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

Study Overview
=================
Brief 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).

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)

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

Intervention / Treatment
-----------------
* Dietary Supplement: Dietary supplement : B-Back® (α-casozepine, taurine, eleutherococcus senticosus, Extramel)
* Dietary Supplement: B-Back® placebo (without active compounds)


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: B-Back® verum<br> | Dietary Supplement: Dietary supplement : B-Back® (α-casozepine, taurine, eleutherococcus senticosus, Extramel)<br>* 2 tablets/day after breakfast during 12 weeks<br>|
| Placebo Comparator: B-Back® placebo<br> | Dietary Supplement: B-Back® placebo (without active compounds)<br>* 2 tablets/day after breakfast during 12 weeks<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Burnout Measure Short version (BMS-10) score at 12 weeks |  | baseline and after 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in BMS-10 score at 6 weeks |  | baseline and after 6 weeks | 
| Change from baseline in Maslach Burnout Inventory score at 6 weeks |  | baseline and after 6 weeks | 
| Change from baseline in Maslach Burnout Inventory score at 12 weeks |  | baseline and after 12 weeks | 
| Change from baseline in the evaluation of the tolerance (excellent, good, average, bad) at 6 weeks |  | baseline and after 6 weeks | 
| Change from baseline in the evaluation of the tolerance (excellent, good, average, bad) at 12 weeks |  | baseline and after 12 weeks | 
| Change from baseline in Beck Depression Inventory score at 6 weeks |  | baseline and after 6 weeks | 
| Change from baseline in Beck Depression Inventory score at 12 weeks |  | 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 |  | 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 |  | baseline and after 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Burnout syndrome, Depression work-related, Food supplement