The Effectiveness of a Caralluma Fimbriata Extract on Stress, Sleep and Neurotransmitters, a Randomised Placebo-controlled Double-blind Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 129
- 试验地点
- 1
- 主要终点
- Change in stress as assessed by Perceived Stress Scale (PSS)
研究概览
简要总结
This is a double blind, randomised, placebo-controlled clinical trial aiming to assess the effectiveness of Caralluma fimbriata on stress, sleep and neurotransmitters in a healthy adult population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults aged 18 years and above
- •Self-reporting Stress
- •Able to provide informed consent
- •Agree not to change current diet and exercise program while enrolled in this trial
- •Agree not to undertake another clinical trial while enrolled in this trial
排除标准
- •Unstable or serious illness (e.g. Serious mood disorders, neurological disorders such as MS, kidney disease, liver disease, heart conditions, diabetes, thyroid gland dysfunction)*
- •Current malignancy (excluding BCC) or chemotherapy and radiotherapy treatment for malignancy within the previous 2 years
- •Receiving/prescribed coumadin (Warfarin), heparin, dalteparin, enoxaparin or other anticoagulation therapy
- •Receiving treatment for anxiety, or taking supplements# for anxiety or sleep conditions such as saffron, valerian, etc.
- •Active smokers, nicotine use, alcohol or drug (prescription or illegal substances) abuse
- •Chronic past and/or current alcohol use (>14 alcoholic drinks week)
- •Allergic to any of the ingredients in the active or placebo formula
- •Known pregnant or lactating woman
- •Any condition which in the opinion of the investigator makes the participant unsuitable for inclusion
- •Participants who have participated in any other related clinical study during the past 1 month
- •History of infection in the month prior to the study
- •An unstable illness is any illness that is currently not being treated with a stable dose of medication or is fluctuating in severity. A serious illness is a condition that carries a risk of mortality, negatively impacts quality of life and daily function and/or is burdensome in symptoms and/or treatments.
- •Potential participants that are taking supplements that would result in their exclusion must wait a 4-week washout period prior to commencing the study.
研究组 & 干预措施
Caralluma fimbriata
Caralluma fimbriata in capsule form - taken as a 500mg dose (two 250mg capsules) twice daily, morning and evening with food.
干预措施: Caralluma Fimbriata (Drug)
Placebo comparator capsule - Microcrystalline cellulose
A comparator capsule taken as a 500mg dose (two 250mg capsules) twice daily, morning and evening with food.
干预措施: Placebo comparator - Microcrystalline cellulose (Drug)
结局指标
主要结局
Change in stress as assessed by Perceived Stress Scale (PSS)
时间窗: Baseline prior to commencement of study product, Week 4 and Week 8
Change in stress as assessed by Perceived Stress Scale (PSS) - Score range 0-40, Higher scores indicate higher perceived stress.
Change in stress as assessed by Salivary Cortisol levels
时间窗: Baseline prior to commencement of study product, Week 4 and Week 8
Change in stress as assessed by Salivary Cortisol levels through assay
次要结局
- Change in stress and mood as assessed by the Profile of Mood States (POMS) scale(Baseline prior to commencement of study product, Week 4 and Week 8)
- Change in Neurotransmitters as assessed by pathology(Baseline prior to commencement of study product, Week 4 and Week 8)
- Change in sleep as measured by the Restorative Sleep Questionnaire (RSQ)(Baseline prior to commencement of study product, Week 4 and Week 8)
- Change in stress and mood as assessed by The Depression, Anxiety Stress Scale -21 (DASS-21)(Baseline prior to commencement of study product, Week 4 and Week 8)
- Change in sleep as assessed by the Pittsburgh Sleep Quality Index (PSQI)(Baseline prior to commencement of study product, Week 4 and Week 8)