Skip to main content
OpenTrials
Completed

NCT Number: NCT07695870

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Jet Lag Disorder Chronobiology Disorders Cognition Improvement Dyssomnias Jet Lag Jet Lag Syndrome Jet Lag Type Insomnia Mental Disorders Nervous System Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Disorders, Circadian Rhythm Sleep Wake Disorders Travel-Related Illness

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

MiraxBioPharma

Moscow, Russia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fitoavia

Dietary 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

Other names: Placebo, Questionaire, Cognition test, EQ-5D questionaire, Informed consent signing, Blood preasure measurement, Saturation, pulse

Placebo

Dietary Supplement

Placebo contains no active components

Other names: questionarie, BPM, weight, tall,

Questionnaire and Physical Exam

Diagnostic Test

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

cognition tests

Diagnostic Test

tests on spesial testing platform (Tests on the PC)

Primary outcomes

  1. decreased summary of jet lag symphtoms

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

    day if symphtom decreased (daily measurement)

  2. sleep duration

    Time frame: 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 outcomes

  1. Questionairy level

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

    EQ-5D daily level

  2. Cognition level

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

    Tests on the PC (makes daily)

Sponsors and collaborators

Lead sponsor

MiraxBioPharma

Industry

Registry information

Official study title

Double-blind, Randomized, Placebo-controlled Scientific Study of the Comparative Effectiveness of Fitoavia Dietary Supplement in People With Dyssynchrony Syndrome.

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Jul 10, 2026
Registry last updated
Jul 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.