Trial | NCT01599169  Report issue

Title

Evaluation of the Efficacy and Tolerance of B-Back® on the Burnout Syndrome
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)

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    87
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 Started
May 31
2012
Primary Completion
Feb 28
2013
Study Completion
Feb 28
2013
Last Update
Apr 23
2013
Estimate

Dietary Supplement Dietary supplement : B-Back® (α-casozepine, taurine, eleutherococcus senticosus, Extramel)

2 tablets/day after breakfast during 12 weeks

Dietary Supplement B-Back® placebo (without active compounds)

2 tablets/day after breakfast during 12 weeks

B-Back® placebo Placebo Comparator

B-Back® verum Experimental

Criteria 

Inclusion Criteria:

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

Exclusion Criteria:

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
No Results Posted