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

Université Victor Segalen Bordeaux 2

Status: Completed

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

Treatments: Dietary Supplement: Dietary supplement : B-Back® (α-casozepine, taurine, eleutherococcus senticosus, Extramel); Dietary Supplement: B-Back® placebo (without active compounds)

Study type: Interventional

Funder types: Other

Identifiers

NCT01599169

ID-RCB : 2012 - A00096 - 37

e530 (Other Identifier)

Details and patient eligibility

About

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.

Full 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).

Enrollment: 87 patients

Sex: All

Ages: 30 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

87 participants in 2 patient groups, including a placebo group

B-Back® verum

Experimental group

Treatment:

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

B-Back® placebo

Placebo Comparator group

Treatment:

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