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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

87 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2013-02-28

Brief Summary

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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.

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Detailed Description

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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

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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B-Back® verum

Group Type EXPERIMENTAL

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

Intervention Type DIETARY_SUPPLEMENT

2 tablets/day after breakfast during 12 weeks

B-Back® placebo

Group Type PLACEBO_COMPARATOR

B-Back® placebo (without active compounds)

Intervention Type DIETARY_SUPPLEMENT

2 tablets/day after breakfast during 12 weeks

Interventions

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

2 tablets/day after breakfast during 12 weeks

Intervention Type DIETARY_SUPPLEMENT

B-Back® placebo (without active compounds)

2 tablets/day after breakfast during 12 weeks

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

30 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No