Evaluation of the Efficacy and Tolerance of B-Back® on the Burnout Syndrome. Double-blind, Randomized, Monocentric Trial With Two Parallel Groups (B-Back® Verum Versus B-Back® Placebo)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 87
- 试验地点
- 1
- 主要终点
- Change from baseline in Burnout Measure Short version (BMS-10) score at 12 weeks
研究概览
简要总结
The purpose of this study is to determine the efficacy and the tolerance of the food supplement B-Back®, containing α-casozepine, taurine, eleutherococcus senticosus and Extramel®, on the burnout syndrome.
详细描述
The burnout syndrome currently concern all the professional categories. In 2010 the WHO estimated that the three countries with the most important work-related depression are Unites States, Ukraine and France. The direct and indirect costs of work-related stress for the insurance program were not insignificant.
The purpose of this study is to determine the efficacy of the food supplement B-Back® proposed in order to improved the symptoms of the burnout syndrome : stress, fatigue, emotional imbalance, anxiety, sleep, etc.
The main objective is to determine the efficacy of B-Back® on the symptoms suggestive of the burnout syndrome by using the Burnout Measure Short version (BMS-10). The others objectives were to evaluate the tolerance of the product, to evaluate the efficacy of B-Back® on the symptoms suggestive of the burnout syndrome by using the Maslach Burnout Inventory, depression, and the global quality of professional and family life, sleep,and fatigue (energy).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •males and females outpatients aged 30-65 years old
- •practicing professionals in contact with patients, students,...
- •symptoms suggestive of burnout syndrome
- •minimum score to the BMS-10 = 4
- •able to understand the sdudy documents
- •agreeing to go to dates of controls
- •able to give informed consent
- •affiliated to a French national insurance program
排除标准
- •current anxiolytic or antidepressant treatment
- •allergy known about one of the components of the food complement in the study
- •intolerance in the lactose and in the proteins of milk
- •pregnancy or feeding
- •progressive pathology involving life-threatening during study
- •professional on sick leave
- •cancer not stabilized for at least five years or considered as not recovered
- •subjects deprived of liberty court decision
- •subjects in the psychic incapacity to understand the constraints of the study
结局指标
主要结局
Change from baseline in Burnout Measure Short version (BMS-10) score at 12 weeks
时间窗: baseline and after 12 weeks
次要结局
- Change from baseline in BMS-10 score at 6 weeks(baseline and after 6 weeks)
- Change from baseline in Maslach Burnout Inventory score at 6 weeks(baseline and after 6 weeks)
- Change from baseline in Maslach Burnout Inventory score at 12 weeks(baseline and after 12 weeks)
- Change from baseline in the evaluation of the tolerance (excellent, good, average, bad) at 6 weeks(baseline and after 6 weeks)
- Change from baseline in the evaluation of the tolerance (excellent, good, average, bad) at 12 weeks(baseline and after 12 weeks)
- Change from baseline in Beck Depression Inventory score at 6 weeks(baseline and after 6 weeks)
- Change from baseline in Beck Depression Inventory score at 12 weeks(baseline and after 12 weeks)
- Change from baseline in visual analogic scales for the global quality of the professional, family life, sleep, fatigue at 6 weeks(baseline and after 6 weeks)
- Change from baseline in visual analogic scales for the global quality of the professional, family life, sleep,fatigue at 12 weeks(baseline and after 12 weeks)
研究者
Alain Jacquet
MD
Université Victor Segalen Bordeaux 2