Efficacy and Tolerance of B-Back® on the Burnout Syndrome Clinical Trial
Official title:
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)
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).
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)