ACTRN12621001551886已完成未知
Examining the efficacy and safety of a novel standardised Ashwagandha (Withania Somnifera) root extract in overweight middle-to-older age adults experiencing high stress and fatigue: a randomised, double-blind, placebo-controlled trial.
Clinical Research Australia0 个研究点目标入组 120 人开始时间: 2021年11月15日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 40 Years 至 75 Years（—）
- 性别
- All
入选标准
- •1)Healthy males and females aged between 40 and 75 years
- •2)Subjective report of low energy by answering ‘yes’ to the following question: Do you experience low energy or fatigue?
- •3)Currently experiencing high stress (as determined by a PSS scale score of 14 or higher)
- •4)A score of 9 or more on the PROMIS-29 fatigue subscale score
- •5)Stressor/anxiety has been present for greater than a month
- •6)Non-smoker
- •7)BMI between 25 and 35 kg/m2
- •8)Medication free over the previous 3 months
- •9)No plan to commence new treatments over the study period
- •10)No plan to change diet or physical activity or other significant lifestyle changes over the study period
- •11)Understand, willing, and able to comply with all study procedures
- •12)Willing to provide a personally signed and dated informed consent form detailing all pertinent aspects of the trial.
排除标准
- •1)Anticipated major stressor, change or medical procedure occurring during the study period likely to affect psychological or physical status
- •2)Blood profile (comprising complete blood count, liver function test, renal function test, and thyroid-stimulating hormone) containing elevated markers suggestive of a clinical condition/ disease and requiring further medical assessment.
- •3)Suffering from a diagnosed medical condition including but not limited to: diabetes, hyper/hypotension, cardiovascular disease, a gastrointestinal disease requiring regular use of medications, gallbladder disease/gallstones/biliary disease, autoimmune disease, endocrine disease, renal disease, hepatic disease, genital anatomical deformities, abnormal secondary sexual characteristics, spinal cord injury, benign prostatic hypertrophy, acute genitourinary disorder or history of genital surgery, acute or chronic pain condition, or cancer/malignancy
- •4)Diagnosis of neurological or psychiatric conditions including but not limited to: psychiatric disorder (other than mild-to-moderate depression or anxiety), neurological disease (Parkinson’s, Alzheimer’s disease, intracranial haemorrhage, head or brain injury
- •5)Diagnosed erectile dysfunction or any physical disability that may limit sexual function
- •6)Taking vitamins or herbal supplements that are reasonably expected to influence study measures
- •7)Current or 12-month history of illicit drug abuse
- •8)Regular medication intake including but not limited to anticholinergics, acetylcholinesterase inhibitors, testosterone replacement therapy, levodopa, calcipotriene, or steroid medications
- •9)Change in medication in the last 3 months or an expectation to change during the study duration
- •10)Alcohol intake greater than 14 standard drinks per week
- •11)Pregnant women, women who are breastfeeding or women who intended to fall pregnant.
- •12)Any significant surgeries over the last year
- •13)History of hypersensitivity to herbs, spices, or dietary supplement
- •14)Planned major lifestyle change in the next 3 months
- •15)Participation in any other clinical trial in the last 3 months
研究者
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