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.
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
DOUBLE
Enrollment
87
2 tablets/day after breakfast during 12 weeks
2 tablets/day after breakfast during 12 weeks
Cinical Pharmacology Department - Université Victor Segalen Bordeaux 2
Bordeaux, France
Change from baseline in Burnout Measure Short version (BMS-10) score at 12 weeks
Time frame: baseline and after 12 weeks
Change from baseline in BMS-10 score at 6 weeks
Time frame: baseline and after 6 weeks
Change from baseline in Maslach Burnout Inventory score at 6 weeks
Time frame: baseline and after 6 weeks
Change from baseline in Maslach Burnout Inventory score at 12 weeks
Time frame: baseline and after 12 weeks
Change from baseline in the evaluation of the tolerance (excellent, good, average, bad) at 6 weeks
Time frame: baseline and after 6 weeks
Change from baseline in the evaluation of the tolerance (excellent, good, average, bad) at 12 weeks
Time frame: baseline and after 12 weeks
Change from baseline in Beck Depression Inventory score at 6 weeks
Time frame: baseline and after 6 weeks
Change from baseline in Beck Depression Inventory score at 12 weeks
Time frame: 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
Time frame: 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
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Time frame: baseline and after 12 weeks