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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Enrollment
61
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).
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.
Time frame: Evaluation performed at inclusion day (V1), after 4 weeks at D28 (V2) and then at the end of study visit on D84 (V3).
Evaluation of evolution of Physical fatigue
Evaluation performed by Prevost subjective fatigue scale and Ruffier test.
Time frame: Evaluation performed at inclusion day (V1), after 4 weeks at D28 (V2) and then at the end of study visit on D84 (V3).
Evaluation of evolution of Intellectual fatigue
Evaluation performed by Stroop test, Reverse Stroop test and 15-words Rey test.
Time frame: Evaluation performed at inclusion day (V1), after 4 weeks at D28 (V2) and then at the end of study visit on D84 (V3).
Evaluation of evolution of pain
Evaluation of subjects' perceived chronic pain (if existing), was performed using a simple visual analog scale (VAS).
Time frame: Evaluation performed at inclusion day (V1), after 4 weeks at D28 (V2) and then at the end of study visit on D84 (V3).
Evaluation of evolution of subject Quality of life
Evaluation of subjects' quality of life, was performed by using Quality of Life SF36 scale.
Time frame: Evaluation performed at inclusion day (V1), after 4 weeks at D28 (V2) and then at the end of study visit on D84 (V3).
Evaluation of evolution of subject Quality of life
Evaluation of subjects' quality of life, was performed by using Hamilton anxiety scale.
Time frame: Evaluation performed at inclusion day (V1), after 4 weeks at D28 (V2) and then at the end of study visit on D84 (V3).
Evaluation of evolution of subject Quality of life
Evaluation of subjects' quality of life, was performed by using Personnal stress profile questionnary.
Time frame: Evaluation performed at inclusion day (V1), after 4 weeks at D28 (V2) and then at the end of study visit on D84 (V3).
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