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| ID | Type | Description | Link |
|---|---|---|---|
| e530 | Other Identifier | Clinical Pharmacology Department of University Victor Segalen Bordeaux 2 |
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| Name | Class |
|---|---|
| Nanox International Laboratory (Belgique) | UNKNOWN |
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The purpose of this study is to determine the efficacy and the tolerance of the food supplement B-BackĀ®, containing Ī±-casozepine, taurine, eleutherococcus senticosus and ExtramelĀ®, on the burnout syndrome.
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-BackĀ® 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-BackĀ® 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-BackĀ® 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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| B-BackĀ® verum | Experimental |
| |
| B-BackĀ® placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dietary supplement : B-BackĀ® (Ī±-casozepine, taurine, eleutherococcus senticosus, Extramel) | Dietary Supplement | 2 tablets/day after breakfast during 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in Burnout Measure Short version (BMS-10) score at 12 weeks | baseline and after 12 weeks |
| 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 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nicholas Moore, MD, PhD | UniversitƩ Victor Segalen Bordeaux 2 | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cinical Pharmacology Department - UniversitƩ Victor Segalen Bordeaux 2 | Bordeaux | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Malach-Pines A. The Burnout Measure Short version (BMS). International Journal of Stress Management. 2005;12:78-88 | ||
| Background | Benezech M, Mullens E, Lalonde R, Desor D, Messaoudi M. Un anxiolytique naturel : l'hydrolysat trypsique de casĆ©ine alpha-s1 de lait bovin. Son intĆ©rĆŖt en mĆ©decine humaine et vĆ©tĆ©rinaire. Annales MĆ©dico-Psychologiques. 2009;167:605-10. | ||
| 17136040 | Background | Kim JH, Desor D, Kim YT, Yoon WJ, Kim KS, Jun JS, Pyun KH, Shim I. Efficacy of alphas1-casein hydrolysate on stress-related symptoms in women. Eur J Clin Nutr. 2007 Apr;61(4):536-41. doi: 10.1038/sj.ejcn.1602553. Epub 2006 Nov 29. | |
| 19754931 |
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| B-BackĀ® placebo (without active compounds) | Dietary Supplement | 2 tablets/day after breakfast during 12 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 |
| Background |
| Milesi MA, Lacan D, Brosse H, Desor D, Notin C. Effect of an oral supplementation with a proprietary melon juice concentrate (Extramel) on stress and fatigue in healthy people: a pilot, double-blind, placebo-controlled clinical trial. Nutr J. 2009 Sep 15;8:40. doi: 10.1186/1475-2891-8-40. |
| 16540157 | Background | Kong WX, Chen SW, Li YL, Zhang YJ, Wang R, Min L, Mi X. Effects of taurine on rat behaviors in three anxiety models. Pharmacol Biochem Behav. 2006 Feb;83(2):271-6. doi: 10.1016/j.pbb.2006.02.007. Epub 2006 Mar 15. |
| Background | Facchinetti F, Neri I, Tarabusi M. Eleutherococcus senticosus reduces cardi-ovascular stress response in healthy subjects: a randomized, placebo-controlled trial. Stress and Health. 2002;18:11-7. |
| 14971626 | Background | Hartz AJ, Bentler S, Noyes R, Hoehns J, Logemann C, Sinift S, Butani Y, Wang W, Brake K, Ernst M, Kautzman H. Randomized controlled trial of Siberian ginseng for chronic fatigue. Psychol Med. 2004 Jan;34(1):51-61. doi: 10.1017/s0033291703008791. |
| ID | Term |
|---|---|
| D000077062 | Burnout, Psychological |
| ID | Term |
|---|---|
| D013315 | Stress, Psychological |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D013654 | Taurine |
| C000713177 | Siberian ginseng root |
| C545282 | Extramel |
| ID | Term |
|---|---|
| D017738 | Alkanesulfonic Acids |
| D000473 | Alkanes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
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