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Completed

NCT Number: NCT01599169

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

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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Key information

Conditions

Efficacy and Tolerance of B-Back® on the Burnout Syndrome Behavior Behavioral Symptoms Burnout, Psychological Stress, Psychological

Age range

30 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cinical Pharmacology Department - Université Victor Segalen Bordeaux 2

Bordeaux, France

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Dietary Supplement

2 tablets/day after breakfast during 12 weeks

B-Back® placebo (without active compounds)

Dietary Supplement

2 tablets/day after breakfast during 12 weeks

Primary outcomes

  1. Change from baseline in Burnout Measure Short version (BMS-10) score at 12 weeks

    Time frame: baseline and after 12 weeks

Secondary outcomes

  1. Change from baseline in BMS-10 score at 6 weeks

    Time frame: baseline and after 6 weeks

  2. Change from baseline in Maslach Burnout Inventory score at 6 weeks

    Time frame: baseline and after 6 weeks

  3. Change from baseline in Maslach Burnout Inventory score at 12 weeks

    Time frame: baseline and after 12 weeks

  4. Change from baseline in the evaluation of the tolerance (excellent, good, average, bad) at 6 weeks

    Time frame: baseline and after 6 weeks

  5. Change from baseline in the evaluation of the tolerance (excellent, good, average, bad) at 12 weeks

    Time frame: baseline and after 12 weeks

  6. Change from baseline in Beck Depression Inventory score at 6 weeks

    Time frame: baseline and after 6 weeks

  7. Change from baseline in Beck Depression Inventory score at 12 weeks

    Time frame: baseline and after 12 weeks

  8. Change from baseline in visual analogic scales for the global quality of the professional, family life, sleep, fatigue at 6 weeks

    Time frame: baseline and after 6 weeks

  9. Change from baseline in visual analogic scales for the global quality of the professional, family life, sleep,fatigue at 12 weeks

    Time frame: baseline and after 12 weeks

Sponsors and collaborators

Lead sponsor

Université Victor Segalen Bordeaux 2

Other

Collaborators

  • Nanox International Laboratory (Belgique)

Registry information

Official study 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)

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
May 15, 2012
Registry last updated
Apr 23, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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