Double-blind, Randomized, Placebo-controlled Scientific Study of the Comparative Effectiveness of Fitoavia Dietary Supplement in People With Dyssynchrony Syndrome.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- decreased summary of jet lag symphtoms
研究概览
简要总结
Purpose of the study: Evaluation of the effects of dietary supplement Fitoavia in people with dyssynchrony
Objectives of the study:
- Assessment of the condition of patients with jet lag of 4 hours or more
- Determination of the day of normalization of the circadian rhythm in each group
- Assessing the quality of life of patients.
- Assessment of the economic effectiveness of the therapy performed
- Evaluation of the results of daily software testing for "staff" of at least 12 people from each group Randomization Block randomization with stratification. Randomization sheets will be provided prior to the start of the study.
Sample size Total number of patients included in the study: up to 120.
Study groups Group 2 - at least 60 patients in each group (Fitoavia/Placebo) with stratification within each group:
Group 1, patients receiving: Fitoavia. Group 2 patients who received: Placebo. Stratification implies uniform inclusion of patients according to the amount of jet lag.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •• Voluntarily and personally signed informed consent form to participate in the study, before any of the research procedures.
- •Men and women over 18 years of age who have a time difference of more than four hours from their place of primary residence;
- •Confirmed flight in less than 24 hours
- •Previous adaptation to the new regimen for 3 or more days according to the screening questionnaire
- •Presence of three or more symptoms of jet lag on the screening questionnaire with a score above 5
排除标准
- •• Currently taking adaptogens
结局指标
主要结局
decreased summary of jet lag symphtoms
时间窗: From enrollment to the end of treatment (day 0 - day 7)
day if symphtom decreased (daily measurement)
sleep duration
时间窗: Everyday from baseline, until the end of the study (day 0 - day 7)
each day patients will check the sleep duration time in hours and minutes
次要结局
- Questionairy level(from enrolment to the end of the study (day 0 - day 7))
- Cognition level(From enrollment to the end of the treatment (day 0 - day 7))