Cognition Improvement, Jet Lag, Jet Lag Disorder, Jet Lag Type Insomnia
Conditions
Keywords
let lag, dyssynchrony syndrome
Brief summary
Purpose of the study: Evaluation of the effects of dietary supplement Fitoavia in people with dyssynchrony Objectives of the study: 1. Assessment of the condition of patients with jet lag of 4 hours or more 2. Determination of the day of normalization of the circadian rhythm in each group 3. Assessing the quality of life of patients. 4. Assessment of the economic effectiveness of the therapy performed 5. 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.
Interventions
DIETARY_SUPPLEMENTFitoavia
Interventional: participants are assigned prospectively to an intervention or interventions according to a protocol to evaluate the effect of the intervention(s) on biomedical or other health related outcomes; EQ-5D questionaire, placebo group, cognition tests
DIETARY_SUPPLEMENTPlacebo
Placebo contains no active components
DIAGNOSTIC_TESTQuestionnaire and Physical Exam
EQ-5D, measurements of weight, BMI, blood pressuarem temperature, oxigenation, sleep time duration, AE.
DIAGNOSTIC_TESTcognition tests
tests on spesial testing platform (Tests on the PC)
Sponsors
MiraxBioPharma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* • 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
Exclusion criteria
* • Currently taking adaptogens
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| decreased summary of jet lag symphtoms | From enrollment to the end of treatment (day 0 - day 7) | day if symphtom decreased (daily measurement) |
| sleep duration | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Questionairy level | from enrolment to the end of the study (day 0 - day 7) | EQ-5D daily level |
| Cognition level | From enrollment to the end of the treatment (day 0 - day 7) | Tests on the PC (makes daily) |
Countries
Russia
Outcome results
None listed