Multicentre, Double-blind Study Versus Placebo on Impact and Safety of Extramel® 140 IU on Perceived Stress, Physical and Intellectual Fatigue, Pain Perception if Present, and the Impact on the Quality of Life

Pain Clinical Trial

— Ex Stress II  

Official title:

Multicentre, Double-blind Study Versus Placebo on the Impact and Safety of the Daily Administration of Extramel® 140 IU for 12 Weeks on Perceived Stress, Physical and Intellectual Fatigue, Pain Perception, if Present, and the Impact on the Quality of Life of 70 Subjects Included, of Which 60 That Can be Evaluated

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01767922
• Other study ID #: SE-ISO-2007-01
• Status: Completed
• Phase: Phase 3
• First received: January 11, 2013
• Last updated: January 17, 2013
• Start date: September 2008
• Est. completion date: September 2009

Study information

• Verified date: January 2013
• Source: Bionov
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)France: Direction Générale de la Santé
• Study type: Interventional

Clinical Trial Summary

Objectives of this Multicentre, double-blind study versus placebo were to evaluate impact and safety of the daily administration of Extramel® 140 IU SOD for 12 weeks on perceived stress, physical and intellectual fatigue, pain perception, if present, and the impact on the quality of life of 70 subjects included with 60 that can be evaluated.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: September 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 30 Years to 65 Years

Eligibility

Inclusion Criteria:

• Male or female person using an effective contraceptive method, with a negative urine pregnancy test on the inclusion visit for the women of reproductive age.

• Older than 30 years and younger than 65 years

• BMI = 30

• Score greater than 30 on the Cohen perceived stress scale PSS 14.

• Score between 5 and 20 in the Hamilton anxiety scale (excluding the limits).

• Presenting an impact of stress on at least one of the following domains.

• pain domain with a score greater than 20 millimeters measured on the visual pain evaluation scale,

• physical condition domain with a score greater than 50 on the Prevost subjective fatigue scale,

• the psychical condition domain with a global score below 160 in the Stroop test and the reverse Stroop test.

• Stable professional activity since at least 1 year.

• Completely healthy on the day of inclusion, and not taking any medicinal product or dietary supplement with an anti-stress or anti-pain objective.

• Not taking any herbal tea or drink with an anti-stress or anti-pain objective.

• Accepting not to modify his/her dietary habits.

• Having given his/her free, informed and express consent.

• Capable of understanding the nature of the objectives, the consequences of the study and accepting to comply with the protocol requirements.

• Affiliated with a social security insurance or beneficiary of such an insurance system.

Exclusion Criteria:

• Subject presenting an acute pain or pain considered to be incapacitating by the patient him/herself or the observer physician.

• Subject currently under a chronic or acute treatment indicated for stress or anxiety, irrespective of the treatment.

• Subject currently under a chronic or acute treatment indicated for pain problems, irrespective of the treatment.

• Pregnant and/or breast-feeding women.

• Any person who does not satisfy by definition the inclusion criteria.

• Adult protected by the law.

• Any history of psychiatric disease.

• Any pathology in progress or active in the previous month.

• Any administration of a dietary supplement in progress or in the previous month.

• Any subject who within the 3 months following inclusion is likely to experience a major modification of his/her life rhythm (For example marriage, birth of a child, scheduled hospitalization, important exam, etc.) this is left to the discretion of the investigator.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Fatigue
• Life Stress
• Pain
• Quality of Life

Intervention

Dietary Supplement:
• Extramel 10 mg - 140 UI SOD
Subjects took one capsule of Extramel® 140 IU, or its corresponding placebo, daily over 12 weeks. Each volunteer was seen for the 3 visits: visit V1, so-called inclusion visit (D0), visit V2 at 28 days, tolerance of +/- 3 days, (D28) and visit V3 at 84 days, tolerance of +/- 3 days, (D84).
• Placebo - Excipient only

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Bionov	SEPPIC

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Evaluation of safety	Assessment of the safety performed by analysis of adverse events that occurred throughout the study.	Global safty evaluation performed at the end of study.	Yes
Primary	Perceived Stress : Change from base line in Cohen PSS 14 scale at V2 and V3	Evaluation performed by Cohen PSS 14 scale. It should be noted that in order to be included the patient had to present a minimum score of 30 on the Cohen scale.	Evaluation performed at inclusion day (V1), after 4 weeks at D28 (V2) and then at the end of study visit on D84 (V3).	No
Secondary	Evaluation of evolution of Physical fatigue	Evaluation performed by Prevost subjective fatigue scale and Ruffier test.	Evaluation performed at inclusion day (V1), after 4 weeks at D28 (V2) and then at the end of study visit on D84 (V3).	No
Secondary	Evaluation of evolution of Intellectual fatigue	Evaluation performed by Stroop test, Reverse Stroop test and 15-words Rey test.	Evaluation performed at inclusion day (V1), after 4 weeks at D28 (V2) and then at the end of study visit on D84 (V3).	No
Secondary	Evaluation of evolution of pain	Evaluation of subjects' perceived chronic pain (if existing), was performed using a simple visual analog scale (VAS).	Evaluation performed at inclusion day (V1), after 4 weeks at D28 (V2) and then at the end of study visit on D84 (V3).	No
Secondary	Evaluation of evolution of subject Quality of life	Evaluation of subjects' quality of life, was performed by using Quality of Life SF36 scale.	Evaluation performed at inclusion day (V1), after 4 weeks at D28 (V2) and then at the end of study visit on D84 (V3).	No
Secondary	Evaluation of evolution of subject Quality of life	Evaluation of subjects' quality of life, was performed by using Hamilton anxiety scale.	Evaluation performed at inclusion day (V1), after 4 weeks at D28 (V2) and then at the end of study visit on D84 (V3).	No
Secondary	Evaluation of evolution of subject Quality of life	Evaluation of subjects' quality of life, was performed by using Personnal stress profile questionnary.	Evaluation performed at inclusion day (V1), after 4 weeks at D28 (V2) and then at the end of study visit on D84 (V3).	No