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

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

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 Overview

• Status: Completed
• Conditions: Jet Lag; Jet Lag Disorder; Jet Lag Type Insomnia; Cognition Improvement
• Intervention / Treatment: Dietary supplement: Fitoavia; Diagnostic test: Questionnaire and Physical Exam; Diagnostic test: cognition tests; Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Russia
  • Moscow, Russia
    • MiraxBioPharma

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: treatment; recieved active components for jet lag treatment	Dietary supplement: Fitoavia; 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; Saturation; pulse; Questionaire; Cognition test; EQ-5D questionaire; Informed consent signing; Blood preasure measurement; Diagnostic test: Questionnaire and Physical Exam; EQ-5D, measurements of weight, BMI, blood pressuarem temperature, oxigenation, sleep time duration, AE.; Diagnostic test: cognition tests; tests on spesial testing platform (Tests on the PC)
Placebo Comparator: Control; resieved the same looking capsules without active components	Diagnostic test: Questionnaire and Physical Exam; EQ-5D, measurements of weight, BMI, blood pressuarem temperature, oxigenation, sleep time duration, AE.; Diagnostic test: cognition tests; tests on spesial testing platform (Tests on the PC); Dietary supplement: Placebo; Placebo contains no active components; Other Names: questionarie, BPM, weight, tall,

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
decreased summary of jet lag symphtoms	day if symphtom decreased (daily measurement)	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	Everyday from baseline, until the end of the study (day 0 - day 7)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Questionairy level	EQ-5D daily level	from enrolment to the end of the study (day 0 - day 7)
Cognition level	Tests on the PC (makes daily)	From enrollment to the end of the treatment (day 0 - day 7)

Collaborators and Investigators

• Sponsor: MiraxBioPharma

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2025
• Primary Completion (Actual): December 31, 2025
• Study Completion (Actual): April 30, 2026

Study Registration Dates

• First Submitted: May 27, 2026
• First Submitted That Met QC Criteria: July 8, 2026
• First Posted (Actual): July 10, 2026

Study Record Updates

• Last Update Posted (Actual): July 10, 2026
• Last Update Submitted That Met QC Criteria: July 8, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: let lag, dyssynchrony syndrome
• Additional Relevant MeSH Terms: Travel-Related Illness; Nervous System Diseases; Mental Disorders; Sleep Wake Disorders; Dyssomnias; Chronobiology Disorders; Sleep Disorders, Circadian Rhythm; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Jet Lag Syndrome; Investigative Techniques; Diagnostic Techniques and Procedures; Diagnosis; Circulatory and Respiratory Physiological Phenomena; Metabolism; Hemodynamics; Cardiovascular Physiological Phenomena; Weights and Measures; Physical Examination; Oxygen Saturation; Pulse
• Other Study ID Numbers: Fit-Lag-211

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No