NCT01767922已完成3 期
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
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Bionov
- 入组人数
- 61
- 主要终点
- Perceived Stress : Change from base line in Cohen PSS 14 scale at V2 and V3
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
- •Score greater than 30 on the Cohen perceived stress scale PSS
- •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.
排除标准
- •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.
结局指标
主要结局
Perceived Stress : Change from base line in Cohen PSS 14 scale at V2 and V3
时间窗: Evaluation performed at inclusion day (V1), after 4 weeks at D28 (V2) and then at the end of study visit on D84 (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.
次要结局
- Evaluation of evolution of Physical fatigue(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 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 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 performed at inclusion day (V1), after 4 weeks at D28 (V2) and then at the end of study visit on D84 (V3).)
研究者
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