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

NCT07695870 — Not applicable, Completed, 120 participants, MiraxBioPharma

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

Registry	NCT07695870
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: triple, treatment
Enrollment	120 (Actual)
Sponsor	MiraxBioPharma (Industry)
Conditions	Jet Lag Disorder, Jet Lag, Jet Lag Type Insomnia, Cognition Improvement
Interventions	Fitoavia, Placebo, Questionnaire and Physical Exam, cognition tests (Dietary supplement, diagnostic test)
Dates	start 2025-10-01, primary completion 2025-12-31, completion 2026-04-30, first posted 2026-07-10, last updated 2026-07-10
Locations	1 site in Russia

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
treatment	Experimental	Dietary Supplement: Fitoavia; Diagnostic Test: Questionnaire and Physical Exam; Diagnostic Test: cognition tests	recieved active components for jet lag treatment
Control	Placebo comparator	Dietary Supplement: Placebo; Diagnostic Test: Questionnaire and Physical Exam; Diagnostic Test: cognition tests	resieved the same looking capsules without active components

Fitoavia (Dietary supplement), also known as Placebo, Questionaire, Cognition test, EQ-5D questionaire, Informed consent signing, Blood preasure measurement, Saturation, pulse: 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
Placebo (Dietary supplement), also known as questionarie, BPM, weight, tall,: Placebo contains no active components
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)

+Outcome measures

Primary outcomes

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 outcomes

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)

+Eligibility

Sex: All, ages: 18 Years to any, accepts healthy volunteers

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

+Locations (1)

Facility	City	Country	Status
MiraxBioPharma	Moscow	Russia