-point numeric rating scale (0 = no fatigue; 5 = moderately fatigued; to 10 = extremely fatigued)
•5)Non-smoker
•6)BMI between 18 and 30 kg/m2
•7)No plan to commence new treatments over the study period
•8)Understand, willing and able to comply with all study procedures
•9)Willing to provide a personally signed and dated informed consent form detailing all pertinent aspects of the trial.

•1)Suffering from recently diagnosed or unmanaged medical conditions including but not limited to: diabetes, hyper/hypotension, cardiovascular disease, a gastrointestinal disease requiring regular use of medications, gallbladder disease, autoimmune disease, endocrine disease, acute or chronic pain condition, or cancer/malignancy
•2)Diagnosis of psychiatric or neurological conditions including but not limited to: any psychiatric disorder (other than mild-to-moderate depression and/or anxiety), neurological disease (Parkinson’s, Alzheimer’s disease, intracranial haemorrhage, head or brain injury),
•3)Regular medication intake including but not limited to anticholinergics, anti-epileptics, acetylcholinesterase inhibitors, antihistamines, benzodiazepines, opioids, or corticosteroids.
•4)Change in medication in the last 3 months or expectation to change during the study duration
•5)Currently taking saffron supplements
•6)In the last 6 months, commenced or changed dose of nutritional and/or herbal supplements that may impact on treatment outcome
•7)Current or 12-month history of illicit drug abuse
•8)Alcohol intake greater than 14 standard drinks per week
•9)Participation in any other clinical trial in the last 3 months
•10)Pregnant women, women who are breastfeeding or women who intend to fall pregnant.
•11)Any significant surgeries over the last year
•12)Overnight shift workers
•13)Planned major lifestyle change in the next 3 months

发起方

Clinical Research Australia