ACTRN12623001231639招募中Unknown
A further examination of the short-term anxiolytic effects of an Echinacea extract (EP107)in adults experiencing increased anxiety: A randomised, double-blind, placebo-controlledtrial
Clinical Research Australia0 个研究点目标入组 80 人开始时间: 2023年11月30日最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 发起方
- 入组人数
- 80
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
- 18 Years 至 80 Years（—）
- 性别
- All
入选标准
- •1. Generally, healthy adults (male and female) aged 18 to 80 years
- •2. Currently self-reporting experiencing high stress and/or anxiety
- •3. A score of 45 or higher on both the State-Trait Anxiety Inventory (STAI), State and Trait Subscale Scores at both screening and baseline
- •4. Non-smoker
- •5. BMI between 18 and 30 kg/m2
- •6. No plan to commence new treatments over the study period
- •7. Understand, willing and able to comply with all study procedures
- •8. Willing to provide a personally signed and dated informed consent form detailing all pertinent aspects of the trial.
排除标准
- •1. Currently receiving, or in the previous 3 months, psychological intervention for anxiety or depression.
- •2. Diagnosis of psychiatric or neurological conditions including but not limited to: any psychiatric or neurological disease (Parkinson’s, Alzheimer’s disease, intracranial haemorrhage, head or brain injury)
- •3. Suffering from recently diagnosed or unmanaged medical conditions including but not limited to: diabetes, hyper/hypotension, cardiovascular disease, gastrointestinal disease requiring regular use of medications, gallbladder disease, autoimmune disease, endocrine disease, acute or chronic pain condition, or cancer/malignancy
- •4. Regular medication intake including but not limited to anticholinergics, anti-epileptics, antihistamines, benzodiazepines, opioids, or corticosteroids.
- •5. Change in medication in the last 3 months or expectation to change during the study duration
- •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 Any significant surgeries over the last year
- •11. Overnight shift workers
- •12. Pregnant, breastfeeding or women who plan to fall pregnant 3 months after the end of the study.
- •13. Planned major lifestyle change in the next 2 months
- •14. Known allergy to Echinacea, chamomile or sunflower oil.
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