A Study on the Effectiveness of a Dietary Supplement FitoAvia for Jet Lag

MiraxBioPharma120 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

120

Conditions

Jet Lag Disorder Jet Lag Jet Lag Type Insomnia

Interventions

FitoaviaDIETARY_SUPPLEMENT

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

PlaceboDIETARY_SUPPLEMENT

Placebo contains no active components

Questionnaire and Physical ExamDIAGNOSTIC_TEST

EQ-5D, measurements of weight, BMI, blood pressuarem temperature, oxigenation, sleep time duration, AE.

cognition testsDIAGNOSTIC_TEST

tests on spesial testing platform (Tests on the PC)

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

decreased summary of jet lag symphtoms

day if symphtom decreased (daily measurement)

Time frame: From enrollment to the end of treatment (day 0 - day 7)

sleep duration

each day patients will check the sleep duration time in hours and minutes

Time frame: Everyday from baseline, until the end of the study (day 0 - day 7)

Secondary Outcomes

Questionairy level

EQ-5D daily level

Time frame: from enrolment to the end of the study (day 0 - day 7)

Cognition level

Tests on the PC (makes daily)

Time frame: From enrollment to the end of the treatment (day 0 - day 7)