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Completed NCT07695870

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

Conditions: Jet Lag Disorder, Jet Lag, Jet Lag Type Insomnia, Cognition Improvement

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: Yes
Phase: NA
Enrollment: 120
Sponsor: MiraxBioPharma

Location: MiraxBioPharma Moscow

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.

Eligibility Criteria

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

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07695870). StuddyBuddy aggregates publicly available trial information.