NCT01599169

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)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 87 (actual)
• Sponsor: Université Victor Segalen Bordeaux 2 · Academic / Other
• Sex: All
• Age: 30 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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).

Conditions

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2012-05-01
• Primary completion: 2013-02-01
• Completion: 2013-02-01
• First posted: 2012-05-15
• Last updated: 2013-04-23

Locations

1 site across 1 country: France