Efficacy and Tolerance of B-Back® on the Burnout Syndrome Clinical Trial
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)
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.
| Status | Completed |
| Enrollment | 87 |
| Est. completion date | February 2013 |
| Est. primary completion date | February 2013 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 30 Years to 65 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)
| Country | Name | City | State |
|---|---|---|---|
| France | Cinical Pharmacology Department - Université Victor Segalen Bordeaux 2 | Bordeaux |
| Lead Sponsor | Collaborator |
|---|---|
| Université Victor Segalen Bordeaux 2 | Nanox International Laboratory (Belgique) |
France,
Benezech M, Mullens E, Lalonde R, Desor D, Messaoudi M. Un anxiolytique naturel : l'hydrolysat trypsique de caséine alpha-s1 de lait bovin. Son intérêt en médecine humaine et vétérinaire. Annales Médico-Psychologiques. 2009;167:605-10.
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.
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. — View Citation
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. Epub 2006 Nov 29. — View Citation
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. Epub 2006 Mar 15. — View Citation
Malach-Pines A. The Burnout Measure Short version (BMS). International Journal of Stress Management. 2005;12:78-88
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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change from baseline in Burnout Measure Short version (BMS-10) score at 12 weeks | baseline and after 12 weeks | No | |
| Secondary | Change from baseline in BMS-10 score at 6 weeks | baseline and after 6 weeks | No | |
| Secondary | Change from baseline in Maslach Burnout Inventory score at 6 weeks | baseline and after 6 weeks | No | |
| Secondary | Change from baseline in Maslach Burnout Inventory score at 12 weeks | baseline and after 12 weeks | No | |
| Secondary | Change from baseline in the evaluation of the tolerance (excellent, good, average, bad) at 6 weeks | baseline and after 6 weeks | No | |
| Secondary | Change from baseline in the evaluation of the tolerance (excellent, good, average, bad) at 12 weeks | baseline and after 12 weeks | No | |
| Secondary | Change from baseline in Beck Depression Inventory score at 6 weeks | baseline and after 6 weeks | No | |
| Secondary | Change from baseline in Beck Depression Inventory score at 12 weeks | baseline and after 12 weeks | No | |
| Secondary | 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 | No | |
| Secondary | 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 | No |